Research Request – NAPA Therapy

| Requester | Julie s22(1)(a)(ii) - irrelevant (Senior Technical Advisor – TAB) Katrin s22(1)(a)(ii) - irrelevant (Assistant Director – TAB) |

| Researcher | Jane s22(1)(a)(ii) - irrelevant (Research Team Leader - TAB) |

| Cleared by | Jane s22(1)(a)(ii) - irrelevant (Research Team Leader - TAB) |

Contents

• Key points…3
• What is NAPA? …4
• Intensive therapy …4
  • Difference between intensive therapy as described in the literature and NAPA therapy …5
• Suit therapy …6
• Cuevas Medek Exercise …8
• Home based programs …9
• Neuroplasticity and Gross Motor Function Classification Scores …10
• Progressive disorders …14
  • Congenital neuromuscular disorders …14
    • Physical therapy interventions …15
  • Neurodegenerative Disorders in Childhood …15
• Reference List …30

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

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Key points

The NAPA centre does not provide any guidelines or specifics around how they determine which interventions are delivered during their “intensive model of therapy,” or how they’re implemented (multidisciplinary or individual therapists?). The centre promotes that its therapy is “highly effective” and “cutting edge”, but without any protocols or published evidence to substantiate these claims it is near impossible to determine whether the program is effective and beneficial. Without any published evidence we can’t know:

• Which diagnosis or ages this intervention is suitable for
• What the long term results are or adverse effects (if any)
• What the appropriate dosage/intensity is, or
• When the patient has reached their maximal level of function

Based on the information provided on the NAPA website it is clear that the Therasuit, SpiderCage and Cuevas Medek Exercises are the key interventions delivered during the intensive program. Current literature does not support these interventions as best practice for cerebral palsy or ‘other’ neurological conditions.

There are intensive interventions (delivered >3 times a week) for cerebral palsy that are supported by the literature. These include resistance/strength training and interventions for upper limb function such as Constraint Induced Movement Therapy and Bimanual Training. However, these can be delivered in a patient’s home or normal environment which makes them highly feasible (and likely cost effective) – rather than attending a clinic for 2-6 hours a day or 3 weeks. Furthermore, systematic reviews comparing conventional therapy (1-2 times a week) to more intensive intervention have reported no clinically meaningful difference.

It is not clear from the NAPA website how patients are followed up after their intensive model of therapy or whether home programs are developed to consolidate any improvements. This is of concern given that home based programs have been shown in the literature to be highly beneficial. The NAPA centre does offer weekly therapy sessions (1 hr) with physiotherapists, occupational therapists and speech pathologists, however, this would only be appropriate for those who live in Sydney, and it is unclear whether these weekly sessions consist of conventional/best practice therapy or those delivered in the intensive model.

Information is provided within the document on neuroplasticity and motor function curves for children with CP. These enable prognosis of gross motor progress across all 5 levels of Gross Motor Function Classification System levels for ages 0 to 15.

Research update (05/03/2021)

A single systematic review and meta-analysis on garment/suit therapy has been added to the literature review. The findings of this study do not change the advice/outcomes of the original research document. Wells, Marquez [1] concluded “Whilst there is some evidence for the use of garment therapy it is not sufficiently robust to recommend the prescription of garment therapy instead of, or as an adjunct to conventional therapy options”.

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What is NAPA?

The Neurological and Physical Abilitation or “NAPA” centre uses what they call the ‘Intensive Model of Therapy’ (IMOT) when treating children with cerebral palsy (CP) and ‘other’ neurological disorders. Programs are customised for each patient and vary in time, duration, intensity and tools used. The program usually consists of 2-6 hours of treatment a day, 5 days a week over 3 weeks. This will depend on diagnosis, age, stamina, strengths/weaknesses, and ‘other’ factors.

The core interventions used are the NeuroSuit and Multifunctional Therapy Unit (SpiderCage) in the intensive therapy programs on children of all ages starting as young as age three. In addition, therapists deliver Cuevas Medek Exercise (CME).

It is claimed that their methods are “highly effective” and “children often advance to the next developmental skill or higher during the three-week program. For example, if a child is using a walker, it is not uncommon for them to gain the strength, balance and ability to walk with crutches.”

