FOI 26.27 0454 Decision Documents

DOCUMENT 1 FOI 26/27-0454

OFFICIAL

Research – Therapy Best Practice

Please note:

The research and literature reviews collated by our TAB Research Team are not to be shared external to the Branch. These are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision-making.

Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on access or planning matters they are to call the TAPS line for advice.

The Research Team are unable to ensure that the information listed below provides an accurate & up-to-date snapshot of these matters.

The contents of this document are OFFICIAL

1 Contents

2 Summary ……………………………………………………………………………………………………………………….. 2

3 Parkinson’s disease …………………………………………………………………………………………………………. 3

3.1 Clinician involved in management ……………………………………………………………………………… 3

3.2 Best practice treatment and frequency of intervention ………………………………………………… 3

4 Multiple sclerosis ……………………………………………………………………………………………………………. 4

4.1 Clinician involved in management ……………………………………………………………………………… 5

4.2 Best practice treatment and frequency of intervention ………………………………………………… 6

5 Muscular dystrophy ………………………………………………………………………………………………………… 7

5.1 Clinician involved in management ……………………………………………………………………………… 7

5.2 Best practice treatment and frequency of intervention ………………………………………………… 8

6 Dementia ……………………………………………………………………………………………………………………….. 9

6.1 Clinician involved in management ……………………………………………………………………………… 9

6.2 Best practice treatment and frequency of intervention ………………………………………………… 9

7 Huntington’s disease ……………………………………………………………………………………………………… 11

7.1 Clinician involved in management ……………………………………………………………………………. 11

7.2 Best practice treatment and frequency of intervention ………………………………………………. 11

8 Arthritis ……………………………………………………………………………………………………………………….. 13

9 Chronic fatigue syndrome ………………………………………………………………………………………………. 14

9.1 Clinician involved in management ……………………………………………………………………………. 15

9.2 Best practice treatment and frequency of intervention ………………………………………………. 15

10 Chronic pain ……………………………………………………………………………………………………………… 16

11 Amputation ………………………………………………………………………………………………………………. 17

11.1 Clinician involved in management ……………………………………………………………………………. 17

11.2 Best practice treatment and frequency of intervention ………………………………………………. 18

12 References ……………………………………………………………………………………………………………….. 20

2 Summary

• Information provided has been obtain from a rapid review of the literature. This includes best practice guidelines, systematic reviews from the Cochrane Collaboration and other high quality meta-analyses and reviews.
• The personal circumstances, goals of each individual, and severity of the disease impacts the level of intervention required. Therefore, it is often not possible to provide an exact number of hours required for each intervention. This is reflected in the literature as studies investigating the same intervention often deliver it at a different frequency, leading to a lack of agreement around gold standard levels.
• If the agency requires precise numbers around how many hours of intervention are useful per clinician they will need to commission systematic reviews of each type of intervention delivered, across various disease severities. This is a substantial tasks. Current literature

focuses on the effectiveness rather than the intensity of intervention. The level of intervention is often decided by the allied health professional looking after the patient.

3 Parkinson’s disease

3.1 Clinician involved in management

A systematic review and meta-analysis of integrated care in Parkinson’s disease provides a list of core team members to be included in interventions [1].

• Movement disorders specialist
• General neurologist
• PD specialist nurse
• Physiotherapist
• Occupational therapist
• Speech therapist
• Clinical psychologist
• Neuropsychologist
• Community mental health team
• Social worker
• Dietician

Models of care varied significantly, ranging from 4-8 weeks, 1-4 sessions a day (30 minutes to 2 hr per session) ranging from 1-7 days a week. No indication of what hours were allocated to each profession.

3.2 Best practice treatment and frequency of intervention

Recommendations for treatment are taken from the NICE UK guidelines [2].

1. First-line treatment a. Offer levodopa to people in the early stages of Parkinson’s disease whose motor symptoms impact on their quality of life. b. Consider a choice of dopamine agonists, levodopa or monoamine oxidase B (MAO-B) inhibitors for people in the early stages of Parkinson’s disease whose motor symptoms do not impact on their quality of life.
2. Non-pharmacological management a. Nurse specialist interventions i. Clinical monitoring and medicines adjustment. ii. A continuing point of contact for support, including home visits when appropriate.

iii. A reliable source of information about clinical and social matters of concern to people with Parkinson’s disease and their family members and their carers (as appropriate). b. Physiotherapy and physical activity [3] i. General physiotherapy: 4 weeks to 12 months. Only 2 studies reported duration of sessions which included 12 hrs over 4 weeks and 18 hrs over 6 weeks. ii. Exercise: Treatment sessions lasted from 30 minutes to two hours, and took place over a period of three to 24 weeks. iii. Treadmill: Treatment sessions lasted from 30 to 60 minutes, and took place over a period of four to eight weeks. iv. Cueing: Treatment sessions lasted from four to 30 minutes and took place over a period of a single session to 13 weeks. v. Dance: Dance classes lasted one hour over 12 to 13 weeks, with a trained instructor teaching participants the tango, waltz, or foxtrot. vi. Martial arts: Treatment lasted one hour and took place over a period of 12 to 24 weeks c. Speech and language therapy [4] i. Median duration of therapy for those treated was four weeks with 68% attending a single weekly session, a further 22%, who were predominantly receiving Lee Silverman Voice Therapy (LSVT), had four or more therapy sessions per week. Most sessions (80%) lasted between 30‐60 minutes. d. Occupational therapy [5] i. A Cochrane Review from 2007 only found 2 studies that met inclusion criteria. These studies delivered intervention of 12 hours across 4 weeks, and 20 hours over 5 weeks. e. Nutrition [6] i. Monitoring every four to six weeks if there have been any changes to medications or treatment plan, with particular focus on the swallowing recommendations. ii. Every three months if the patient’s condition is stable. iii. For oral nutrition support, regular review of ONS prescriptions every three months is advisable, to ensure the appropriateness of the intervention. iv. Some centres offer one-day holistic reviews to re-assess mobility, swallow, speech and nutritional status.

*Dysphagia management should be conducted by speech and language therapists in conjunction with nurses and dietitians. No information provided on level/duration of intervention [7].

3. Deep brain stimulation a. Surgery is performed to implant a device that sends electrical signals to brain areas responsible for body movement. Electrodes are placed deep in the brain and are connected to a stimulator device.

4 Multiple sclerosis

4.1 Clinician involved in management

There is variation in the make-up of MS multidisciplinary teams. The NICE MS Clinical Guideline states that: “As a minimum, the specialist neurological rehabilitation service should have as integral members of its team, specialist [8, 9]:

• Doctors (GPs, Neurologist)
• Nurses
• Physiotherapists
• Occupational therapists
• Speech and language therapists
• Dieticians
• Continence specialists
• Clinical psychologists
• Ophthalmologist/orthoptist
• Social workers.

General rehabilitation – patients must be seen for 6-8 sessions or for a 6-8 week period, however, appointments should be booked according to the needs of the patient [8]. The figure below describes the level of dependency on specialist services for varying levels of disease severity.

Figure 2: Self Management/Specialist Service Dependency Model for People with MS

[Diagram showing Self Management, Supported Self Management, Co-ordinated Multi-Disciplinary Team Support, and Emergency or Unscheduled Care]

Patients are able to move fluidly in both directions between the different aspects of care illustrated, and such moves can be triggered either by the patient or their carer, or by the service professionals.

