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- Title
Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial.
- Authors
Araneda, Rodrigo; Ebner-Karestinos, Daniela; Paradis, Julie; Klöcker, Anne; Saussez, Geoffroy; Demas, Josselin; Bailly, Rodolphe; Bouvier, Sandra; Carton de Tournai, Astrid; Herman, Enimie; Souki, Aghiles; Le Gal, Grégoire; Nowak, Emmanuel; Sizonenko, Stephane V.; Newman, Christopher J.; Dinomais, Mickael; Riquelme, Inmaculada; Guzzetta, Andrea; Brochard, Sylvain; Bleyenheuft, Yannick
- Abstract
This study attempts to verify if Hand-Arm Bimanual Intensive Therapy Including Lower Extremities would improve manual abilities in young children with unilateral cerebral palsy more than usual motor activity. Key Points: Question: What is the effect of early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) intervention on bimanual performance vs usual, unstructured spontaneous motor activity in children between 1 and 4 years old with unilateral cerebral palsy after 3 months? Findings: This randomized clinical trial including 50 children found improvements in bimanual hand function scores that were significantly higher in the HABIT-ILE group than in the control group. Meaning: Early HABIT-ILE improved bimanual performance more than usual motor activity in young children with unilateral cerebral palsy. Importance: Intensive interventions are provided to young children with unilateral cerebral palsy (UCP), classically focused on the upper extremity despite the frequent impairment of gross motor function. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) effectively improves manual dexterity and gross motor function in school-aged children. Objective: To verify if HABIT-ILE would improve manual abilities in young children with UCP more than usual motor activity. Design, Setting, and Participants: This prospective randomized clinical trial (November 2018 to December 2021), including 2 parallel groups and a 1:1 allocation, recruitment took place at European university hospitals, cerebral palsy specialized centers, and spontaneous applications at 3 sites: Brussels, Belgium; Brest, France; and Pisa, Italy. Matched (age at inclusion, lesion type, cause of cerebral palsy, and affected side) pairs randomization was performed. Young children were assessed at baseline (T0), 2 weeks after baseline (T1), and 3 months after baseline (T2). Health care professionals and assessors of main outcomes were blinded to group allocation. At least 23 young children (in each group) aged 12 to 59 months with spastic/dyskinetic UCP and able to follow instructions were needed. Exclusion criteria included uncontrolled seizures, scheduled botulinum toxin injections, orthopedic surgery scheduled during the 6 months before or during the study period, severe visual/cognitive impairments, or contraindications to magnetic resonance imaging. Interventions: Two weeks of usual motor activity including usual rehabilitation (control group) vs 2 weeks (50 hours) of HABIT-ILE (HABIT-ILE group). Main Outcomes and Measures: Primary outcome: Assisting Hand Assessment (AHA); secondary outcomes: Gross Motor Function Measure-66 (GMFM-66), Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), and Canadian Occupational Performance Measure (COPM). Results: Of 50 recruited young children (26 girls [52%], median age; 35.3 months for HABIT-ILE group; median age, 32.8 months for control group), 49 were included in the final analyses. Change in AHA score from T0 to T2 was significantly greater in the HABIT-ILE group (adjusted mean score difference [MD], 5.19; 95% CI, 2.84-7.55; P <.001). Changes in GMFM-66 (MD, 4.72; 95% CI, 2.66-6.78), PEDI-CAT daily activities (MD, 1.40; 95% CI, 0.29-2.51), COPM performance (MD, 3.62; 95% CI, 2.91-4.32), and satisfaction (MD, 3.53; 95% CI, 2.70-4.36) scores were greater in the HABIT ILE group. Conclusions and Relevance: In this clinical trial, early HABIT-ILE was shown to be an effective treatment to improve motor performance in young children with UCP. Moreover, the improvements had an impact on daily life activities of these children. Trial registration: ClinicalTrials.gov Identifier: NCT04020354
- Subjects
CEREBRAL palsy treatment; PHYSIOLOGY of the anatomical extremities; CONFIDENCE intervals; ACTIVITIES of daily living; TREATMENT effectiveness; RANDOMIZED controlled trials; T-test (Statistics); MANIPULATION therapy; DESCRIPTIVE statistics; RESEARCH funding; STATISTICAL sampling; DATA analysis software; MOTOR ability; LONGITUDINAL method; CHILDREN
- Publication
JAMA Pediatrics, 2024, Vol 178, Issue 1, p19
- ISSN
2168-6203
- Publication type
Article
- DOI
10.1001/jamapediatrics.2023.4809