The centre also provides:

• Weekly therapy - available for physiotherapy, CME/MEDEK, occupational therapy, NeuroSuit (min. 2 hours), and speech therapy. Fortnightly appointments are not available.
• VitalStim swallowing therapy
• Developmental feeding therapy
• Speech therapy
• Telehealth – only available to patients with current therapy authorisation with NAPA are eligible

Intensive therapy

Intensive interventions for children with CP refers to the frequency and amount of training, the duration of the training session (minutes or hours), and the duration of the training period (weeks or months). [2, 3] The typical frequency of physical therapy for children with CP in an outpatient setting is not well documented, however, physiotherapy sessions are typically offered 1-2 times per week to young children with CP as reported in Norway, Canada and the US. [2, 4] Various studies investigating intensive therapy/training have typically considered 3 or more sessions per week to constitute ‘intensive’ compared to conventional treatment. [2, 5]

Although it has been hypothesized that the effectiveness of conventional therapy in children with CP may depend on the dosage of treatment (i.e. with intensive regimens being more effective), this assumption is far from proven. Various systematic reviews and meta-analyses (moderate to high quality) have been published that investigate dosages required to obtain improvements [6] and have compared conventional to intensive therapy [2, 5, 7] (see Table 1 for more in-depth data). The main outcomes from these reviews are as follows:

In relation to upper extremity therapy [6]

• Individual goals can be achieved with a dose of 14–25 hr of practice, using a combination of face-to-face therapy with practice at home (5.6 hr of face to face and 8.4 hr of home practice) for children over 4 years of age

• A threshold dose of between 30 (OR 3.25 [95% CI 0.9–12.2]) and 40 hrs (OR 3.75 [95% CI 1.0–14.2]) of practice clinically improves motor ability in the unilateral CP population. The average ratio of therapy: home practice was 70:30.
• Age-dose relationship suggested younger children (below the age of 8) are more likely to improve motor ability.
• No significant difference between intensive (>3x per week) and less frequent. Intensity did not predict success or fail of set goals (OR 1.08 [95% CI 0.2–6.3]).

*It is reasonable to assume that these figures can be transferred to other goal based functional tasks of the lower extremities.

Comparison of conventional to intensive treatment which target motor and functional skills (delivered by occupational therapist, physical therapist and/or physiotherapist) showed mixed results.

• Myrhaug, Østensjø [2] found that across the majority of studies included in their review, equal improvements were identified between intensive intervention and conventional therapy or between two different intensive interventions.
• Alternatively, Cope and Mohn-Johnsen [7] and Arpino, Vescio [5] found small positive treatment effects in favour of intensive therapy, however, based on the GMFM-88 manual the level of difference is not considered clinically important/noticeable. [8]

Taking a closer look at some of the high quality randomised controlled trials included in these meta-analyses it is clear that intensive and standard treatment can both lead to improvements in GMFM. Given that long term follow-up data is sparsely reported, and conventional treatment of 1-2 sessions per week still leads to significant improvements in motor and functional skills it is difficult to justify intensive treatment which is more costly, time consuming and tiring/stressful for children. [5]

In addition, there is research of reasonably low to moderate quality which looks at the potential benefits of intensive strength training. For example, strengthening programs with frequencies of up to 3 times a week demonstrate improvements in gait and function. [9-13] Protocols have more commonly been home/community based [9, 11, 12] and have reported changes in gross motor function [9, 11, 13] cadence, and walking speed. [9, 12, 13] Although these results are positive (and strength training is well recognised as a high quality treatment for CP), many studies did not include a control group to allow for comparison against lower dosages.

Difference between intensive therapy as described in the literature and NAPA therapy

Whilst there are positive findings in the literature (although rarely clinically important or shown to be sustained over the long term) relating to various types of intensive therapy, we must consider how this compares to the method proposed by NAPA.

The NAPA program usually consists of 2-6 hours of treatment a day, 5 days a week over 3 weeks. The vast majority of the literature investigating intensive interventions consists of 3-5 sessions (45-60 minutes in duration) a week over 5-12 weeks. The only other treatment which promotes a dosage as

Suit therapy

The original suit (Adeli suit) was developed for the Soviet space program in the late 1960’s and was referred to as the Penguin suit. It was designed to counteract the adverse effects of zero gravity including muscle atrophy and osteopenia, and maintain neuromuscular fitness during weightlessness. [16] In 1991, the Adeli suit incorporated a prototype of a device developed in Russia for children with CP and popularized by the EuroMed Rehabilitation Center in Mielno, Poland. [17] Since then, the suit has been popularised in different countries using different names (Therasuit, Neurosuit, PediaSuit etc.). [16, 18] These different suits are essentially the same thing, however, they are marketed according to their own ‘protocols’. The differences between these ‘protocols’ are not clear in the literature, and most interventions use a combination of suits with intensive physical therapy (i.e. 2-4 hr sessions, 5-6 days a week, over 3 or 4 weeks). [18] Non-peer reviewed literature from developers of these suits claim that the therapy is appropriate for children from 2 years of age to adulthood. [18, 19]

