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

Abstract

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.

The Role of Immersive Virtual Reality Interventions in Pediatric Cerebral Palsy: A Systematic Review across Motor and Cognitive Domains

“…The feasibility, effectiveness, and significant non-inferiority of VR treatment compared to non-VR treatment were confirmed by Saussez et al [36] in an RCT where 40 children with hemiparetic CP (20 in the experimental group, undergoing HABIT-ILE therapy in association with semi-immersive virtual reality (REAtouch), and 20 in the control group, undergoing therapy only with HABIT-ILE, showed significant improvements in gross motor function and ambulation. The REAtouch intervention showed significant improvements in the less affected hand, while the HABIT-ILE intervention showed significant improvements in the more affected hand.…”

“…Our review demonstrates how immersive VR can be used in children with CP for a wide range of outcomes: motor (large motor, posture and walking, dexterity, symmetry of bimanual movements) and cognitive (visuo-spatial skills, planning skills, perceptual organization, visuo-motor coordination and self-control, rather than visuospatial memory), as well as non-cognitive/non-motor outcomes such as composition, such as increase in height, lean mass, and skeletal muscle mass [23][24][25][26][27][28][29][30][31][32][33][34][35][36].…”

“…The methodological quality of the included studies varied, with total scores ranging from 4 to 7. While some studies achieved relatively high scores [23][24][25][26][27][31][32][33][34][35][36], indicating good methodological rigor, others scored lower [28][29][30]37], suggesting potential limitations in study design or execution. Overall, the quality of evidence across the reviewed studies appears to be moderate to good, with most studies demonstrating satisfactory methodological quality according to the NOS criteria [22].…”

“…Compared to typically developing children, those with CP exhibited decreased walking speed and step length, decreased peak hip abduction moment, increased static phase percentage, increased ankle dorsiflexion peak and knee flexion, and increased peak hip extension moment. Unlike previous studies, the virtual rehabilitation system CAREN+ was also used in the study by Barton et al [28], demonstrating no significant inferiority of VR treatment compared to non-VR treatment, as demonstrated by Saussez et al [36].…”