4.2 Best practice treatment and frequency of intervention

Determine how often the person with MS will need to be seen based on [9]:

• Their needs, and those of their family and carers
• The frequency of visits needed for different types of treatment (such as review of disease-modifying therapies, rehabilitation and symptom management).
  • “Review information, support and social care needs regularly”

The below interventions are listed in the NICE UK guidelines for the management of MS [9]

1. Exercise programs
2. Mindfulness-based training
3. Cognitive behavioural therapy
4. Fatigue management
5. Mobility rehabilitation
6. Spasticity management

7. Occupational therapy – memory or cognitive problems
8. Diet
9. Ocular rehab

A Cochrane Review of Multidisciplinary Rehabilitation (MD) for the treatment of MS has been conducted to determine its effectiveness [10]. The concept of MD comprises elements of physical therapy, occupational therapy, speech pathology, psychology and or neuropsychology, cognitive therapy and or behaviour management, social work, nutrition, orthotics, counselling input, recreation and vocational therapy.

Intensity of MD rehabilitation programme was subdivided into ‘high’ or ‘low’ intensity

• High intensity therapy involved input from at least two disciplines, a minimum of thirty minutes per session and total duration of at least 2‐3 hours of interrupted therapy per day for at least 4 days per week. This is usually provided in inpatient settings and some outpatient programmes.

• Low intensity programmes varied, the intensity and duration of therapy was lesser than that provided in inpatient rehabilitation settings and was dependent upon the type of rehabilitation setting and available resources

From this review, it has not been possible to suggest best ‘dose’ of therapy, further studies are needed to suggest optimum number, duration and intensity of treatment sessions.

Neuropsychological rehabilitation

A Cochrane Review of neuropsychological rehabilitation (delivered by psychologists) for MS was conducted in 2014 [11]. It found that the number of intervention sessions varied from eight to 36, the duration of the rehabilitation intervention from four weeks to six months, and the frequency from two times per month to five times per week. When analysing the results with regard to the number of sessions, duration and frequency, no definite conclusions can be drawn about the effect of these factors on rehabilitation outcomes.

Exercise

Ranging from 6 to 24 weeks in duration, ranging from once to 5 times weekly frequency [12].

5 Muscular dystrophy

5.1 Clinician involved in management

Muscular dystrophy (MD) is a group of diseases that cause progressive weakness and loss of muscle mass. The most common form of MD is Duchenne’s MD which most commonly occurs in young boys. The below will be presented for Duchenne’s MD.

The care team should include a [13]:

• Neurologist with expertise in neuromuscular diseases
• Physical medicine and rehabilitation specialist

• Physiotherapist
• Occupational therapists.
• Speech-language pathologists
• Orthotist
• Psychologist
• Dietician.

Some people might also need a lung specialist (pulmonologist), a heart specialist (cardiologist, a sleep specialist, a specialist in the endocrine system (endocrinologist), an orthopedic surgeon and other specialists.

5.2 Best practice treatment and frequency of intervention

Several types of therapy and assistive devices can improve the quality and sometimes the length of life in people who have muscular dystrophy. Examples include [13]:

• Range-of-motion and stretching exercises. Muscular dystrophy can restrict the flexibility and mobility of joints. Limbs often draw inward and become fixed in that position. Range-of-motion exercises can help to keep joints as flexible as possible.
• Exercise. Low-impact aerobic exercise, such as walking and swimming, can help maintain strength, mobility and general health. Some types of strengthening exercises also might be helpful.
  • Optimal exercise modality and intensity of exercise for people with a muscle disease is still unclear. Large variation in frequency, duration and intensity exists within the literature [14-16].
• Braces. Braces can help keep muscles and tendons stretched and flexible, slowing the progression of contractures. Braces can also aid mobility and function by providing support for weakened muscles.
• Mobility aids. Canes, walkers and wheelchairs can help maintain mobility and independence.
• Psychosocial intervention
• Gastrointestinal and nutritional management

Guidelines published for the diagnosis and management of Duchenne’s MD essentially states that patients should be assessed/reviewed every 6 months by allied health professionals involved in their multidisciplinary care [17].

There is no specific guidance on how many hours/visits are required for each rehabilitation intervention or clinician.

“Provide direct treatment by physical and occupational therapists, and speech-language pathologists, based on assessments and individualised to the patient.”

The above also goes for psychological assessment and intervention. The number of visits will depend on the patient’s current needs and ability to cope with their diagnosis.

6 Dementia

6.1 Clinician involved in management

The needs of people with dementia vary widely and tailoring care to each person’s circumstances can be complex. A multidisciplinary approach in which different health professionals work together is important [18].

A medical specialist is required to make a dementia diagnosis. These include:

• General physicians
• General practitioners
• Geriatricians
• Neurologists
• Psychiatrists
• Rehabilitation physicians

A number of different allied health professionals may be required at different points in time, including but not limited to [19]:

• Audiologists
• Dentists
• Dietitians
• Occupational therapists
• Orthoptists
• Physiotherapists
• Podiatrists
• Psychologists
• Social workers
• Speech pathologists

Nurses and aged care workers are also involved in the care of patients with dementia.

6.2 Best practice treatment and frequency of intervention

Best practice care has been taken from the UK NICE guidelines on dementia [20]:

1. Person centred care a. Involving people in decision making b. Providing information c. Advance care planning
2. Care coordination a. Provide people living with dementia with a single named health or social care professional who is responsible for coordinating their care.
3. Interventions to promote cognition, independence and wellbeing

a. “Offer a range of activities to promote wellbeing that are tailored to the person’s preferences” – i.e. previous hobbies/interests b. Cognitive Stimulation for mild to moderate dementia i. Cochrane Review found that intervention ranged from 4 weeks to 24 months [21]. Median session length across the studies was 45 minutes, and the median frequency was three times a week, ranging from one to five times a week. The total possible exposure to the intervention varied dramatically, from 10 to 12 hours to 375 hours in the two‐year study. Across the 15 studies, the median exposure time was 30 hours. c. Group reminiscence therapy for mild to moderate dementia i. Cochrane Review concluded that duration and frequency of the sessions could differed. Sessions ranged from 2-8 times at either 1-2 hours (face to face or telephone) and were delivered by occupational therapists, trained recreation therapists [22]. d. Cognitive rehabilitation or occupational therapy for mild to moderate dementia i. A Cochrane Review found that intervention duration ranged from 2 to 104 weeks. Sessions ranged from 1-12 per week. More intense was classified as more than 3 formal sessions per week. Duration was 30 to 240 minutes. Those in day care facilities were often longer [23].

NOTE: The Cochrane Collaboration have undertaken various reviews of non-pharmacological interventions for dementia and found that many lack convincing evidence or well described treatment protocols. These include homeopathy, acupuncture, aromatherapy, snoezelen, validation therapy or dance movement therapy.

There is promising evidence that exercise programs may improve the ability to perform ADLs in people with dementia, although some caution is advised in interpreting these findings. Included studies were highly heterogeneous in terms of subtype and severity of participants’ dementia, and type, duration, and frequency of exercise [24].

4. Pharmacological interventions a. acetylcholinesterase (AChE) inhibitors donepezil, galantamine and rivastigmine as monotherapies are recommended as options for managing mild to moderate disease
5. Caregiver education and skills training a. A meta-analysis of 23 randomized clinical trials provides strong confirmation of the benefits of caregiver education and skills training interventions for reducing behavioural symptoms [19]. Collectively, these trials involved 3,279 community-dwelling caregivers and patients. Effective interventions were wide-ranging and included caregiver education, skills training (problem solving, communication strategies), social support (linking caregivers to others), and/or environmental modifications (assistive device use, creating a quiet uncluttered space). Interventions varied in dose, intensity, and delivery mode (telephone, mail, face-to-face, groups, computer technologies. b. Successful interventions identified included approximately nine to 12 sessions tailored to the needs of the person with dementia and the caregiver and were

delivered individually in the home using multiple components over 3–6 months with periodic follow-up [19].