In addition to the suit, some protocols use ability exercise units or functional cages. These cages can be used in two ways: the ‘monkey cage’ uses a system of pulleys and weights to isolate and strengthen specific muscles; and the ‘spider cage’ (Figure 1) uses a belt and bungee cords to either assist upright positioning or practice many other activities that normally would require the support of more therapists. [18] Claims of “significant improvement” following body weight suspension training have been made, however, only 3 peer reviewed articles exist. All of which are

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methodologically weak and include small samples making it impossible to make conclusions about its effectiveness. [20-22]

Figure 1. Spider cage and universal therapy unit. Some of the many reported benefits include improving motor function and posture, [23] improving vertical stability (e.g. standing posture), [24] increasing range of motion, [25] providing proprioceptive input and improving the vestibular system improving symmetry, [26] increasing walking speed and cadence, [27] improving trunk, [28] control motor function (in all dimensions of Gross Motor Function Measure [GMFM]), [29] and self-care [30] capacity in children with CP. However, most of these studies are case reports or descriptive studies in which the methodological quality limits the possibility of supporting or rejecting the use of the suit therapy in clinical settings. Centres that offer suit therapy indicate that the therapy can help children diagnosed with: [31, 32]

• Cerebral Palsy
• Global Developmental Delays
• Traumatic Brain Injury
• Near Drowning Accidents
• Post stroke (CVA)
• Incomplete Spinal Cord Injury
• Ataxia
• Athetosis
• Spasticity
• Hypotonia
• Parkinson Disease
• Chromosomal Disorders
• Autism Spectrum Disorder

There are no published, peer-reviewed studies on any of the above listed diagnoses, except for CP. Three moderate to high quality systematic reviews were analysed to obtain evidence on the benefit of participation in intensive suit therapy for children and adolescents with CP. These reviews are summarised in Table 2 below. The main take-home messages from the analysis were:

• Evidence indicating greater functional benefit from participation in intensive suit therapy is limited.
• No studies investigated the feasibility (e.g. adherence/compliance) or cost-effectiveness of suit therapy
• It is not possible to draw conclusions regarding which children with CP may benefit more than others from suit therapies due to the limited evidence and heterogeneity of included participants (GMFCS level I-IV)
• There is no consensus with regard to frequency, intensity and timing due to the variability in doses delivered across studies. Often specific protocols (including other physical therapy interventions concurrently delivered) were not described in studies. This makes it extremely difficult to evaluate findings.

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• Results from a meta-analysis showed a small positive effect size for gross motor function at post treatment (g=0.46, 95% confidence interval [CI] 0.10–0.82) and follow-up (g=0.47, 95% CI 0.03– 0.90). This small effect does not support robust conclusions to prescribe or suggest this new and ‘promising’ approach to therapy.
• Furthermore, adverse effects such as overheating, respiratory compromise, toileting problems such as constipation and urinary leakage and peripheral cyanosis have been reported. [16, 33]

Cuevas Medek Exercise

Cuevas Medek Exercise (CME) is a specialised psychomotor therapy designed for infants with developmental delays, syndromes and conditions affecting the central nervous system. [34] CME therapy provokes the child’s automatic postural responses by exposing the infant to the influence of gravity through a variety of positions and exercises (approximately 3000 exercises exist). During CME, the therapist physically manipulates the child to stretch out tight muscles and train the muscles in groups. These manipulations eventually allow the child to gain control over his or her trunk, which is necessary to perform basic gross motor activities such as sitting, standing, and walking. Sessions begin on a table. Then, if the child is able to stand with ankle support, the floor is used. Floor exercises involve seven pieces of equipment, which can be configured in various ways to challenge the child’s sense of balance. Exercises are repeated until the reaction of the brain becomes automatic and the body reacts normally to situations where required to keep its balance. It should be noted that CME rejects the use of external supports (splints and walkers) and the exercises are manually applied by a therapist, rather than the patient having to physically make the movements themselves. Below is an excerpt from the thesis titled The social construction of disability and the modern-day healer by Vanderminden [35]which describes the process of CME as described by its creator, Ramon Cuevas.

