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Randomized Controlled Trial
. 2024 Jan 1;178(1):19-28.
doi: 10.1001/jamapediatrics.2023.4809.

Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial

Rodrigo Araneda  1   2 , Daniela Ebner-Karestinos  1   2 , Julie Paradis  3 , Anne Klöcker  4 , Geoffroy Saussez  1   5 , Josselin Demas  6   7 , Rodolphe Bailly  8   9 , Sandra Bouvier  9   10 , Astrid Carton de Tournai  1 , Enimie Herman  1 , Aghiles Souki  11 , Grégoire Le Gal  11   12 , Emmanuel Nowak  11   12 , Stephane V Sizonenko  13 , Christopher J Newman  14 , Mickael Dinomais  6   15 , Inmaculada Riquelme  16 , Andrea Guzzetta  3   17 , Sylvain Brochard  8   9   10   11 , Yannick Bleyenheuft  1
Affiliations
Randomized Controlled Trial

Changes Induced by Early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Young Children With Unilateral Cerebral Palsy: A Randomized Clinical Trial

Rodrigo Araneda et al. JAMA Pediatr. .

Erratum in

  • Errors in Abstract and Author Name.
    [No authors listed] [No authors listed] JAMA Pediatr. 2024 Feb 1;178(2):206. doi: 10.1001/jamapediatrics.2023.6170. JAMA Pediatr. 2024. PMID: 38109107 Free PMC article. No abstract available.

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Araneda reported grants from the Fondation Paralysie Cerebrale. Dr Paradis reported grants from the Marguerite-Marie Delacroix Foundation during the conduct of the study. Dr Saussez reported grants from the Fund for Scientific Research-Fund for Research Training in Industry and Agriculture during the conduct of the study. Dr Le Gal reported grants from Pfizer and Myers Squibb and personal fees from Pfizer, Sanofi, and Aspen Pharmacies outside the submitted work. Dr Nowak reported grants from the Fondation de France paid to their organization during the conduct of the study. Dr Sizonenko reported grants from the Fondation Paralysie Cérébrale during the conduct of the study. Dr Dinomais reported grants from La Fondation Paralysie Cérébrale during the conduct of the study. Dr Guzzetta reported grants from the Fondation Paralysie Cerebral HABIT-ILE and the Italian Ministry of Health RC Linea 1 during the conduct of the study and grants from Horizon outside the submitted work. Dr Brochard reported grants from La fondation Paralysie Cérébrale during the conduct of the study. Dr Bleyenheuft reported grants from the Fondation Paralysie Cérébrale for this research project allocated after selection by a scientific committee during the conduct of the study, grants from the Fondation JED Belgique, Biowin, and Actions de Recherches Concertées/Université catholique de Louvainbrain outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Diagram of Participants
HABIT-ILE indicates Hand-Arm Bimanual Intensive Therapy Including Lower Extremities; T0, first testing session (baseline); T1, second testing session 2 weeks after T0; T2, third testing session 3 months after T0.
Figure 2.
Figure 2.. Changes in Motor and Functional Goals After Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) Training
Blue dots indicate the mean of the treatment group (HABIT-ILE); orange dots indicate mean of the control group. For all dots, the whiskers represent the standard error. AHA indicates Assisting Hand Assessment; COPM, Canadian Occupational Performance Measure; GMFM, Gross Motor Function Measure; T0, first testing session (baseline); T1, second testing session 2 weeks after T0; T2, third testing session 3 months after T0.
See this image and copyright information in PMC

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