Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Preschoolers With Bilateral Cerebral Palsy: A Randomized Clinical Trial

Importance Intensive interventions for children with cerebral palsy (CP) have traditionally focused on the upper extremities, despite frequent impairments in gross motor function and the critical period of motor development occurring before age 5 years. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) has demonstrated efficacy in improving manual dexterity and gross motor function in school-aged children, but evidence in preschool children with bilateral CP remains limited. Objective To determine whether early HABIT-ILE improves gross motor function more than usual unstructured motor activities in preschool-aged children with bilateral CP. Design, Setting, and Participants This multicenter randomized clinical trial was conducted between December 2019 and December 2021. Recruitment was from European university hospitals, CP-specialized centers, and spontaneous applications at 4 sites: Brussels, Belgium; Brest and Angers, France; and Pisa, Italy. Children aged 12 to 59 months with spastic or dyskinetic bilateral CP who were able to follow instructions were included. Exclusion criteria were uncontrolled seizures, scheduled botulinum toxin injections or orthopedic surgery during the 6 months before or during the study period, severe visual or cognitive impairments, and contraindications to magnetic resonance imaging. Data were analyzed in May 2024. Interventions Children were randomly assigned (1:1) to receive 2 weeks of usual motor activity, including usual rehabilitation (control group), or 2 weeks (50 hours) of HABIT-ILE (HABIT-ILE group). Main Outcomes and Measures The primary outcome was Gross Motor Function Measure-66 (GMFM-66; range, 0-100, with lower scores indicating lesser gross motor ability). Secondary outcomes included Both Hand Assessment (BoHA), Melbourne Assessment 2, Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), and Canadian Occupational Performance Measure (COPM). Assessments were performed at baseline (immediately before intervention) and 2 weeks and 3 months after baseline. Results Among 49 preschool children with CP (mean [SD] age, 40.18 [11.53] months; 18 girls [36.7%] and 31 boys [63.3%]), Gross Motor Function Classification levels were I in 5 children, II in 14 children, III in 17 children, and IV or V in 13 children and Mini-Manual Ability Classification levels were I in 10 children, II in 27 children, III in 7 children, and IV or V in 6 children. Change in mean (SD) GMFM-66 score from baseline to 3 months was significantly greater in the HABIT-ILE group (5.01 [2.52] logits) than the control group (0.70 [1.98] logits) (adjusted mean difference [aMD] in score, 4.33 logits; 95% CI, 3.03-5.62 logits; P < .001). Likewise, mean (SD) scores favored the HABIT-ILE group vs the control group for secondary outcomes of BoHA (5.32 [4.47] vs 0.13 [5.16]; aMD, 5.15; 95% CI, 2.23-8.08; P < .001), PEDI-CAT mobility domain (1.70 [2.18] vs −0.40 [4.38]; aMD, 2.27; 95% CI, 0.20-4.33; P = .03), and COPM performance (4.22 [1.61] vs 1.14 [1.35]; aMD, 3.55; 95% CI, 2.86-4.24; P < .001) and satisfaction (4.37 [1.38] vs 1.15 [1.63]; aMD, 3.11; 95% CI, 2.25-3.97; P < .001). Conclusions and Relevance In this randomized clinical trial, early HABIT-ILE significantly improved upper and lower extremities motor performance in preschool-aged children with bilateral CP at 3 months after the intervention. These findings suggest that HABIT-ILE is effective in improving gross motor function in preschool-aged children with bilateral CP. Trial Registration Clinicaltrial.gov Identifier: NCT04020354