“CME therapy can be exercised regardless of the emotional status of the child, while in classical approaches, if the child cries the therapy session is typically terminated. When considering a child’s muscle tone, classic approaches generally will not place a child with hyper tonicity or severe spasticity in the standing position. Conversely, CME therapy practices the exact opposite. CME therapy does not require a physician’s diagnosis of a child’s condition, but rather seeks to listen to the parent’s interpretation of the limitations of their child’s development and movement.” CME is claimed to be suitable for babies from 4 months old, until they are walking and climbing stairs, however due to the nature of the technique, therapists are only able to work with children of a certain weight (up to approximately 22.5kg/50 pounds). [34] The therapy is suggested to occur three times a week, twice a day, for 45 minutes per session. [36] Studies focused on CME are scarce. Apart from reports published by the creator of the technique, only two case reports published in very low ranked (Impact Factor <1.5) peer reviewed journals could be located. [36, 37] These studies report that technique leads to positive results, however, several factors need to be considered.

1. Treatment protocols were poorly reported

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Home based programs

Home programs have been used for years by families and therapists to increase the intensity of therapy, either between treatment sessions or during a break from therapy. Recent research into therapy intensity has concluded that home programs provide a pragmatic solution to achieving high dose therapy, thus overcoming existing systemic implementation barriers.[2, 40]

In relation to upper limb mobility, there is little evidence to support block therapy alone as the dose of intervention is unlikely to be sufficient to lead to sustained changes in outcomes. [40] There is strong evidence that goal-directed OT home programs are effective and could supplement hands-on direct therapy to achieve increased dose of intervention. [41] Embedding intervention in natural environments (e.g., home, preschool/school) has been suggested to lead to meaningful and generalizable improvements in function. [42]

Clinically proven high dose interventions such as bimanual training and constraint-induced movement therapy (CIMT) have been shown to be effective when delivered at home. [43-45] Home based interventions are beneficial, especially for interventions with dosages that are not feasible for most families.

Novak, Cusick [42] have developed five steps for delivering successful home based programs. This includes:

1. Establishing collaborative partnerships between therapist and caregivers
2. Having the child and family (not the therapist) set goals about what they would like to work on in the home environment
3. Establishing the home program by choosing evidence based interventions that match the child and family goals and empowering the parents to devise or exchange the activities to match the child’s preferences and the unique family routine
4. Providing regular support and coaching to the family to identify the child’s improvements and adjust the complexity of the program as needed; and
5. Evaluating the outcomes together

Based on the steps, therapy provided by NAPA would not be successful in a home based environment because:

Neuroplasticity and Gross Motor Function Classification Scores

Neuroplasticity is the brain’s adaptive capacity to encode experiences as well as learn new behaviours and skills. In children with CP, intervention before the age of seven is recommended for optimizing motor function and learning functional skills, because from a maturational and neuroplasticity perspective the greatest gains will be made during this window. [46-48]

A younger child with a GMFCS level I or II usually has a better developmental prognosis than an older child with a GMFCS level IV or V. [49]

Gross motor development curves based on age and GMFCS level have been created by Rosenbaum, Walter [46] to enable prognosis of gross motor progress (Figure 2). Following this, Hanna, Bartlett [50] created reference curves which plotted percentiles at the 3rd, 5th, 10th, 25th, 50th, 75th, 90th, 95th, and 97th percentiles within each GMFCS level (Figure 3-7). This can be used to determine percentage potential based using GMFCS scores.

Figure 2. Gross motor development curves representing average development predicted by the Gross Motor Classification System. The diamonds on the vertical axis identify 4 items of the 66-item Gross Motor Function

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Measure (GMFM-66) that predict when children are expected to have a 50% chance of completing that item successfully.

The GMFM-66 item 21 (diamond A) assesses whether a child can lift and maintain his or her head in a vertical position with trunk support by a therapist while sitting, item 24 (diamond B) assesses whether a child can maintain a sitting position on a mat without support from his or her arms for 3 seconds, item 69 (diamond C) measures a child’s ability to walk forward 10 steps without support, and item 87 (diamond D) assesses the task of walking down 4 steps by alternating feet with arms free.

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Figure 3. Gross Motor Function Classification System level I percentiles.

Figure 4. Gross Motor Function Classification System level II percentiles

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Figure 5. Gross Motor Function Classification System level III percentiles

Figure 6. Gross Motor Function Classification System level IV percentiles

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Progressive disorders

Childhood neurodegenerative and neuromuscular disorders are rare, and usually have no cure. The natural history is often unknown and progression varies across patients.

