Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in adults with chronic stroke: a randomized controlled trial

BACKGROUND: Stroke rehabilitation guidelines recommend goal-oriented, task-specific, intensive interventions. Yet most programs emphasize upper extremity (UE) recovery, overlooking lower extremities (LEs) and trunk, which are essential for activities of daily living. Consequently, Hand-Arm Bimanual Intensive Therapy Including LEs (HABIT-ILE) represents a promising approach for stroke rehabilitation. OBJECTIVE: This randomized controlled trial aimed to determine the effect of HABIT-ILE and to compare its efficacy with a control group in adults with chronic hemiparetic stroke by promoting greater improvements across the body functions, activity, and participation domains of the International Classification of Functioning, Disability and Health. METHODS: Forty-six adults with hemiparetic chronic stroke were randomized to either a 2-week (50 h, 5 h/day) HABIT-ILE camp-setting program in Brussels, Belgium, or to continue their usual neurorehabilitation (mean = 4 h 36 min) for over the same period. Participants were assessed before, immediately, and at 3 months after intervention using the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke, primary outcome), the Canadian Occupational Performance Measure (COPM), the Fugl Meyer Assessment for UEs (FMA-UE), the Wolf Motor Function Test (WMFT), the ABILHAND-CS and ACTIVLIM-CS questionnaires, the six-minute walk test, the modified Rankin Scale and the Stroke Impact Scale (SIS). RESULTS: The ANCOVA revealed a significant between-groups difference favoring the HABIT-ILE group (TG), with a time effect observed for the Ad-AHA Stroke (TG: at 2 weeks = +6.24% of logits; at 3 months = +7.05% of logits), WMFT (Functional Ability Scale, all P ≤ 0.041), and COPM (P < 0.001, performance and satisfaction) at both 2 weeks and 3 months. We found a similar significant effect for the SIS (hand function, P = 0.003) at 2 weeks and the FMA-UE and ABILHAND-CS at 3 months (all P ≤ 0.033). We observed no significant between-group differences for the other outcomes, including LEs measures. CONCLUSION: In adults with chronic stroke, HABIT-ILE intervention significantly improved spontaneous bimanual use, motor function, and ability of the paretic UE (both externally rated and self-perceived) and reduced participation restrictions compared with the control group. TRIAL REGISTRATION: This randomized controlled trial was registered on December 11th, 2020, on ClinicalTrials.gov as "HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)", with the registration number NCT04664673 (https://clinicaltrials.gov/study/NCT04664673?cond=NCT04664673&rank=).