HABIT-ILE@home for Children With Bilateral Cerebral Palsy: Protocol for Noninferiority and Superiority Randomized Controlled Trials.

Cerebral palsy (CP) represents the most prevalent cause of physical disability in the pediatric population, affecting 1 to nearly 4 children in 1000 newborns worldwide [,]. This major public health problem, caused by abnormalities in or damage to brain development, results in a range of symptoms that vary widely from child to child. While all children with CP will develop motor symptoms such as postural and movement control deficits, some will also develop additional nonmotor symptoms, including pain (75%), intellectual deficits (50%), language disorders (25%), epilepsy (25%), and behavioral and sleep disorders (20%‐25%) []. The consequences of these symptoms may vary in severity but are typically manifested as long-term functional limitations in daily activities, including dressing, eating, and personal hygiene []. To enhance individual motor function and functional performance, intensive therapies based on motor skill learning (MSL) have been demonstrated to be particularly efficacious []. Among these interventions, Hand-Arm Bimanual Intensive Therapy including Lower Extremities (HABIT-ILE) has been developed over the last decade with the purpose to simultaneously engage upper and lower extremities as well as trunk control through bimanual manipulative activities performed while sitting on a ball, standing, or walking []. HABIT-ILE has led to notable improvements in upper and lower extremity functions, as well as in bimanual performance and activities of daily living for children with bilateral and unilateral CP [,]. A previous study [] has shown that upper extremity improvement was not attenuated by the simultaneous engagement of both the upper and lower extremities compared to a similar intervention solely focusing on the upper extremities. In addition, the HABIT-ILE approach has been demonstrated to facilitate significant enhancements in social participation and a reduction in mirror movements among children with unilateral CP []. The motor and functional improvements observed following HABIT-ILE seem to be linked to changes in cerebral activity, as evidenced by changes in the fronto-parietal and cerebellum networks, as well as in the integrity of corticospinal tract fibers [,]. The intervention is typically delivered as a 2-week rehabilitation camp, comprising 50 to 90 hours of on-site activities [-]. However, this mode of delivery raises limitations in terms of accessibility and scalability. The implementation of a 2-week day camp necessitates considerable commitment from families, who frequently must travel to reach the therapy site. As the number of locations offering HABIT-ILE therapy is currently limited, families who live a long way from the facility and who are unable to travel cannot benefit from this therapy. Moreover, the organization of such intensive therapies continues to represent a significant challenge, given the necessity for a relatively spacious training room, a substantial quantity of equipment, and the involvement of trained therapists []. To address these concerns, the introduction of a home-based HABIT-ILE telerehabilitation program combined with caregiver coaching may represent an alternative solution. Virtual devices may be an effective means of implementing MSL principles and facilitating remote communication with families []. The range of telerehabilitation devices is vast, from classic video games [] to devices specifically designed for rehabilitation purposes [-]. Although not all devices appear equally effective in implementing all principles of MSL during virtual-based-interventions, these principles can be applied with specifically-designed devices and the supervision of a trained therapist [].