Congenital neuromuscular disorders

Congenital neuromuscular disorders include:

• Muscular dystrophy
• Myotonic dystrophy
• Spinal muscular atrophy
• Peripheral neuropathies
• Generalised muscle and nerve issues (such as mitochondrial disorders)

The management of paediatric neuromuscular disorders is complex and challenging. Developing an effective management plan requires an understanding of the underlying pathophysiology, genetics, and natural history, as well as the interactions of normal maturation, treatment modalities, and the

Neurodegenerative Disorders in Childhood

Normal neural development and behaviour is relatively well understood, much less is known about the behavioural neurology of neurodegenerative deterioration in children. [53] It is unknown how the developing brain is impacted by progressive diseases at both a global and selective level. [53, 54] Frequently, the assessment of the severity of symptoms in children with neurodegenerative

environment. [51, 52] Optimum management requires a multidisciplinary approach that focuses on preventive measures as well as active interventions to address the primary and secondary aspects of the disorder. [51]

Physical therapy interventions

Active, active-assisted, and/or passive stretching to prevent or minimise contractures should be done a minimum of 4–6 days per week for any specific joint or muscle group. Stretching should be done at home and/ or school, as well as in the clinic. [51] Nowhere in the literature is there mention of providing short-term intensive therapy (physio, OT or speech) blocks as part of the management plan for neuromuscular disorders.

Figure X below provides a comprehensive overview of neuromuscular and skeletal management strategies for Duchenne muscular dystrophy. [51]

Figure X. neuromuscular and skeletal management strategies for Duchenne muscular dystrophy

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disorders (NDD) is difficult. Age and understanding of the child are always a factor and, in addition, many children suffer from brain damage or intellectual disability as a result of their disease. [53]

Treatment of children with NDD is directed towards the underlying disorder, other associated features, and complications. [55] The treatable complications include; epilepsy, sleep disorder, behavioural symptoms, feeding difficulties, gastroesophageal reflux, spasticity, drooling, skeletal deformities, and recurrent chest infections. [55] These children require a multidisciplinary team approach with the involvement of several specialties including paediatrics, neurology, genetics, orthopaedics, physiotherapy, and occupational therapy. [55] Many newer antiepileptic drugs are now available to treat intractable epilepsy. [54] owhere in the literature is there mention of providing short-term intensive therapy (physio, OT or speech) blocks as part of the management plan for NDD. An investigation by Olney, Doernberg [56] identified 104 progressive brain disorders of childhood which may be mistaken for CP. The natural history of many of these conditions is unknown as insuffient numbers of cases are reported in the literature. [56]

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Table 1: Literature investigating intensive therapy models

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[Image not converted to Markdown – “ndis” – check the source PDF page for the actual content]

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|(3) In children with cerebral palsy, is intervention performed at a higher intensity more effective than the same intervention performed at a lower intensity for improving motor function? (Intensity)|intervention must be provided by a PT or OT intervention may focus on upper and/or lower limb; outcomes measures include impairments of body structure/ function, activity limitations, and/or participation restrictions; participants must be children, birth to 18 years with a diagnosis of cerebral palsy; publication in peer-reviewed journals in any language with English version available; controlled trials with two or more groups.|hours over the treatment duration ranging from 6 to 78 hours.|

Results showed a small treatment effect favouring the higher dosage time (pooled g = 0.277, 95% CI 0.02, 0.534; I2 = 0%), however, this benefit is not clinically important.

All individual between group differences showed wide confidence intervals that crossed zero, suggesting both lack of precision in the computed effect sizes and the possibility that there was no difference between the groups.|Data extracted study design, sample size, subject demographics, intervention parameters, outcome measures, follow up procedures, baseline and post treatment group means and measures of variability, within-group change scores and measures of variability, and statistical significance for within group and between-group comparisons|

To describe and categorise intensive motor function and functional skills training among young children with CP, and to summarise the effects of these interventions.|38 studies included 1407 children with all levels of gross and fine motor function|Systematic review & Meta-Analysis Inclusion criteria: (a) a study population of CP with a mean age <7 years; (b) evaluated the effects of motor function (e.g., mobility and grasping) and functional skills training (e.g., eating and playing) performed three times or more per session.|

Only 6/38 studies performed intervention more than 1 hr a day. More common for 2-7 sessions a week + home training (19/38) and these were mainly hand function interventions. In a majority of the studies, equal improvements in motor function and functional skills were identified|

