Randomized Comparison Trial of Rehabilitation Very Early for Infants with Congenital Hemiplegia

Abstract

Objective: To compare efficacy of constraint-induced movement therapy (Baby-CIMT) with bimanual therapy (Baby-BIM) in infants at high risk of unilateral cerebral palsy.; Study Design: This was a single-blind, randomized-comparison-trial that had the following inclusion criteria: (1) asymmetric brain lesion (2) absent fidgety General Movements, (3) Hammersmith Infant Neurological Examination below cerebral palsy cut-points, (4) entry at 3-9 months of corrected age, and (5) >3-point difference between hands on Hand Assessment Infants (HAI). Infants were randomized to Baby-CIMT or Baby-BIM, which comprised 6-9 months of home-based intervention. Daily dose varied from 20 to 40 minutes according to age (total 70-89.2 hours). Primary outcome measure was the HAI after intervention, with secondary outcomes Mini-Assisting Hand Assessment and Bayley III cognition at 24 months of corrected age.; Results: In total, 96 infants (51 male, 52 right hemiplegia) born median at 37-weeks of gestation were randomized to Baby-CIMT (n = 46) or Baby-BIM (n = 50) and commenced intervention at a mean 6.5 (SD 1.6) months corrected age. There were no between group differences immediately after intervention on HAI (mean difference [MD] 0.98 HAI units, 95% CI 0.94-2.91; P = .31). Both groups demonstrated significant clinically important improvements from baseline to after intervention (Baby-BIM MD 3.48, 95% CI 2.09-4.87; Baby-CIMT MD 4.42, 95% CI 3.07-5.77). At 24 months, 64 infants were diagnosed with unilateral cerebral palsy (35 Baby-CIMT, 29 Baby-BIM). Infants who entered the study between 3 and 6 months of corrected age had greater change in HAI Both Hands Sum Score compared with those who entered at ≥6 months of corrected age (MD 7.17, 95% CI 2.93-11.41, P = .001).; Conclusions: Baby-CIMT was not superior to Baby-BIM, and both interventions improved hand development. Infants commencing intervention at <6 months corrected age had greater improvements in hand function.; Competing Interests: Declaration of Competing Interest This study is funded by the Australian National Health and Medical Research Council (NHMRC project grant no. 1078877). The NHMRC has provided people support for the following team members: a Research Fellowship (RB, 1105038) Early Career Fellowship (KW, 631712). ACE was supported by Swedish Research Council (grant nos. 521-211-2655 and 521-2011-456), Stockholm City Council (2011-2117), Foundation Olle Engkvist Byggmästare and Foundation Frimurarna Barnhuset. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)