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

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