Moderate Small studies, often without power calculations, were also included. A variety of interventions were used to improve gross motor function and functional skills, which prevented the

|week at the clinic, in the kindergarden, or at home; (c) was compared to another intervention (e.g., conventional therapy), the same type of intervention provided less frequently, or another intensive intervention; and (d) with outcomes in the activity and participation components of the ICF [3], measured as hand function, gross motor function, and/or functional skills.|for intensive interventions and conventional therapy or between two different intensive interventions|Hand function (fine motor skills)|When compared with conventional therapy, CIMT performed for more than one hour per day showed significant effects on unilateral hand function in one meta-analysis (N = 2, [33,60] SMD 0.79 (95% CI 0.03, 1.55), p = 0.04). The CIMT groups performed 15–28 hours more training per week, which resulted in a difference of 29–84 training hours over two to three weeks compared with the conventional therapy groups.|Gross motor function|Too heterogeneous to be pooled in meta-analyses. All studies with significant results in favour of intensive training that targeted gross motor function had a high risk of bias.|Functional skills|CIMT performed at least 2–7 sessions per week with additional home training achieved more improvements in functional skills compared with conventional therapy (N = 3, [36,38,60] SMD 0.82 (95% CI 0.26, 1.38), p = 0.004) and (2) CIMT performed 2–7 sessions per week with additional home training achieved more improvements in functional skills compared with intensive bimanual home training (N = 4, [21,30,32,34] SMD 0.50 (95% CI 0.16, 0.83), p = 0.004)|

| — | Arpino, Vescio [5] | To assess whether intensive ‘conventional therapy’ is more effective than non-intensive ‘conventional therapy’ in children with CP whose clinical outcome was assessed with the GMFM. | hour per day with additional home training. The duration was categorised as ≤ four weeks, 5–12 weeks, or >12 weeks. | To assess whether intensive ‘conventional therapy’ is more effective than non-intensive ‘conventional therapy’ in children with CP whose clinical outcome was assessed with the GMFM. | Systematic review & Meta-analysis Type of study: RCT Type of participants: infant/children/adolescents (1–18 years old) affected by any type of CP. Outcome measure: GMFM. ‘intensive’ treatment was defined as any treatment provided more than 3 times per week; in a single study, additional sessions provided by an assistant defined the ‘intensity’ of the treatment. ‘Conventional therapy’ that which included physiotherapy or a neurodevelopmental approach. | Meta-analysis showed that the GMFM change score was higher for the intensive treatment group, compared with the non-intensive treatment group [difference of 1.32; 95% confidence interval (CI): 0.55–2.10]. Effect of intensive treatment tended to be stronger for children who were 2 years of age or younger (difference of 5; 95% CI: –0.45–10.45). In the RCTs in which treatment lasted for at least 60 days, it was higher in the intensive treatment group than in the non-intensive treatment group (difference of 1.42; 95% CI: 0.55–2.30). | High According to the GMFM-88 manual an increase of 1.82% points is the smallest change of clinical importance according to parents’ perception. Limited evidence to support intensive/additional physiotherapy. | Elgawish and Zakaria [41] | To assess gross motor progress in children with spastic (quadriplegic and diplegic) CP treated with intensive physical therapy (PT) as compared with a matched group treated with a standard PT regimen. | Intensive PT = 5 sessions (1hr each) a week, over 16 weeks | To assess gross motor progress in children with spastic (quadriplegic and diplegic) CP treated with intensive physical therapy (PT) as compared with a matched group treated with a standard PT regimen. | Randomised controlled trial Patients were randomly assigned to two treatment groups: group A and group B. Convenience sample. | After 8 weeks, there were significant differences between the two groups as regards the total scores of GMFM-88 and GMPM (P < 0.05). However, highly significant differences for GMFM-88 (P < 0.001) and only significant differences (P < 0.05) for GMPM were observed after 16 weeks. | Moderate Convenience sample. Randomisation not specified, no power calculation. Intensive PT led to greater motor function.

| — | | Christiansen and Lange [57] | to compare the effect of the delivery of the same amount of intermittent versus continuous physiotherapy given to children with cerebral palsy ( | Standard PT =2 sessions (1hr each), over 16 weeks 25 girls and 20 boys, aged between 2 and 6 Years GMFCS level I - V

Intermittent = physiotherapy 4x a week, 45 minutes per session for 4 weeks (period A) followed by 6 weeks without physiotherapy (period B). Periods A and B were repeated three times over 30 weeks with a maximum of 48 sessions Continuous = physiotherapy once or twice a week for 30 weeks, also for 45 minutes per session and with a maximum of 48 sessions Children were treated by ‘their own’ physiotherapist during the intervention Outcome measure | No statistically significant differences were found between the two groups as regards GMFM-66 scores after 8 weeks, and significant differences were found only after 16 weeks (P < 0.05). After 16 weeks, all dimensions of GMFM-88 were significantly increased in both groups (P < 0.001).