While pharmacological intervention can be conveniently packaged and standardised, with a measured dose, non-pharmacological interventions can be more difficult to evaluate [25]. The same intervention may be used in different studies, but it may comprise quite different components [25]. Non-pharmacological interventions have rarely used a standardised treatment manual; mainly due to the range of individual differences between people with dementia [25].

Although some interventions can be offered for a discrete period of time, such as half an hour per day, many others involve intervention at the level of the care setting or in the general approach or interactive style of those providing care (i.e. depends on disease severity, level or care and care providers) [25].

Frequency of intervention is briefly mentioned in the Australian Clinical Practice Guidelines and Principles of Care for People with Dementia [18]. Statements include:

• Health system planners should ensure that people with dementia have access to a care coordinator who can work with them and their carer’s and families from the time of diagnosis. If more than one service is involved in the person’s care, services should agree on one provider as the person’s main contact, who is responsible for coordinating care across services at whatever intensity is required.
• A care plan developed in partnership with the person and his or her carer(s) and family that takes into account the changing needs of the person.
• Formal reviews of the care plan at a frequency agreed between professionals involved and the person with dementia and/or their carer(s) and family.

7 Huntington’s disease

7.1 Clinician involved in management

The multidisciplinary team assesses the stage of the disease and formulates, coordinates and implements the individual care and treatment plan and consists of [26]:

• Physician
• Psychologist
• Speech and language therapist
• Social worker
• Occupational therapist
• Case manager
• Psychologist
• Dentist/oral health specialist

7.2 Best practice treatment and frequency of intervention

Only non-pharmacological recommendations will be presented [27].

Motor Disorders

• Chorea
  • Mouth guards splints.
  • Physiotherapy, OT, speech intervention to assess protective measures.
• Dystonia
  • Active and passive rehabilitation with a physiotherapist to maintain range of movement.
• Rigidity
  • Physiotherapy is recommended to improve or maintain mobility and prevent the development of contractures and joint deformity.
• Swallowing disorders
  • Motor skills training with speech therapist.
  • Psychology for mood, behaviour, emotional status and cognition
  • Provision of information and advice by a dietician, on food textures and consistency and food modifications, bolus size and placement, safe swallowing procedures, elimination of distractions and on focusing attention on just one task at a time can help to avoid aspirations and leads to improvement of swallowing disorders.
• Gait and balance disorders
  • Rehabilitative methods (e.g. physiotherapy and occupational therapy) may improve walking and balance disorders and prevent from their main complications (falls, fractures, loss of autonomy). Interventions for gait and balance should start as early as possible and be continued and adapted throughout the progression of the disease.
  • Supervised low impact exercise.
• Manual dexterity
  • Management with physiotherapy and occupational therapy may be useful to reduce the functional impact of fine motor skill deterioration.
  • OT may suggest adaptive aids to compensate for the deterioration of manual dexterity (adapted cutlery, computer keyboard, adapted telephone, etc.)
• Global motor capacities
  • Referral to a physiotherapist is recommended in order to facilitate the development of a therapeutic relationship, promote sustainable exercise behaviours and ensure long-term functional independence. Exercise programs should be personalized (considering abilities and exercise capacity), goal directed and task specific.
• Cognition
  • Multiple rehabilitation strategies (speech therapy, occupational therapy, cognitive and psychomotricity) might improve or stabilise transitorily cognitive functions (executive functions, memory, language…) at some point of time in the course of the disease.
  • Cognitive stimulation
• Language and communication disorders
  • Communication disorders in HD are variable, requires comprehensive assessment of language and of other factors such as mood, motivation and behaviour.

• Multi-disciplinary input such as Speech & Language Therapy and Physiotherapy help to retain communication and social interaction
• The changing communication needs of the person with HD will be monitored and reassessed throughout the course of the disease to plan effective management strategies at all stages.
• Psychiatric disorders
  • Based on data from other neurodegenerative conditions, mindfulness-based cognitive therapy and Acceptance and Commitment Therapy may be useful.
  • Underlying triggers causing changes in mood or behaviour should be addressed.
  • The duration of treatment is generally for over 6 months and can be for several years

*Unable to find precise data on frequency or duration of interventions for each professional.

8 Arthritis

The main treatment for arthritis is Methotrexate.

The NICE UK guidelines provides the below recommendations [28].

Non-pharmacological management

• Physiotherapy
  • Adults with RA should have access to specialist physiotherapy, with periodic review
  • Improve general fitness and encourage regular exercise
    • 3 to 6 face to face sessions over 3-6 month period [29].
  • Learn exercises for enhancing joint flexibility, muscle strength and managing other functional impairments
  • Learn about the short-term pain relief provided by methods such as transcutaneous electrical nerve stimulators (TENS) and wax baths.
• Occupational therapy
  • Adults with RA should have access to specialist occupational therapy, with periodic review if they have:
    • Difficulties with any of their everyday activities, or
    • Problems with hand function.
• Hand exercise programmes
  • Consider a tailored strengthening and stretching hand exercise programme for adults with RA with pain and dysfunction of the hands or wrists if:
    • They are not on a drug regimen for RA, or
    • They have been on a stable drug regimen for RA for at least 3 months.

The tailored hand exercise programme for adults with RA should be delivered by a practitioner with training and skills in this area.

• Podiatry
  • All adults with RA and foot problems should have access to a podiatrist for assessment and periodic review of their foot health needs.

• Functional insoles and therapeutic footwear should be available for all adults with RA if indicated.
• Psychological interventions
  • Offer psychological interventions (for example, relaxation, stress management and cognitive coping skills [such as managing negative thinking]) to help adults with RA adjust to living with their condition.
  • Meta-analysis of psychological interventions for arthritis pain found that interventions tested were most commonly delivered in a total of nine sessions of 85 min duration, offered on a weekly or biweekly basis [30].
• Diet and complementary therapies
  • Inform adults with RA who wish to experiment with their diet that there is no strong evidence that their arthritis will benefit. However, they could be encouraged to follow the principles of a Mediterranean diet (more bread, fruit, vegetables and fish; less meat; and replace butter and cheese with products based on vegetable and plant oils).
  • Inform adults with RA who wish to try complementary therapies that although some may provide short-term symptomatic benefit, there is little or no evidence for their long-term efficacy.
  • If an adult with RA decides to try complementary therapies, advise them: these approaches should not replace conventional treatment.

Monitoring

Ensure that all adults with RA have:

• Rapid access to specialist care for flares
• Information about when and how to access specialist care, and
• Ongoing drug monitoring.

Consider a review appointment to take place 6 months after achieving treatment target (remission or low disease activity) to ensure that the target has been maintained.

Offer all adults with RA, including those who have achieved the treatment target, an annual review to:

• Assess disease activity and damage, and
• Measure functional ability (using, for example, the Health Assessment Questionnaire [HAQ]).
• Check for the development of comorbidities, such as hypertension, ischaemic heart disease, osteoporosis and depression.
• Assess symptoms that suggest complications, such as vasculitis and disease of the cervical spine, lung or eyes.
• Organise appropriate cross referral within the multidisciplinary team.

9 Chronic fatigue syndrome

9.1 Clinician involved in management

In most cases, a GP should be able to diagnose chronic fatigue syndrome (CFS). However, if, after a careful history, examination and screening investigations, the diagnosis remains uncertain, the opinion of a specialist physician, adolescent physician or paediatrician should be sought [31].

