Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in Infants With Unilateral Cerebral Palsy: A Randomized Clinical Trial.

Importance: Earlier detection of cerebral palsy (CP) and the high neuroplastic potential during the first years of life have motivated a search for early interventions to improve children's long-term motor abilities. Objective: To determine the effectiveness of baby Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) to improve motor function in infants with unilateral CP (UCP). Design, Setting, and Participants: This parallel group, 1:1, randomized clinical trial was conducted between December 1, 2020, and September 9, 2022, in infants recruited through centers specializing in CP treatment and parents' spontaneous applications. Therapy took place in Brussels, Belgium, from March 8, 2021, through June 17, 2022. Infants were matched in pairs by age and lesion type and randomized to either the treatment or control group. Infants were assessed at baseline (T0) and 1 (T1) and 3 months (T2) follow-up. Inclusion criteria were aged 6 to 18 months at T0 (corrected age if preterm birth), a diagnosis or being at risk of UCP, and the ability to comply with the testing and training procedures. Exclusion criteria were uncontrolled seizures, botulinum toxin injections, orthopedic surgery, or specific intensive therapy within 6 months before and until the end of the study. Intervention: Infants in the treatment group received 50 hours of baby HABIT-ILE over 2 weeks, while those in the control group continued their usual motor activities. Main Outcomes and Measures: The primary outcome was use of the more affected hand as measured using the Mini-Assisting Hand Assessment (Mini-AHA). Secondary outcomes included Canadian Occupational Performance Measure (COPM) performance and satisfaction scores, Gross Motor Function Measure-66 (GMFM-66) scores, and other motor and functional outcomes. Between-group comparisons were calculated using repeated-measures analysis of variance (2 groups × 3 assessment times). Effect sizes were reported as partial η squared (ηp2) (small, 0.01; medium, 0.06; large, 0.14). Results: Of the 48 infants entering the study, 46 (mean [SD] age, 13.3 [4.1] months; 27 boys [58%]) were included in the final analyses, with 24 in the treatment group and 22 in the control group. Group × assessment time interactions showed significant improvements that favored the treatment group for the Mini-AHA (mean [SE] difference from T0 to T2, 7.4 [1.4] Mini-AHA units in the treatment group vs 1.9 [1.5] Mini-AHA units in the control group; P = .008; ƞp2 = 0.11) and for both parts of the COPM (mean [SE] difference from T0 to T2, 5.0 [0.4] in the treatment group vs 2.9 [0.4] in the control group; P < .001; ƞp2 = 0.35 for the performance score and 4.4 [0.4] in the treatment group vs 2.1 [0.4] in the control group; P < .001; ƞp2 = 0.33 for the satisfaction score). Although both groups improved in the GMFM-66 (mean [SE] difference from T0 to T2, 6.6% [0.7%] logits in the treatment group vs 5.5% [0.7%] logits in the control group; P < .001; ηp2 = 0.68), there was no significant interaction (P = .43; ηp2 = 0.02). Conclusions and Relevance: This randomized clinical trial demonstrates the feasibility of delivering 50 hours of HABIT-ILE over a 2-week period in infants with UCP. These findings show that the intervention is effective in improving motor abilities, as revealed by an increase in the use of the more affected hand in bimanual tasks and in enhanced reported functional goal outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT04698395.