Both groups increased their GMFM scores significantly over the study period (I group p=0.026; C group p=0.038).

Result does not confirm the hypothesis that intermittent physiotherapy increases the GMFM-66 score more than continuous physiotherapy | Improvements. However, even 1hr, twice a week leads to significant improvements.

Moderate Convenience sample. Randomisation not specified. More studies required.

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• author and year of publication
• study design
• sample size and characteristics
• details of the intervention:
  • frequency, duration, suit type and settings
• activities performed and control intervention
• outcomes analysed using inferential statistics and the instrumentation used
• results obtained GRADE guidelines used to grade the strength of the recommendation of the intervention | 13 studies met inclusion criteria 285 children with different clinical types of CP aged 3-17 years with Gross Motor Function Classification System (GMFCS) level 1 to IV 6 RCT, 5 quasi-experimental designs, 2 single-subject experimental designs. Interventions with the suits ranged from three to 18 weeks, with usage times ranging between 30 min and 12 h/day. Different standardized instruments evaluated outcomes focusing on:
• Body structures and functions
• Activity Full Body Suit (FBS) n = 2
• Suit worn for 6 hrs a day for 6 weeks
• Conflicting results found between studies for mobility scores Dynamic Elastomeric Fabric Orthose (DEFO) (neoprene pants that exert pressure on the pelvis and promote hip external rotation and abduction and knee extension) n = 2
• Suit worn for 4-8 hrs a day over 6 weeks
• Not all participants increased walking speed
• Some improvements in knee alignment | Moderate Low to very low quality of evidence. Weak recommendations for all interventions, a strong negative recommendation for the use of the FBS. Selected studies did not have sufficient information about: (1) Direction and level of tension applied to the elastic elements in order to adjust the suits and (2) Exercises and activities conducted during the therapy sessions. (3) Sufficient and appropriate intensity and duration of suit wearing to enable effects (4) Which children with CP might be better candidates for obtaining the effect |

| Karadağ-Saygı and Giray [33] | To evaluate the clinical aspects and effectiveness of suit therapy for patients with cerebral palsy | Systematic Review | Inclusion | • Patients: Children (<18 years) with a diagnosis of CP • Intervention: Suit therapies • Comparison: Conventional therapy, neurodevelopmental therapy, or another therapeutic approach | Types of participants | • Age ranged between 3 and 14 years. • Sample size ranged from 16 to 51. • Fourteen (48.28%) of the studies did not report the GMFCS level of the participants.

Intervention protocols | Moderate | Heterogeneity of studies makes it difficult to provide any guidance for clinical practice. Small sample sizes of included studies and varying protocols | —|—|—| • Wearing this suit did not lead to significant difference in postural control TheraTogs n = 3 • Suit worn 12 hrs a day for 12 weeks • Significant improvement seen in gait kinematics across all studies compared to control groups TheraSuit Method (TSM) or AdeliSuit Therapy (AST) n = 6 • Both Therasuit studies found minimal gain (small positive effect sizes). • No statistically significant differences between groups [23, 27] • Some areas there was a decline in gross motor function [27] • Those with higher level motor function at baseline performed better [23] • Only care giver perception regarding the performance of tasks obtained a large effect size • Same findings relating to Adeli suit therapy |

| Outcome: The clinical aspects of studies (number of participants, age, CP type, Gross Motor Function Classification System (GMFCS) level, suit type, intervention including dose of suit therapy, outcome measurements, outcomes, adverse effects, and funding) | Study: All types of trials published in peer reviewed journals including RCTs and non-RCTs and other studies (single case studies or case series) | Data extracted | • Number of participants | • Age | • CP type, | • GMFCS level | • Suit type | • Intervention including dose of suit therapy | • Outcome measurements | • Adverse effects | | Intervention protocols varied within and between studies | | Suit designs also differed among studies and varied among study participants in some of the studies | | Nine (31.03%) of the studies investigated the effect of suit on upper limb function, while 10 of them investigated effects on lower limb function (e.g. gait analysis parameters, balance or walking performance tests) | | Types of outcome measures | | • The Gross Motor Function Measure was the most reported outcome | | • Participation evaluated using the International Classification of Functioning, Disability, and Health were limited | | • Seventeen (58.62%) of the studies did not report parental satisfaction or adverse effects. | Results synthesis | • A single RCT of high quality showed that full body suit therapy in additional to conventional therapy is beneficial in improving gross motor function in diplegic CP | • Moderate quality evidence from 4 RCTs showed that suit therapy in addition to conventional therapy yields no significant change in GMFM compared to conventional therapy in children with diplegic and tetraplegic CP. | • None of the studies investigated the feasibility (e.g adherence/compliance), and cost-effectiveness.