Other non-medical professionals include:

• Physiotherapists
• Occupational therapists
• Psychologists
• Social workers
• Dieticians

9.2 Best practice treatment and frequency of intervention

Care should be provided to people with CFS using a coordinated multidisciplinary approach. Based on the person’s needs, include health and social care professionals with expertise in the following [31, 32]:

• self-management strategies, including energy management
• symptom management
• managing flares and relapse
• activities of daily living
• emotional wellbeing, including family and sexual relationships
• diet and nutrition
• mobility, avoiding falls and problems from loss of dexterity, including access to aids and rehabilitation services
• social care and support
• support to engage in work, education, social activities and hobbies

No detailed information could be sourced around how many hours are required per clinician for each of these approaches. It is clearly stated that service providers should be “adapting the timing, length and frequency of all appointments to the person’s needs” [32].

There is still little evidence to support any particular management or intervention for CFS in primary care that can provide an effective early intervention [33]. The only two evidence based therapies recommended by NICE are:

• Cognitive Behavioural Therapy
  • Five to 16 sessions. Sessions ranged from 30 minutes to 150 minutes [34]
  • People with CFS should not undertake a physical activity or exercise programme unless it is delivered or overseen by a physiotherapist or occupational therapist who has training and expertise in CFS [32].

• Exercise Therapy
  • Duration of the exercise therapy regimen varied from 12 weeks to 26 weeks
  • three and five times per week, with a target duration of 5 to 15 minutes per session using different means of incrementation, often exercise at home [35]

10 Chronic pain

This is a very broad area. Treatments depend on location of pain. Musculoskeletal pain, particularly related to joints and the back, is the most common single type of chronic pain.

Information provided in the section on arthritis directly relates to the management of chronic pain.

A substantial systematic review by Skelly, Chou [36] investigated non-pharmacological interventions for chronic pain. Interventions that improved function and/or pain for ≥1 month included:

• Low back pain:
  • Exercise
  • Psychological therapy
  • Spinal manipulation
  • Low-level laser therapy
  • Massage
  • Mindfulness-based stress reduction
  • Yoga
  • Acupuncture
  • Multidisciplinary rehabilitation
• Neck pain
  • Exercise
  • Low-level laser
  • Mind-body practices
  • Massage
  • Acupuncture
• Knee osteoarthritis
  • Exercise
  • CBT
• Hip osteoarthritis
  • Exercise
  • Manual therapies
• Fibromyalgia
  • Exercise
  • CBT
  • Myofascial release massage
  • Mindfulness practices
  • Acupuncture

Substantial variability in the numbers of sessions, length of sessions, duration of treatment, methods of delivering the interventions and the experience and training of those providing the interventions present a challenge to assessing applicability [36].

The range and duration of sessions of interventions are provided below.

• Psychological therapy sessions ranged from six to eight, and the duration of therapy ranged from 6 to 8 weeks
• Exercise therapy ranged from 6 weeks to 12 months, and the number of supervised exercise sessions ranged from 3 to 52.
• Ultrasound therapy was 4 and 8 weeks and the number of sessions was 6 and 10.
• Laser therapy ranged from 2 to 6 weeks and the number of sessions ranged from 10 to 12.
• Manipulation therapy sessions ranged from 4 to 24 and the duration of therapy ranged from 4 to 12 weeks.
• Massage therapy ranged from 2 to 10 weeks and the number of massage sessions ranged from 4 to 24
• Mindfulness based stress reduction 1.5 to 2 hour weekly group sessions for 8 weeks.
• Yoga therapy ranged from 4 to 24 weeks and the number of sessions ranged from 4 to 48.
• Acupuncture therapy ranged from 6 to 12 weeks and the number of acupuncture sessions ranged from 6 to 15.
• Relaxation training and muscle performance exercise therapy were done in 30-minute sessions three times per week for 12 weeks,

11 Amputation

11.1 Clinician involved in management

The Limbs 4 Life is the peak body for amputees in Australia. They provide a list of professionals who assist with rehabilitation of amputees [37].

• Rehabilitation Consultant (doctor)
  • Oversees and coordinates medical care.
• Occupational Therapist
  • Helps adjust to day to day activities like: personal care, domestic tasks such as: meal preparation, accessing your place of residence, driving, education or work readiness. If you are an upper limb amputee the occupational therapist will assist you to set goals, teach you how to perform tasks, explore modifications required to achieve goals (e.g. changes within the home or workplace), explore equipment to assist with completing tasks and assist you with the functional training of your prosthesis.
• Physiotherapist
  • Design a tailored exercise program tailored. They will assist with balance, flexibility, strength and stamina. They will help with mobility aids such as: wheelchairs, walking frames, crutches and other assistive devices.
• Prosthetist

• Will look after the design, manufacture, supply and fit of the prosthesis. Together, you will discuss and decide on the prosthetic components to suit your needs and lifestyle.
• Psychologist
  • Supports individuals and fosters positive mental health outcomes and personal growth.
• Nursing team
  • Assists with your medications, personal hygiene, bathing and dressing and any wound care and diabetic management that is required.
• Dietitian
• Podiatrist

11.2 Best practice treatment and frequency of intervention

Physiotherapy

The physiotherapist progresses the patient through a programme based on continuous assessment and evaluation [38]. Through regular assessment, the physiotherapist should identify when the individual has achieved optimum function with a prosthesis, facilitating discharge to a maintenance programme.

The consensus opinion is that the physiotherapist should contribute to the management of wounds, scars, residual limb pain and phantom pain and sensation together with other members of the multidisciplinary team [38].

During prosthetic rehabilitation patients should receive physiotherapy as often as their needs and circumstances dictate [38].

Occupational therapy

The occupational therapy practitioner provides critical interventions, such as [39]

• identifying the client’s functional goals, which can include self-care, home management, work tasks, driving, child care, and leisure activities, and offering modifications to complete these goals if required
• analysing tasks and providing modifications to achieve functional goals
• providing education on compensatory techniques and equipment to accomplish tasks and activities
• providing prosthetic training
• identifying and addressing psychosocial issues

Occupational therapy intervention will vary according to individual needs, and phases of intervention may overlap, depending on the person’s progress [39].

The administration of interventions for phantom limb have been shown to range between one day and 12 weeks, with one to five sessions per week [40].

Psychology

Counselling and psychological support is available to the person and their valued others preoperatively and continues as part of lifelong management [41].

Experienced clinical counselling and psychological support should be available to assist with issues such as adjustment and pain management from the acute phase, and throughout lifelong management [41].

Psychosocial issues are evaluated and addressed as part of the overall treatment plan and reviewed regularly throughout the care journey [41].

No information could be sourced about how many sessions are required.

