Implications of providing wrist-hand orthoses for children with cerebral palsy: evidence from a randomised controlled trial

Abstract

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.

Keywords:

• Cerebral palsy
• child
• randomised controlled trial
• range of movement
• upper limb impairment

Acknowledgements

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.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

Australian Catholic University Research Fund (AP P2013000413) and the NHMRC Centre for Research Excellence – CP Grant (AP P1057997). Additional funding was received from the Perth Children's Hospital Foundation and Monash Health. The trial is registered with the ANZ Clinical Trials Registry (U1111-1164-0572). No funding agency had any role in the data collection, analyses or interpretation.