| — | Martins, Cordovil [16] | An overview of the efficacy of suit therapy on functioning in children and adolescents with cerebral palsy. | Systematic Review & Meta-Analysis | Inclusion criteria |- RCTs reported in peer-review journals |- Languages: English, Portuguese, Spanish and French |- Studies investigating the effect of suit therapy regardless of the type of protocol used (Pedia-Suit, TheraSuit, NeuroSuit, Adeli suit, Penguin suit, or Bungy suit); |- Studies conducted with samples that comprised children and adolescents (from 0–18y) with a clinical diagnosis of CP regardless of the type and level of severity |- Studies reporting functioning as the primary outcome, assessed by means of standardized and internationally accepted instruments (e.g. GMFM – 66 or 88 items and Paediatric Evaluation of Disability Inventory [PEDI]). | Data extracted |- Type of study design |- Sample size | Four studies were eligible and included in the review | 110 participants included | Mean number of participants in each trial was 12.3 (SD 2.52) with a mean age of 6 years 11 months (SD 1y 10mo). |- Two RCTs compared Adeli suit treatment with neurodevelopmental treatment (NDT) |- One study compared modified suit therapy with conventional therapy |- One compared TheraSuit with a treatment categorized as ‘other’ | Sample |- CP severity ranged from I to IV |- Subtypes included spastic, ataxic and dyskinetic |- Topographic distribution of motor signs – hemiplegia, diplegia and quadriplegia |- Total hours of treatment ranged from 30-60 | Adeli suit showed significant improvements in gross motor function after 1 month of treatment (p=0.037). However, there was a decrease in gross motor function at follow up (9 months) and not | High |- Overall, studies were rated as ‘fair’ to ‘good’ quality using the PEDRO scale. |- The results of the study point to limited effects of suit therapy in gross motor function of children and adolescents with CP, and considerable levels of heterogeneity between trials. |- The presence of potential co-interventions (such as additional interventions and home training of parents with their children) remained unclear in most studies and might have influenced outcomes. |- There is no consensus about the adequate duration of suit therapy programs. | NAPA Therapy Research

| — | Wells, Marquez | [1] | To conduct a systematic review asking, does garment therapy improve motor function in children with cerebral palsy? | | Systematic Review & Meta-Analysis | | Electronic searches of EMBASE, MEDLINE, Cochrane Library, PubMed, CINAHL and Proquest | | Inclusion criteria: Children <18 years, any sub classification of CP, intervention involved suit/garment therapy and included a measure of neuromuscular function | | 14 studies included in the review (n = 234) | | Age 15 months to 17 years (mean = 8.1 years). Primary reported impairment was spasticity (74.76%). | | 5 RCT, 9 were case studies (single case study, repeated measures or case report). | | 4 studies full body suits, 6 studies full body suits in conjunction with a strapping system, 2 upper limb | | Moderate | | Limited number and varying quality of studies. | | Whilst there is some evidence for the use of garment therapy it is not sufficiently robust to recommend the prescription of garment therapy. |

|garment, 1 study lower limb garment, 1 full body suit including gloves. Garment brands were Second Skin, the Adeli Suit, TheraTogs, TheraSuit, UpSuit, and Camp Lycra| |9 described adverse events that may have been a consequence of the intervention| |Intervention duration = 3-12 weeks| |Garment wear time = 2-12 hours per day| |Meta-Analysis| |Non-significant effect on post-intervention function as measured by the Gross Motor Function Measure when compared to controls (MD = −1.9; 95% CI = −6.84, 3.05).| |Non-significant improvements in function were seen long-term (MD = −3.13; 95% CI = −7.57, 1.31).| |Garment therapy showed a significant improvement in proximal kinematics (MD = −5.02; 95% CI = −7.28, −2.76), however significant improvements were not demonstrated in distal kinematics (MD = −0.79; 95% CI = −3.08, 1.49).|

Revision History

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