12 References

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2. National Institute for Health and Care Excellence (NICE). Parkinson’s disease in adults. 2017. Available from: https://www.nice.org.uk/guidance/ng71/resources/parkinsons-disease-in-adults-pdf-1837629189061.
3. Tomlinson CL, Patel S, Meek C, Herd CP, Clarke CE, Stowe R, et al. Physiotherapy versus placebo or no intervention in Parkinson’s disease. Cochrane Database of Systematic Reviews [Internet]. 2013; (9). Available from: https://doi.org//10.1002/14651858.CD002817.pub4.
4. Herd CP, Tomlinson CL, Deane KHO, Brady MC, Smith CH, Sackley CM, et al. Speech and language therapy versus placebo or no intervention for speech problems in Parkinson’s disease. Cochrane Database of Systematic Reviews [Internet]. 2012; (8). Available from: https://doi.org//10.1002/14651858.CD002812.pub2.
5. Dixon L, Duncan DC, Johnson P, Kirkby L, O’Connell H, Taylor HJ, et al. Occupational therapy for patients with Parkinson’s disease. Cochrane Database of Systematic Reviews [Internet]. 2007; (3). Available from: https://doi.org//10.1002/14651858.CD002813.pub2.
6. The Association of UK Dieticians. Best practice guidance for dietitians on the nutritional management of Parkinson’s. 2021. Available from: https://www.parkinsons.org.uk/sites/default/files/2021-02/Best%20practice%20guidance%20for%20dietitians%20on%20the%20nutritional%20management%20of%20Parkinson%27s%20FINAL.pdf.
7. Deane K, Whurr R, Clarke CE, Playford ED, Ben‐Shlomo Y. Non‐pharmacological therapies for dysphagia in Parkinson’s disease. Cochrane Database of Systematic Reviews [Internet]. 2001; (1). Available from: https://doi.org//10.1002/14651858.CD002816.
8. Dix K, Green H. Defining the value of Allied Health Professionals with expertise in Multiple Sclerosis. 2013. Available from: https://support.mstrust.org.uk/file/defining-the-value-AHPs.pdf.
9. (NICE) NIfHaCE. Multiple sclerosis in adults: management. 2019. Available from: https://www.nice.org.uk/guidance/cg186/resources/multiple-sclerosis-in-adults-management-pdf-35109816059077.
10. Khan F, Turner‐Stokes L, Ng L, Kilpatrick T, Amatya B. Multidisciplinary rehabilitation for adults with multiple sclerosis. Cochrane Database of Systematic Reviews [Internet]. 2007; (2). Available from: https://doi.org//10.1002/14651858.CD006036.pub2.
11. Rosti‐Otajärvi EM, Hämäläinen PI. Neuropsychological rehabilitation for multiple sclerosis. Cochrane Database of Systematic Reviews [Internet]. 2014; (2). Available from: https://doi.org//10.1002/14651858.CD009131.pub3.

12. Hayes S, Galvin R, Kennedy C, Finlayson M, McGuigan C, Walsh CD, et al. Interventions for preventing falls in people with multiple sclerosis. Cochrane Database of Systematic Reviews [Internet]. 2019; (11). Available from: https://doi.org//10.1002/14651858.CD012475.pub2.
13. Mayo Foundation for Medical Education and Research. Muscular Dystrophy 2021 [Available from: https://www.mayoclinic.org/diseases-conditions/muscular-dystrophy/symptoms-causes/syc-20375388.
14. Voet NBM, van der Kooi EL, van Engelen BGM, Geurts ACH. Strength training and aerobic exercise training for muscle disease. Cochrane Database of Systematic Reviews [Internet]. 2019; (12). Available from: https://doi.org//10.1002/14651858.CD003907.pub5.
15. Birnkrant DJ, Bushby K, Bann CM, Alman BA, Apkon SD, Blackwell A, et al. Diagnosis and management of Duchenne muscular dystrophy, part 2: respiratory, cardiac, bone health, and orthopaedic management. The Lancet Neurology [Internet]. 2018 2018/04/01/; 17(4):[347-61 pp.]. Available from: https://www.sciencedirect.com/science/article/pii/S1474442218300255.
16. Birnkrant DJ, Bushby K, Bann CM, Apkon SD, Blackwell A, Colvin MK, et al. Diagnosis and management of Duchenne muscular dystrophy, part 3: primary care, emergency management, psychosocial care, and transitions of care across the lifespan. The Lancet Neurology [Internet]. 2018 2018/05/01/; 17(5):[445-55 pp.]. Available from: https://www.sciencedirect.com/science/article/pii/S1474442218300267.
17. Birnkrant DJ, Bushby K, Bann CM, Apkon SD, Blackwell A, Brumbaugh D, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. The Lancet Neurology [Internet]. 2018 2018/03/01/; 17(3):[251-67 pp.]. Available from: https://www.sciencedirect.com/science/article/pii/S1474442218300243.
18. Guideline Adaptation Committee. Clinical Practice Guidelines and Principles of Care for People with Dementia. Sydney: Guideline Adaptation Committee; 2016. Available from: https://cdpc.sydney.edu.au/wp-content/uploads/2019/06/CDPC-Dementia-Guidelines WEB.pdf.
19. Brodaty H, Arasaratnam C. Meta-Analysis of Nonpharmacological Interventions for Neuropsychiatric Symptoms of Dementia. American Journal of Psychiatry [Internet]. 2012 2012/09/01; 169(9):[946-53 pp.]. Available from: https://doi.org/10.1176/appi.ajp.2012.11101529.
20. National Institute for Health Care Excellence. National Institute for Health and Care Excellence: Clinical Guidelines. Dementia: Assessment, management and support for people living with dementia and their carers. London: National Institute for Health and Care Excellence (UK)

Copyright © NICE 2018.; 2018. 21. Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database of Systematic Reviews [Internet]. 2012; (2). Available from: https://doi.org//10.1002/14651858.CD005562.pub2. 22. Möhler R, Renom A, Renom H, Meyer G. Personally tailored activities for improving psychosocial outcomes for people with dementia in community settings. Cochrane Database of Systematic Reviews [Internet]. 2020; (8). Available from: https://doi.org//10.1002/14651858.CD010515.pub2. 23. Bahar‐Fuchs A, Martyr A, Goh AMY, Sabates J, Clare L. Cognitive training for people with mild to moderate dementia. Cochrane Database of Systematic Reviews. 2019(3). 24. Forbes D, Forbes SC, Blake CM, Thiessen EJ, Forbes S. Exercise programs for people with dementia. Cochrane Database of Systematic Reviews [Internet]. 2015; (4). Available from: https://doi.org//10.1002/14651858.CD006489.pub4.

25. National Collaborating Centre for Mental Health. Dementia: A NICE-SCIE guideline on supporting people with dementia and their carers in health and social care: British Psychological Society; 2007. Dementia. 2014.

26. Veenhuizen RB, Kootstra B, Vink W, Posthumus J, van Bekkum P, Zijlstra M, et al. Coordinated multidisciplinary care for ambulatory Huntington’s disease patients. Evaluation of 18 months of implementation. Orphanet J Rare Dis [Internet]. 2011; 6:[77- pp.]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3253686/.

27. Bachoud-Lévi A-C, Ferreira J, Massart R, Youssov K, Rosser A, Busse M, et al. International Guidelines for the Treatment of Huntington’s Disease. Frontiers in Neurology [Internet]. 2019 2019-July-03; 10(710). Available from: https://www.frontiersin.org/article/10.3389/fneur.2019.00710.

28. National Institute for Health and Care Excellence (NICE). Rheumatoid arthritis in adults: management. 2018.

29. Peter WF, Swart NM, Meerhoff GA, Vliet Vlieland TPM. Clinical Practice Guideline for Physical Therapist Management of People With Rheumatoid Arthritis. Physical Therapy [Internet]. 2021. Available from: https://doi.org/10.1093/ptj/pzab127.

30. Dixon KE, Keefe FJ, Scipio CD, Perri LM, Abernethy AP. Psychological interventions for arthritis pain management in adults: A meta-analysis. Health Psychology [Internet]. 2007; 26(3):[241-50 pp.].

31. Working Group of the Royal Australasian College of Physicians. Chronic fatigue syndrome. Clinical practice guidelines–2002. Med J Aust [Internet]. 2002 May 6; 176(S9):[S17-s55 pp.].

32. National Institute for Health and Care Excellence (NICE). Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. 2020. Available from: https://www.nice.org.uk/guidance/gid-ng10091/documents/draft-guideline.

