Efficacy of Integrating the Interactive Virtual Device (REAtouch®) into HABIT-ILE for Children with Bilateral Cerebral Palsy: A Randomized Controlled Non-Inferiority Trial.

BACKGROUND: Implementing intensive motor skill learning interventions like Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in clinical practice faces accessibility challenges. Integrating the interactive virtual device (REAtouch®) into HABIT-ILE may help overcome these barriers, with potential for remote use. OBJECTIVE: This study aimed to investigate whether HABIT-ILE with REAtouch® has non-inferior results compared to usual HABIT-ILE in children with bilateral cerebral palsy (BCP). METHODS: Thirty children with BCP were randomized into the REAtouch® group (using the device for half of the one-to-one intervention time) or the HABIT-ILE group. Both groups completed a 65-hour intervention over 2 weeks. Assessments were conducted at baseline, post-intervention, and follow-up using primary (Gross Motor Function Measure [GMFM-66] and ABILHAND-Kids) and secondary measures. Analyses included one-way RM ANOVA, Friedman Test, and non-inferiority statistics. RESULTS: Non-inferiority analysis indicated that the REAtouch® group did not achieve non-inferior changes compared with usual HABIT-ILE for most primary and secondary outcomes at post-intervention and follow-up (p > 0.025). Although both groups demonstrated statistically significant improvements in primary and most secondary outcomes, non-inferiority was confirmed only for ABILHAND-Kids (P = .022) and JTTHF-MA (P = 0.021) at post-intervention. CONCLUSION: While both groups improved in motor functions and daily life abilities, integrating REAtouch® into HABIT-ILE may not allow achieving non-inferior changes compared to usual HABIT-ILE in children with BCP. This highlights the role of virtual devices like REAtouch® as complementary tools rather than replacements for evidence-based therapy, with potential to enhance accessibility through carefully implemented remote use. CLINICAL TRIAL REGISTRATION NUMBER: NCT04403464.