Pressure garment therapy and bimanual upper limb function in children with unilateral cerebral palsy: A randomized clinical trial.

AIM: To assess the effects of pressure garment therapy (PGT) using a compressive Lycra sleeve on bimanual function in a large sample of children with unilateral cerebral palsy (CP). METHODS: This multicentre, randomized, double-blind placebo-controlled clinical trial was conducted over 6 months. Children with unilateral CP were recruited across seven French rehabilitation centres between 2013 and 2020. Children were randomly assigned to receive either the active PGT sleeve or a placebo PGT sleeve. The primary outcome was bimanual function, assessed by the Assisting Hand Assessment (AHA) score at 6 months. Secondary outcomes included the Quality of Upper Extremity Skills Test score, quality of life, neuro-orthopaedic examination results, and somatosensory evoked potentials (SEPs). RESULTS: A total of 101 children were randomized (mean age [standard deviation] 7 years 1 month [1 year 6 months]). At 6 months, the AHA scores did not differ between groups (PGT 57.62 [0.97] vs placebo 57.63 [0.87]; mean difference - 0.01 AHA units [p = 0.99]). There were no significant differences in any of the SEP parameters measuring upper arm nerve function between the two groups. For example, the mean difference in interside latency/amplitude for N9 SEPs was PGT 0.50 (0.09) versus placebo 0.50 (0.10); mean difference - 0.01 (p = 0.96). INTERPRETATION: These findings suggest that this form of PGT using a compressive dynamic Lycra sleeve (4 hours/day over 6 months at 15-25 mmHg) does not provide clinically meaningful improvements in bimanual function or neurophysiological outcomes in children with unilateral CP. This suggests limited clinical use for this intervention in routine rehabilitation practice.