33. Hughes JL. Chronic Fatigue Syndrome and Occupational Disruption in Primary Care: Is There a Role for Occupational Therapy? British Journal of Occupational Therapy [Internet]. 2009 2009/01/01; 72(1):[2-10 pp.]. Available from: https://doi.org/10.1177/030802260907200102.

34. Price JR, Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for chronic fatigue syndrome in adults. Cochrane Database of Systematic Reviews [Internet]. 2008; (3). Available from: https://doi.org//10.1002/14651858.CD001027.pub2.

35. Larun L, Brurberg KG, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. Cochrane Database of Systematic Reviews [Internet]. 2019; (10). Available from: https://doi.org//10.1002/14651858.CD003200.pub8.

36. Skelly AC, Chou R, Dettori JR, Turner JA, Friedly JL, Rundell SD, et al. Agency for Healthcare Research and Quality: Comparative Effectiveness Reviews. 2020. In: Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US). Available from: https://www.ncbi.nlm.nih.gov/books/NBK556229/.

37. Limbs 4 Life. Your recovery 2021 [Available from: https://www.limbs4life.org.au/steps-to-recovery/your-rehabilitation-team.

38. Broomhead P, Dawes D, Hale C, Lambert A, Quinlivan D, Shepherd R. Evidence based clinical guidelines for the physiotherapy management of adults with lower limb prostheses. British Association of Chartered Physiotherapists in Amputation Rehabilitation; 2003. Available from: https://docuri.com/download/csp-guideline-bacpar 59c1cb4df581710b2860eb11 pdf.

39. Gulick K. The occupational therapy role in rehabilitation for the person with an upper-limb amputation. American Occupational Therapy Association [Internet]. 2007. Available from:

https://www.aota.org/About-Occupational-Therapy/Professionals/RDP/upper-limb-amputation.aspx. 40. Othman R, Mani R, Krishnamurthy I, Jayakaran P. Non-pharmacological management of phantom limb pain in lower limb amputation: a systematic review. Physical Therapy Reviews [Internet]. 2018 2018/03/04; 23(2):[88-98 pp.]. Available from: https://doi.org/10.1080/10833196.2017.1412789. 41. Innovation AfC. ACI Care of the Person following Amputation: Minimum Standards of Care. Australia; 2017. Available from: https://aci.health.nsw.gov.au/__data/assets/pdf_file/0019/360532/The-care-of-the-person-following-amputation-minimum-standards-of-care.pdf.

FOI 26/27-0454 DOCUMENT 2 Research paper

OFFICIAL – For Internal Use Only

Therapy for chronic incomplete cervical spinal cord injury

The content of this document is OFFICIAL.

Please note:

The research and literature reviews collated by our TAB Research Team are not to be shared external to the Branch. These are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision-making.

Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on access or planning matters, they are to call the TAPS line for advice.

The Research Team are unable to ensure that the information listed below provides an accurate & up-to-date snapshot of these matters

1. Contents

Therapy for chronic incomplete cervical spinal cord injury ………………………………………………… 1

1. Contents ………………………………………………………………………………………………………….. 1

2. Summary …………………………………………………………………………………………………………. 2

3. Improving function for chronic spinal cord injury…………………………………………………….. 2

4. Therapy targeting upper limb function ………………………………………………………………….. 2

5. References ………………………………………………………………………………………………………. 5

Research paper

OFFICIAL – For Internal Use Only

2. Summary

There is some evidence that therapy continues to be effective in improving upper limb function and strength for people in the chronic stage of cervical spinal cord injury. Conventional physiotherapy or occupational therapy focussing on hand and arm function is possibly effective in this cohort and participants may be benefited by conventional training combined with robot-assisted upper limb training and/or electrical stimulation. It may be more likely that benefit could be achieved for people with incomplete rather than complete injury.

However, the level of evidence reviewed is generally low to very low certainty. Insufficient evidence was found to determine optimal frequency or timing to achieve the possible benefits for upper limb function and strength. Insufficient evidence was found to determine whether gains were likely to be achieved after 5 years.

No studies were found investigating the efficacy of a delegated model of care for the people with chronic cervical spinal cord injury.

3. Improving function for chronic spinal cord injury

The chronic phase of spinal cord injury is usually defined as starting from 12 months post-injury and represents a period during which the neurological function of the person stabilises. Some sources indicate that functional gains can still be made up to 2 years post-injury and possibly longer in the case of incomplete injury (Spinal Cord Injury Guidelines, 2022; Willig et al, 2022; Kalsi-Ryan et al, 2021). Therapy and management during this phase will often focus on adaptive skill-building and preventing secondary complications (contracture, pressure sores, inactivity, weight gain, decline in strength and fitness) (Spinal Cord Injury Guidelines, 2022; Kalsi-Ryan et al, 2021).

Some evidence shows that functional outcomes may be improved during the chronic stage of spinal cord injury. Chiou et al (2022) found moderate quality evidence that arm-crank exercise could improve cardiorespiratory fitness in people with chronic spinal cord injury. However, the study does not differentiate effect for higher and lower levels of injury. A review from Figoni et al (2021) that looks specifically at those with higher level injuries found inconclusive evidence aerobic exercise could improve fitness for people with tetraplegia.

4. Therapy targeting upper limb function

Reviews analysing evidence into the effectiveness of therapies for improvement of upper limb function for people with people with chronic spinal cord injury have generally showed positive results from very low certainty evidence. One review found exercise interventions were able to improve upper extremity motor control and functional ability in people with chronic cervical spinal cord injury (Kloosterman et al, 2009). The authors noted good methodological quality in the included studies. However, later reviews tend to find positive results from very low certainty evidence. Lu et al (2014) found evidence that improvements in upper limb function and

Research paper

OFFICIAL – For Internal Use Only

strength was possible for people in the chronic stage of spinal cord injury. While they note that the internal validity of the studies was fair to good, the external validity was generally poor.

The Australian and New Zealand Clinical Practice Guidelines for the physiotherapy management of people with Spinal Cord Injury evaluate the evidence and clinical consensus surrounding physiotherapy management strategies for people with spinal cord injury (Glinsky et al, 2022). As of 2022, none of the management strategies that the authors identified were supported by good quality evidence, though many achieved high levels of clinical endorsement (refer to Table 1).

A more recent meta-analysis of variables associated with improved function hand-arm training programs for people with cervical spinal cord injury notes:

analysis of 8 training programmes showed that training programmes using only skill training or combined with strength and endurance training exhibited a moderate effect on [arm-hand skilled performance]. Training programmes that integrate the task-oriented training components: functional movements, clear functional goals, real-life object manipulation, multiple movement planes, total skill practice, context-specific environment, exercise variety, and bimanual practice demonstrated a moderate effect on [arm-hand skilled performance] (Bertels et al, 2023, p.9).

The authors also compared effect sizes for participants with complete and incomplete injuries, and for sub-acute and chronic stages. While the authors suggest that the results were no different for each group, they also note that the meta-analysis was not reported due to an insufficient number of studies.

Bertels et al (2022) also note that a minimum of 8 weeks seems to be required to achieve moderate effect size. However, they also note that dosage parametres are not reported consistently and were unable to identify optimal frequency or intensity of therapy to achieve clinically meaningful results.

Bertels et al (2022) note very low certainty evidence around robotic assisted therapy for upper limb function. They provide a strong consensus recommendation in favour of the therapy. More recent evidence provides inconsistent support for this recommendation. Ho et al (2023) reviewed seven studies looking into the effectiveness of robotic-assisted upper limb rehabilitation to improve upper limb function after cervical spinal cord injuries. Four of the studies showed statistically significant improvements in upper limb function and strength. The studies showing significant results in favour of the intervention (4 out of 7) were all small sample case-series or observational studies. The only randomised control trial included in the review did not produce a statistically significant effect.

