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

Roslyn N Boyd; Susan Greaves; Jenny Ziviani; Iona Novak; Nadia Badawi; Kerstin Pannek; Catherine Elliott; Margaret Wallen; Catherine Morgan; Jane Valentine; Lisa Findlay; Andrea Guzzetta; Koa Whittingham; Robert S Ware; Simona Fiori; Nathalie L Maitre; Jill Heathcock; Kimberley Scott; Ann-Christin Eliasson; Leanne Sakzewski

doi:10.1016/j.jpeds.2024.114381

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

J Pediatr. 2024 Oct 29:277:114381. doi: 10.1016/j.jpeds.2024.114381. Online ahead of print.

Authors

Roslyn N Boyd¹, Susan Greaves², Jenny Ziviani³, Iona Novak⁴, Nadia Badawi⁵, Kerstin Pannek⁶, Catherine Elliott⁷, Margaret Wallen⁸, Catherine Morgan⁵, Jane Valentine⁹, Lisa Findlay¹⁰, Andrea Guzzetta¹¹, Koa Whittingham¹², Robert S Ware¹³, Simona Fiori¹¹, Nathalie L Maitre¹⁴, Jill Heathcock¹⁵, Kimberley Scott¹⁵, Ann-Christin Eliasson¹⁶, Leanne Sakzewski¹²

Affiliations

¹ Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Queensland, Australia. Electronic address: [email protected].
² Department of Occupational Therapy, Royal Children's Hospital, Melbourne, Victoria, Australia.
³ Queensland Paediatric Rehabilitation Service, Children's Health Queensland, Brisbane, Queensland, Australia; School of Health and Rehabilitation Sciences, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.
⁴ Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Cerebral Palsy Alliance Research Institute, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, Australia.
⁵ Cerebral Palsy Alliance Research Institute, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, Australia.
⁶ The Australian E-Health Research Centre, CSIRO, Brisbane, Queensland, Australia.
⁷ Curtin University, School of Occupational Therapy and Social Work, Perth, Australia; Department of Rehabilitation, Perth Children's Hospital, Perth, Western Australia, Australia.
⁸ School of Allied Health, Australian Catholic University, North Sydney, Australia.
⁹ Department of Rehabilitation, Perth Children's Hospital, Perth, Western Australia, Australia.
¹⁰ Queensland Paediatric Rehabilitation Service, Children's Health Queensland, Brisbane, Queensland, Australia.
¹¹ Stella Maris Infant Lab for Early Intervention (SMILE), IRCCS Stella Maris and The University of Pisa, Pisa, Italy.
¹² Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Queensland, Australia.
¹³ Menzies Health Institute Queensland, Griffith University Gold Coast, Southport, Queensland, Australia.
¹⁴ Biostatistics, Emory University and Children's Healthcare of Atlanta, Atlanta, GA.
¹⁵ Division of Physical Therapy, The Ohio State University, Columbus, OH.
¹⁶ Neuropediatric Unit, Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.

PMID: 39477009
DOI: 10.1016/j.jpeds.2024.114381

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.