TY - JOUR
T1 - Implications of providing wrist-hand orthoses for children with cerebral palsy
T2 - evidence from a randomised controlled trial
AU - Imms, Christine
AU - Wallen, Margaret
AU - Elliott, Catherine
AU - Hoare, Brian
AU - Greaves, Susan
AU - Randall, Melinda
AU - Orsini, Francesca
N1 - Funding Information:
The MiT Authorship Group comprises: Christine Imms (University of Melbourne), Margaret Wallen (Australian Catholic University, Sydney), Catherine Elliott (Perth Children’s Hospital), Brian Hoare (Monash Children’s Hospital, Melbourne), Susan Greaves (The Royal Children’s Hospital, Melbourne), Melinda Randall (The Royal Children’s Hospital, Melbourne), Francesca Orsini (Murdoch Children’s Research Institute, Melbourne), Dinah Reddihough (Royal Children’s Hospital, Melbourne), Rob Carter (Deakin University, Melbourne), Sophy Shih (formerly Deakin University, Melbourne) and Brooke Adair (Murdoch Children’s Research Institute). Four students undertook aspects of their doctoral studies within the MiT, and we acknowledge their contributions to the study: Simon Garbellini, Corrin Walmsley, Utsana Tonmukayakul and Weiyang Code Xu. We would like to thank the children and parents who participated as well as the trial managers Melinda Randall, Alice Ames, Georgie Rose, site research and clinical staff (NSW Alison Francis, Kerrie Potgieter, Rahm Ranjan, Kylie Anne Good, Stacey Byrne, Ruth Evans; Victoria: Jesse Taylor, Bianca Valenzisi, Jacqui Irlam, Jen Cameron, Robyn Heesh; WA Luke Brennan, Belinda McLean, Sherilyn Nolan, Olivia Naylor, Sarah Dobbin, Susan Taylor, Catherine George, Sara Stapleton) who contributed to the MiT, and parent advisors who contributed their expertise to the Steering Group (Jacqui Wisemantel, Mel Weston) and Local Advisory Committees (NSW Justine Warton, Clare Lin, Rene Pereksles; WA Anne Roberts, Kathryn Strong; Victoria: Robyn Virgona and Andrea and Zoe Louziotis). We also thank our independent Data Monitoring Committee: Prof. Julie Bernhardt, Prof. Tom Sullivan and Dr Kirsty Stewart, and the clinicians who fabricated rigid-WHO. This study was supported by Intersect Australia Limited, who provided the platform for data exchange between sites. Learn more at www.intersect.org.au .
Publisher Copyright:
© 2022 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2023/6/5
Y1 - 2023/6/5
N2 - Purpose: To investigate the effects of providing rigid wrist-hand orthoses plus usual multidisciplinary care, on reducing hand impairments in children with cerebral palsy. Methods: A pragmatic, multicentre, assessor-blinded randomised controlled trial aimed to enrol 194 children aged 5–15 years, with wrist flexor Modified Ashworth Scale score ≥1. Randomisation with concealed allocation was stratified by study site and passive wrist range. The treatment group received a rigid wrist-hand orthosis, to wear ≥6 h per night for 3 years. Analysis included repeated measures mixed-effects linear regression models, using intention-to-treat principles. Results: The trial stopped early due to insufficient recruitment: 74 children, across all Manual Ability Classification System levels, were randomised (n = 38 orthosis group; n = 36 control). Mean age was 10.2 (SD 3.1) years (orthosis group) and 9.1 (SD 2.8) years (control). Data showed some evidence that rigid wrist-hand orthosis impacted passive wrist extension with fingers extended in the first year [mean difference between-groups at 6 months: 13.15° (95%CI: 0.81–25.48°, p = 0.04); 12 months: 20.94° (95%CI: 8.20–33.69°, p = 0.001)]. Beyond 18 months, participant numbers were insufficient for conclusive findings. Conclusion: The study provided detailed data about short- and long-term effects of the wrist-hand orthosis and highlighted challenges in conducting large randomised controlled trials with this population. Trial Registration: Australia and New Zealand Clinical Trials Registry: U1111-1164-0572 IMPLICATIONS FOR REHABILITATION There may be incremental benefit, for children with cerebral palsy, at 6 and 12 months on passive wrist range from wearing a rigid wrist-hand orthosis designed according to this protocol. The rigid-wrist-hand orthosis evaluated in this study, which allowed for some tailoring for individual children’s presentations, differed in design from past recommendations for “resting hand” positioning. Longitudinal follow up of children with cerebral palsy prescribed a rigid wrist-hand orthosis is essential to monitor any benefit. Minor adverse events were commonly experienced when wearing the orthosis and should be discussed prior to prescription of a rigid wrist-hand orthosis.
AB - Purpose: To investigate the effects of providing rigid wrist-hand orthoses plus usual multidisciplinary care, on reducing hand impairments in children with cerebral palsy. Methods: A pragmatic, multicentre, assessor-blinded randomised controlled trial aimed to enrol 194 children aged 5–15 years, with wrist flexor Modified Ashworth Scale score ≥1. Randomisation with concealed allocation was stratified by study site and passive wrist range. The treatment group received a rigid wrist-hand orthosis, to wear ≥6 h per night for 3 years. Analysis included repeated measures mixed-effects linear regression models, using intention-to-treat principles. Results: The trial stopped early due to insufficient recruitment: 74 children, across all Manual Ability Classification System levels, were randomised (n = 38 orthosis group; n = 36 control). Mean age was 10.2 (SD 3.1) years (orthosis group) and 9.1 (SD 2.8) years (control). Data showed some evidence that rigid wrist-hand orthosis impacted passive wrist extension with fingers extended in the first year [mean difference between-groups at 6 months: 13.15° (95%CI: 0.81–25.48°, p = 0.04); 12 months: 20.94° (95%CI: 8.20–33.69°, p = 0.001)]. Beyond 18 months, participant numbers were insufficient for conclusive findings. Conclusion: The study provided detailed data about short- and long-term effects of the wrist-hand orthosis and highlighted challenges in conducting large randomised controlled trials with this population. Trial Registration: Australia and New Zealand Clinical Trials Registry: U1111-1164-0572 IMPLICATIONS FOR REHABILITATION There may be incremental benefit, for children with cerebral palsy, at 6 and 12 months on passive wrist range from wearing a rigid wrist-hand orthosis designed according to this protocol. The rigid-wrist-hand orthosis evaluated in this study, which allowed for some tailoring for individual children’s presentations, differed in design from past recommendations for “resting hand” positioning. Longitudinal follow up of children with cerebral palsy prescribed a rigid wrist-hand orthosis is essential to monitor any benefit. Minor adverse events were commonly experienced when wearing the orthosis and should be discussed prior to prescription of a rigid wrist-hand orthosis.
KW - Cerebral palsy
KW - child
KW - randomised controlled trial
KW - range of movement
KW - upper limb impairment
UR - http://www.scopus.com/inward/record.url?scp=85131361331&partnerID=8YFLogxK
U2 - 10.1080/09638288.2022.2079734
DO - 10.1080/09638288.2022.2079734
M3 - Article
C2 - 35649128
AN - SCOPUS:85131361331
SN - 0963-8288
VL - 45
SP - 2046
EP - 2056
JO - Disability and Rehabilitation
JF - Disability and Rehabilitation
IS - 12
ER -