Other recent studies have produced suggestive evidence. A 2023 observational study of 6 patients with chronic C5-7 level injury investigated the effects of the functional hand protocol. The participants were between 30 and 90 years old. Two participants were <2 years post-injury. The other four participants had sustained spinal cord injury between 13 and 35 years prior (Ciardi et al, 2023). The functional hand protocol is described as:

FOI ron pal Research paper

OFFICIAL For Internal Use Only

a structured shortening of fingers and thumb’s flexor muscles, so to make the patient able to perform light, functional and useful everyday grips; functional hand needs to be supported by the activity of radial extensor of carpus, or by an orthosis to stabilize the wrist (thus permits movement through biceps activation) (Ciardi et al, 2023, p.2).

The authors found that the functional hand protocol may improve hand function, even many years after injury.

Table 1 Evidence and consensus recommendations for physiotherapy interventions

(Source: Glinsky et al, 2022)

Therapy for SCI Page 4 of 6

PRE ah.

Research paper

OFFICIAL For Internal Use Only

| combined with strength training | | | | | | Electrical stimulation | Voluntary strength | Very low | - | Weak - | | Shoulder exercises | Pain | Very low | 81% | Strong + |

5. References

Bertels, N., Seelen, H., Dembele, J., & Spooren, A. (2023). Essential training variables of arm- hand training in people with cervical spinal cord injury: a systematic review. Journal of rehabilitation medicine, 55, jrm7147. https://doi.org/10.2340/jrm.v55.7147

Chiou, S. Y., Clarke, E., Lam, C., Harvey, T., & Nightingale, T. E. (2022). Effects of Arm-Crank Exercise on Fitness and Health in Adults With Chronic Spinal Cord Injury: A Systematic Review. Frontiers in physiology, 13, 831372. https://doi.org/10.3389/fphys.2022.831372

Ciardi, G., Lamberti, G., & Avanzi, M. (2023). Using “functional hand” protocol to improve hand function following a spinal cord injury: an explorative study. Acta bio-medica : Atenei Parmensis, 94(5), e2023255. https://doi.org/10.23750/abm.v94i5.14408

Ho, J. S., Ko, K. S., Law, S. W., & Man, G. C. (2023). The effectiveness of robotic-assisted upper limb rehabilitation to improve upper limb function in patients with cervical spinal cord injuries: a systematic literature review. Frontiers in neurology, 14, 1126755. https://doi.org/10.3389/fneur.2023.1126755

Figoni, S. F., Dolbow, D. R., Crawford, E. C., White, M. L., & Pattanaik, S. (2021). Does aerobic exercise benefit persons with tetraplegia from spinal cord injury? A systematic review. The journal of spinal cord medicine, 44(5), 690–703. https://doi.org/10.1080/10790268.2020.1722935

Glinsky J.V., Harvey L.A. and the Australian and New Zealand Physiotherapy Clinical Practice Guidelines consortium. (2022). Australian and New Zealand Clinical Practice Guideline for the physiotherapy management of people with spinal cord injury. https://sciptguide.com/about-guidelines/documents/

Kalsi-Ryan, S., Kapadia, N., Gagnon, D. H., Verrier, M. C., Holmes, J., (NA), Flett, H., Farahani, F., Alavinia, S. M., Omidvar, M., Wiest, M. J., & Craven, B. C. (2021). Development of Reaching, Grasping & Manipulation indicators to advance the quality of spinal cord injury rehabilitation: SCI-High Project. The journal of spinal cord medicine, 44(sup1), S134–S146. https://doi.org/10.1080/10790268.2021.1961052

Therapy for SCI Page 5 of 6 OFFICIAL Page 28 of 42

Research paper

OFFICIAL For Internal Use Only

Kloosterman, M. G., Snoek, G. J., & Jannink, M. J. (2009). Systematic review of the effects of exercise therapy on the upper extremity of patients with spinal-cord injury. Spinal cord, 47(3), 196–203. https://doi.org/10.1038/sc.2008.113

Lu, X., Battistuzzo, C. R., Zoghi, M., & Galea, M. P. (2015). Effects of training on upper limb function after cervical spinal cord injury: a systematic review. Clinical rehabilitation, 29(1), 3–13. https://doi.org/10.1177/0269215514536411

Spinal Cord Injury Clinical Guidelines. (2022). Physiopedia. https://www.physio- pedia.com/Spinal_Cord_Injury_Clinical_Guidelines

Willig RM, Garcia I, da Silva NSL, Corredeira R, Carvalho J. The effectiveness of community- based upper body exercise programs in persons with chronic paraplegia and manual wheelchair users: A systematic review. J Spinal Cord Med. 2022 Jan;45(1):24-32. doi: 10.1080/10790268.2020.1782608. Epub 2020 Jul 9. PMID: 32644024; PMCID: PMC8890546.

Therapy for SCI Page 6 of 6 OFFICIAL Page 29 of 42

DOCUMENT 3

Research – Length of High Intensity Intervention for ABI, SCI and

Amputees

Please note:

The research and literature reviews collated by our TAB Research Team are not to be shared external to the Branch. These are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision-making.

Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on access or planning matters they are to call the TAPS line for advice.

The Research Team are unable to ensure that the information listed below provides an accurate & up-to-date snapshot of these matters.

Research – Length of High Intensity Intervention for ABI, SCI and Amputees Page 1 of 13 Page 30 of 42

The contents of this document are OFFICIAL

1 Contents

2 Summary ……………………………………………………………………………………………………………………….. 2

3 Traumatic Brain Injury …………………………………………………………………………………………………….. 3

3.1 Length of time high therapy supports are effective ……………………………………………………… 3

3.2 Recovery Plateau …………………………………………………………………………………………………….. 3

3.3 Impairment two years after brain injury …………………………………………………………………….. 4

4 Spinal Cord Injury ……………………………………………………………………………………………………………. 4

4.1 Length of time high therapy supports are effective ……………………………………………………… 4

4.2 Recovery Plateau …………………………………………………………………………………………………….. 5

5 Amputation ……………………………………………………………………………………………………………………. 6

5.1 Length of time high therapy supports are effective ……………………………………………………… 6

5.2 Recovery Plateau …………………………………………………………………………………………………….. 6

6 References …………………………………………………………………………………………………………………… 11

2 Summary

• Because randomised controlled trials (RCTs) often have limited funding, interventions are rarely delivered past the 12 month mark. Because of this, we can only make assumptions about the effectiveness of rehabilitation for TBI past these timeframes.

  • The consensus is, the earlier intervention occurs the better.
  • The timeline and level of recovery differs between patients. Therefore, the length of rehabilitation should be guided by the patient’s needs.

• Most commonly, the plateau for TBI improvement is around the 2 year mark. However, various studies have put the range anywhere from 6 months to 2 years.

• Most spinal cord injury (SCI) cases reach a plateau by 9 months after injury. However, additional recovery may occur up to 12–18 months.

• There is no agreement on duration and intensity of intervention in the acute and post-acute phases of SCI

  • Most studies implement intervention over 6 to 12 weeks.
  • Rehabilitation should be implemented when patients are medically stable and can tolerate the required intensity.

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• Unable to determine a timeframe for plateau in relation to amputees, however, the time needed to progress through rehabilitation phases is consistently reported to be between 12 and 18 months.

3 Traumatic Brain Injury

3.1 Length of time high therapy supports are effective

Systematic reviews investigating intensive multidisciplinary rehabilitation (in the post-acute stage) on average implement the intervention for less than 6 months and follow up study participants anywhere between 6-24 months. Refer to Table 1 for more details.

