Intensive therapy for children with Cerebral Palsy, quality of literature

‹ PrevPage 1 of 11 · Source p. 24Next ›

FOI 24/25-1215 DOCUMENT 3

Intensive therapy for children with Cerebral

Palsy, quality of literature

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

Research question: To provide a critical analysis regarding study quality for 7 papers of interest about intensive therapy for children with cerebral palsy.

Date: 24/02/2022

Requestor: Shannon redacted: [s47F- personal priv](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/)acy

Endorsed by (EL1 or above): n/a

Researcher: Aaron redacted: [s47F- personal privacy](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/) and Stephanie redacted: s47F- personal privacy

Cleared by: Stephanie redacted: s47F- personal privacy

1. Contents

Intensive therapy for children with Cerebral Palsy, quality of literature ……………………………….. 1

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

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

  3. Literature Review ……………………………………………………………………………………………. 3

  4. Appendix ……………………………………………………………………………………………………….. 9

  5. References ………………………………………………………………………………………………….. 10

  6. Version control ……………………………………………………………………………………. 11

FOI 24/25-1215

2. Summary

Analysis of quality of these research papers demonstrated quality of evidence rating ranging from low to high. In particular, the 2020 systematic review from Novak et al includes some high quality evidence regarding efficacy of certain interventions. Reasons for these rating assessments have been included in the table. Two papers were research protocols only, therefore the quality of the final research cannot be determined.

FOI 24/25-1215

3. Literature Review

Author Title Source Aim / Objective Methods Analysis of Quality
1 Novak et al. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy Current Neurology and Neuroscience Reports. 2020. 20:3 To systematically describe the best available evidence for cerebral palsy interventions in 2019. Systematic review of systematic reviews. Review conducted using Cochrane guidelines and reported according to PRISMA statement.
• NHMRC Level of Evidence of findings varies for treatment option. Where possible the reviewers assessed systematic reviews or randomly controlled trials (level I). Where high levels of evidence were not available, observational studies were included (level IV). This is reported clearly in Fig 2 (pp2-3) using the Evidence Alert Traffic Light System.
• Quality of evidence of included studies is reported as Strong positive, weak positive, weak negative, strong negative. These levels correspond to confidence in the evidence and whether evidence favours treatment or not. Strong positives are mostly based on high quality randomly controlled trials. Weak positives (“probably do it”) made up 66% of the data, however there was no statistical information from these original studies to determine the effect size that the GRADE ranking was based on.
2 Tinderholt Myrhaug et al Intensive training of motor function and functional skills among young children with cerebral palsy: a systematic review and meta-analysis BMC Pediatrics. 2014. 14: 292 To describe and categorise intensive motor function and functional skills training among young children with CP, to summarise the effects of these interventions, and to Systematic review of controlled trials. Search directed at material from 1948 to 2012 with a supplementary search of material between 2012 and

FOI 24/25-1215

Author Title Source Aim / Objective Methods Analysis of Quality
examine characteristics that may contribute to explain the variations in these effects. 2014. Evidence was analysed from 29 randomly controlled trials and 9 controlled before and after trials. identified relevant studies published between 2012 and 2014 that were not included in the analysis (additional file 2) but no follow up review has been published. More current evidence is available.
• Reasonable sample of 1407 children with a mean age of 7 (one of the selection criteria). Part of the sample must be over the age of 7 and therefore results may not generalise for effectiveness of intensity of supports in early intervention.
• 31 assessment tools were used across 29 published studies which makes comparison of results difficult.
• Risk of bias: over half of the trials reviewed (19) had a high risk of bias. Only 9 trials had a low risk of bias. The reminder could not be determined. The authors did not justify inclusion of studies with a high risk of bias and acknowledge that bias is likely to affect the results of the meta-analysis.
3 Arpino et al. Efficacy of intensive versus non intensive physiotherapy in children with cerebral palsy: a meta-analysis International Journal of Rehabilitation Research. 2010. 33:10 To compare the efficacy of intensive versus non-intensive rehabilitative treatment in children with cerebral palsy. Meta-analysis of 4 randomly controlled trials published between 1996 and 2007.

FOI 24/25-1215

Author Title Source Aim / Objective Methods Analysis of Quality
• The most recent study reviewed is from 2007. More current evidence is available.
• 3 of 4 studies reviewed were based in the UK.
• The total sample was 226 children, with 17 lost to follow-up.
• Due to the limited number of studies reviewed, the authors suggest the results should not be taken as strong evidence for the lack of effectiveness of intensive therapy.
4 Araneda et al Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial BMC Neurology. 2020. 20:243 To assess the effects of HABIT-ILE adapted for pre-school children with bilateral CP regarding functional, neuroplastic and biomechanical factors. Randomly controlled trial of HABIT-ILE. Sample of 50 children with CP aged 12 to 60 months. Treatment conducted over 2 weeks and compared to regular activity/rehab. Children assessed at baseline, 2 weeks after baseline and 3 months after baseline.
5 Park, E. Effect of physical therapy frequency on gross motor function in children with cerebral palsy. J. Phys. Ther. Scie. 28: 1888-1891. 2016. To investigate the effect of physical therapy frequency based on neurodevelopmental therapy on gross motor function in children with cerebral palsy. Observational, case series (no control group)

