Efficacy of integrating a semi-immersive virtual device in the HABIT-ILE intervention for children with unilateral cerebral palsy: a non-inferiority randomized controlled trial.

BACKGROUND

The implementation of virtual devices can facilitate the role of therapists (e.g., patient motivation, intensity of practice) to improve the effectiveness of treatment for children with cerebral palsy. Among existing therapeutic devices, none has been specifically designed to promote the application of principles underlying evidence-based motor skill learning interventions. Consequently, evidence is lacking regarding the effectiveness of virtual-based sessions in motor function rehabilitation with respect to promoting the transfer of motor improvements into daily life activities. We tested the effectiveness of implementing a recently developed virtual device (REAtouch), specifically designed to enable the application of therapeutic motor skill learning principles, during a Hand Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) intervention.

METHODS

Forty children with unilateral cerebral palsy (5-18 years; MACS I-III; GMFCS I-II) were randomly assigned to a control group or a "REAtouch" experimental group for a 90-h HABIT-ILE day-camp intervention (two weeks). Children in the REAtouch group spent nearly half of their one-on-one therapeutic time using the REAtouch. Participants underwent three testing sessions: the week before (T1), after intervention (T2), and at three months follow-up (T3). The primary outcome was the Assisting Hand Assessment (T3-T1; blinded). Secondary outcomes measured uni-bimanual hand function, stereognosis, gait endurance, daily life abilities, and functional goals. Accelerometers and a manual report of daily activities served to document therapeutic dosage and treatment characteristics. We used one-way RMANOVA to compare the efficacies of the two interventions, and non-inferiority analyses to contrast changes in the "REAtouch" group versus the "HABIT-ILE" control group.

RESULTS

We found significant improvements in both groups for most of the outcome measures (p < 0.05). There was significant non-inferiority of changes in the REAtouch group for upper extremities motor function, functional goals attainment, and abilities in daily life activities (p < 0.05).

CONCLUSIONS

Use of the REAtouch device during HABIT-ILE showed non-inferior efficacy compared to the conventional evidence-based HABIT-ILE intervention in children with unilateral cerebral palsy. This study demonstrates the feasibility of using this virtual device in a high dosage camp model, and establishes the possibility of applying the therapeutic principles of motor skill learning during specifically designed virtual-based sessions.

TRIAL REGISTRATION

Trial registration number: NCT03930836-Registration date on the International Clinical Trials Registry Platform (ICTRP): June 21th, 2018; Registration date on NIH Clinical Trials Registry: April 29th, 2019. First patient enrollment: July 3rd, 2018.