The length of time over which rehabilitation may have its effects (always many months and usually several years) is usually longer than any funded research project [1].

Benefits of neurological rehabilitation typically accrue over several years, rather than over weeks or months. RCTs are typically conducted over a much shorter time. Definitive RCTs in this area should be funded to include follow-up over three to five years but this is rarely possible under existing funding programmes. Furthermore, studies with long follow up periods tend to have high dropout rates, leading to less meaningful results due to smaller sample [2].

For patients engaged in rehabilitation, intervention should be offered as intensively as possible and should begin as early as possible, although the balance between intensity and cost-effectiveness has yet to be determined [2].

3.2 Recovery Plateau

Review of the existing TBI cognitive recovery literature indicates that recovery does indeed occur after TBI and that recovery curves are likely to be differentially sensitive to both recovery domain and time [3]. Most studies have employed global measures of functional outcome including: vocational status, Glasgow Outcome Scale, the Disability Rating Scale, the Community Integration Questionnaire, and the Functional Independence Measure [3].

Recovery is detectable, asymptotic (when more than 3 points are measured), and commonplace after TBI. Studies remain ambiguous about the pace of change over time and the point at which a plateau in recovery is achieved [3]. Expressly, some studies observe continued recovery as late as 2 years post injury [4-6] while others note no further recovery after 1 year [3, 7], while still others indicate full recovery as early as 6 months post injury [8, 9]. The discrepancies between findings may be attributable to the disparity across studies with regard to both study design and outcome measures [10].

Longer term longitudinal studies investigating post injury outcomes have shown mixed results. Newcombe [11] found that veterans who had had a head injury in the showed no

Research – Length of High Intensity Intervention for ABI, SCI and Amputees Page 3 of 13 Page 32 of 42

evidence of deterioration many years after injury. This might have been due to the expert and systematic care they received very soon after the injury. But other researchers found that a proportion of patients deteriorated when assessed 10-20 years later. In contrast, Dams-O’Connor, Ketchum [12] found a decline in functioning and decreased independence 5 years post injury. Similar results were also found by Millar, Nicoll [13] and Olver, Ponsford [14], however, a percentage of patients did make improvements. Furthermore, Ponsford, Downing [2] assessed patients at 2, 5 and 10 years post injury and found that problems that were evident at two years post-injury persisted until 10 years post-injury.

Rate of improvement varies from person to person. Currently, we don’t know the exact reason why the rate is different between people. However, age, pre-injury health, abilities and severity of injury have an impact on recovery.

3.3 Impairment two years after brain injury

Research from the TBI Model System program offers information about recovery from a moderate to severe TBI at 2 years after injury [15].

• About 30% of people need some amount of assistance from another person.
  • This may be during the day, at night, or both. Over time, most people can move around again without help.
• Trouble with thinking is common.
  • This includes how fast a person can think. It also includes forming new memories. The severity of these problems varies.
• About 25% of people have major depression.
  • In some cases, it’s caused directly by the brain injury. In addition, people with TBI are also dealing with major changes in their lives caused by the trauma, including changes in employment, driving, and living circumstances.
• Just over 90% of people live in a private home.
  • Of those who were living alone when they were injured, almost half go back to living alone.
• About 50% of people can drive again, but there may be changes in how often they drive or when.
• About 30% of people have a job, but it may not be the same job they had before the injury.

4 Spinal Cord Injury

4.1 Length of time high therapy supports are effective

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A systematic review by Burns, Marino [16] sought to answer various questions relating the type and timing of acute and subacute SCI. The results found that the evidence base is limited for many fundamental questions related to rehabilitation following acute and subacute SCI and there is no agreement in relation to timing, intensity and response [16]. These knowledge gaps include the timing of rehabilitation, nature of rehabilitation (specific interventions), therapeutic dose (intensity, frequency, and duration), role and impact of patient and injury characteristics, cost-effectiveness and efficiency of alternative interventions [16].

Of the studies included in the systematic review, the intervention lasted anywhere from 6 to 12 weeks [16]. This is likely because of similar reasons mentioned above for TBI (i.e. lack of funding for trials). Follow up was up to 12 months.

Recommendations arising from this review include [17, 18]:

• Rehabilitation be offered to patients with acute SCI when they are medically stable and can tolerate required rehabilitation intensity. (Grade: Weak Recommendation; No included studies)

• Offer body weight–supported treadmill training as an option for ambulation training in addition to conventional overground walking, dependent on resource availability, context, and local expertise. (Grade: Weak Recommendation; Low Evidence)

• Individuals with acute and subacute cervical SCI be offered functional electrical therapy as an option to improve hand and upper extremity function. (Grade: Weak Recommendation; Low Evidence)

• Based on the absence of any clear benefit, suggest not offering additional training in unsupported sitting beyond what is currently incorporated in standard rehabilitation. (Grade: Weak Recommendation; Low Evidence)

4.2 Recovery Plateau

In the clinical management of spinal cord injury (SCI), neurological outcomes are generally determined at 72 h after injury using American Spinal Cord Injury Association scoring system [19]. This time-point has shown to provide a more precise assessment of neurological impairments after SCI [20]. One important predictor of functional recovery is to determine whether the injury was incomplete or complete. As time passes, SCI patients experience some spontaneous recovery of motor and sensory functions. Most of the functional recovery occurs during the first 3 months and in most cases reaches a plateau by 9 months after injury [19, 21, 22]. However, additional recovery may occur up to 12–18 months post- injury [19, 21, 22]. Long term outcomes of SCI are closely related to the level of the injury, the severity of the primary injury and progression of secondary injury.

Research – Length of High Intensity Intervention for ABI, SCI and Amputees Page 5 of 13 Page 34 of 42

5 Amputation

5.1 Length of time high therapy supports are effective

Unable to locate precise intensity and duration of multidisciplinary interventions for amputees. However, the US Department of Veterans Affairs have developed a clinical practice guideline for lower limb amputation [23]. For the purpose of the guideline, the postoperative continuum is separated into “phases”. These include

1. Preoperative phase
2. Immediate postoperative phase
3. Pre-prosthetic rehabilitation phase
4. Prosthetic training phase. A study by Johannesson, Larsson [24] found that 64% of participants obtained good function with their prosthesis within 6 months.
5. Rehabilitation and prosthesis follow up phase

The advancement through these phases is largely individualized, however the time needed to progress is consistently reported to be between 12 and 18 months [23].

The NSW Agency for Clinical Innovation states that follow-up should occur regularly in the initial period for example, fortnightly/monthly for a few months, then 3-monthly, then 6- monthly [25]. Once the residual limb has stabilised, follow-up should occur, at minimum, on an annual basis. This plan may vary depending on the needs of the person [25].

5.2 Recovery Plateau

Unable to locate any details relating to a recovery plateau for amputees in the literature. It is clear however, the length of time often required before maintenance intervention should be implemented.

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Table 1. Studies of rehabilitation following TBI, SCI or amputation

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Table 1. Studies of rehabilitation following TBI, SCI or amputation

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Table 1. Studies of rehabilitation following TBI, SCI or amputation

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Table 1. Studies of rehabilitation following TBI, SCI or amputation

(Note: This page is a continuation of the previous table columns/rows format layout from the source document.)

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25. NSW Agency for Clinical Innovation. ACI Care of the Person following Amputation: Minimum Standards of Care Australia; 2017. Available from: https://aci.health.nsw.gov.au/ data/assets/pdf file/0019/360532/The-care-of-the-person- following-amputation-minimum-standards-of-care.pdf.

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