FOI 24/25-1215

Author Title Source Aim / Objective Methods Analysis of Quality
GMFM total however these correlations were small (reflecting a weak relationship).
• The author attributed the small correlations and non-significant correlations (with other gross motor function changes) to limitations with the outcome instrument without considering there just may not be the strong correlation between parameters that they had expected raises a risk of bias in their interpretation.
• Author indicates due to a lack of sufficient evidence that further studies should be conducted
6 Sorsdahl et al Long-term change of gross motor function in children with cerebral palsy; an observational study of repeated periods of intensive physiotherapy in a group setting European Journal of Physiotherapy, 2020, 22(3), 148-154. To investigate the effect of repeated periods of intensive physiotherapy in groups Prospective, observational case series (no control group)

FOI 24/25-1215

Author Title Source Aim / Objective Methods Analysis of Quality
• Participants and assessors were not masked to the intervention increasing the risk of bias.
• Multiple assessors may impact reliability of data, however they attempted to control inter-rater reliability through training of assessors
• Improvements may have been influenced by factors other than the intensive therapy
- Gross motor function increased more than expected over time (as expected from development curves) however it was noted that the age of the children included in the study “was during an age period where the motor development curves are on their steepest slope. Mass practice of skill acquisitions and motor activities against gravity in everyday life is quite common at this age, also in children with CP. Such everyday-life activities could have added to the results gained during the intensive training sessions”
- Also unclear how much the children practiced in their everyday life. No diary was kept that may highlight some benefits from activities other than the therapy
• Longitudinal data was collected for children who participated in 4 blocks of 6 weeks of intensive therapy. This data was collected from children over 11yrs

FOI 24/25-1215

Author Title Source Aim / Objective Methods Analysis of Quality
therefore treatment may have changed, therapist skills may have changed
• Demonstrated a statistically significant improvement of gross motor function for the group, but did not investigate whether the improvement was clinically significant for the individual child
7 Rahlin et al How does the intensity of physical therapy affect the Gross Motor Function Measure (GMFM-66) total score in children with cerebral palsy? A systematic review protocol. BMJ Open 2020;10:e036630.

FOI 24/25-1215

4. Appendix

Table 2 NHMRC Evidence of hierarchy

(National Health and Medical Research Council, 2009)

Table 3 GRADE Certainty Ratings

(BMJ, 2022)

FOI 24/25-1215

5. References

Araneda, R., Sizonenko, S. V., Newman, C. J., Dinomais, M., Le Gal, G., Ebner-Karestinos, D., Paradis, J., Klöcker, A., Saussez, G., Demas, J., Bailly, R., Bouvier, S., Nowak, E., Guzzetta, A., Riquelme, I., Brochard, S., & Bleyenheuft, Y. (2020). Protocol of changes induced by early Hand- Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial. BMC Neurology, 20(1), 1–10. https://doi.org/10.1186/s12883-020-01820-2

Arpino, C., Vescio M. F., De Luca, A., & Curatolo, P. (2010). Efficacy of intensive versus non-intensive physiotherapy in children with cerebral palsy: a meta-analysis. International Journal of Rehabilitation Research, 33(2), 165–171.

BMJ. (2022). What is GRADE? Accessed on 24/2/2022 from https://bestpractice.bmj.com/info/toolkit/learn-ebm/what-is-grade/

National Health and Medical Research Council. (2009). NHMRC levels of evidence and grades for recommendations for developers of guidelines. Accessed on 24/2/2022 from https://www.nhmrc.gov.au/sites/default/files/images/NHMRC%20Levels%20and%20Grades%20(20 09).pdf

Novak, I., Morgan, C., Fahey, M., Finch-Edmondson, M., Galea, C., Hines, A., Langdon, K., Namara, M. M., Paton, M. C., Popat, H., Shore, B., Khamis, A., Stanton, E., Finemore, O. P., Tricks, A., te Velde, A., Dark, L., Morton, N., & Badawi, N. (2020). State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Current Neurology & Neuroscience Reports, 20(2), 1–21.

Park, E.-Y. (2016). Effect of physical therapy frequency on gross motor function in children with cerebral palsy. Journal of Physical Therapy Science, 28(6), 1888–1891. https://doi.org/10.1589/jpts.28.1888

Rahlin, M., Duncan, B., Pottinger, H. L., & Howe, C. L. (2020). How does the intensity of physical therapy affect the Gross Motor Function Measure (GMFM-66) total score in children with cerebral palsy? A systematic review protocol. BMJ Open, 10(7). https://doi.org/10.1136/bmjopen-2019- 036630

Sorsdahl, A. B., Moe-Nilssen, R., Larsen, E. M., Lundal, S. H., Rieber, J., Skarstein, E., Kaale, H. K., & Strand, L. I. (2020). Long-term change of gross motor function in children with cerebral palsy; an

FOI 24/25-1215

observational study of repeated periods of intensive physiotherapy in a group setting. European Journal of Physiotherapy, 22(3), 148–154. https://doi.org/10.1080/21679169.2018.1564363

Tinderholt Myrhaug, H., Østensjø, S., Larun, L., Odgaard-Jensen, J., & Jahnsen, R. (2014). Intensive training of motor function and functional skills among young children with cerebral palsy: a systematic review and meta-analysis. BMC Pediatrics, 14, 292. https://doi.org/10.1186/s12887-014- 0292-5

6. Version control

Version Amended by Brief Description of Change Status Date
0.1 AHR908 Draft Draft 23-02-2022
1.0 SJP131 Review Cleared 24-02-2022