Randomized comparison trial of rehabilitation very early for infants with congenital hemiplegia

Journal article

Boyd, Roslyn N., Greaves, Susan, Ziviani, Jenny, Novak, Iona, Badawi, Nadia, Pannek, Kerstin, Elliott, Catherine, Wallen, Margaret, Morgan, Catherine, Valentine, Jane, Findlay, Lisa, Guzzetta, Andrea, Whittingham, Koa, Ware, Robert S., Fiori, Simona, Maitre, Nathalie L., Heathcock, Jill, Scott, Kimberley, Eliasson, Ann-Christin and Sakzewski, Leanne. (2025). Randomized comparison trial of rehabilitation very early for infants with congenital hemiplegia. Journal of Pediatrics. 277, p. Article 114381. https://doi.org/10.1016/j.jpeds.2024.114381
AuthorsBoyd, Roslyn N., Greaves, Susan, Ziviani, Jenny, Novak, Iona, Badawi, Nadia, Pannek, Kerstin, Elliott, Catherine, Wallen, Margaret, Morgan, Catherine, Valentine, Jane, Findlay, Lisa, Guzzetta, Andrea, Whittingham, Koa, Ware, Robert S., Fiori, Simona, Maitre, Nathalie L., Heathcock, Jill, Scott, Kimberley, Eliasson, Ann-Christin and Sakzewski, Leanne
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.

Year2025
JournalJournal of Pediatrics
Journal citation277, p. Article 114381
PublisherElsevier Inc.
ISSN0022-3476
Digital Object Identifier (DOI)https://doi.org/10.1016/j.jpeds.2024.114381
PubMed ID39477009
Scopus EID2-s2.0-85209555495
Open accessPublished as ‘gold’ (paid) open access
Page range1-13
FunderNational Health and Medical Research Council (NHMRC)
Swedish Research Council
Stockholm City Council
Foundation Olle Engkvist Byggmästare
Foundation Frimurarna Barnhuset
Publisher's version
License
File Access Level
Open
Output statusPublished
Publication dates
Online22 Nov 2024
Publication process dates
Accepted23 Oct 2024
Deposited09 May 2025
Additional information

© 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

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