The effect of novel Head and Trunk Control Rehabilitation (HATCoRe) device in children with cerebral palsy: Single-Subject multiple baseline protocol

Objective: Head and trunk control is essential for enhancing engagement and participation by improving visual integration, respiration, oromotor skill, arm control, and self -care. Our study protocol aims to investigate the effect of novel Head And Trunk Control Rehabilitation (HATCoRe) device on promoting head and trunk control in children with Cerebral Palsy (CP). Method: This single subject multiple baseline design trial will include six children with CP aged two to 10 years, exhibiting delayed head and trunk control, having Gross Motor Function Classification System level IV and V will be enrolled. Participants will be randomly assigned to 4-, 6-, or 8 -weeks baseline phases followed by 16 -week intervention phase with HATCoRe device, for 30- 45 min thrice weekly; and follow-up phase of 9 weeks. The study will span for 29 to 33 weeks. An experienced pediatric physiotherapist, blinded to the baseline duration, will assess the outcome measures through 15 to 19 observations. Structured visual analysis will be used supplemented with the celeration line approach to detect statistically significant change. Impact: HATCoRe device can enable health-care professionals to objectively measure head movement trajectories in children with CP. If proven effective, clinicians may utilize this device to create interactive and child engaging sessions.