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

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: r.boyd@uq.edu.au.
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

Randomized Controlled Trial

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

Roslyn N Boyd et al. J Pediatr. 2025 Feb.

. 2025 Feb:277:114381.

doi: 10.1016/j.jpeds.2024.114381. Epub 2024 Oct 29.

Authors

Affiliations

¹ Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Queensland, Australia. Electronic address: r.boyd@uq.edu.au.
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.

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Conflict of interest statement

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.

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

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LinkOut - more resources

Medical