A protocol for a single-arm interventional study assessing the effects of a home-based joystick-operated ride-on-toy navigation training programme to improve affected upper extremity function and spontaneous use in children with unilateral cerebral palsy

Introduction: Children with unilateral cerebral palsy (UCP) face significant limitations in upper extremity (UE) function and require effective interventions that promote intensive goal-directed practice while maximising motivation and adherence with therapy. This study builds on our past work and will assess the effects of a 6-week researcher-caregiver codelivered, home-based ride-on-toy navigation training (RNT) programme in young children with UCP. We hypothesise that the RNT programme will be acceptable, feasible to implement, and lead to greater improvements in unimanual and bimanual function when combined with conventional therapy, compared with conventional therapy provided alone.

Methods and analysis: 15 children with UCP between 3 and 8 years will be recruited. During the 6-week control phase, participants will receive treatement-as-usual alone. During the subsequent 6-week intervention phase, in addition to conventional therapy, RNT will be provided 4-5 times/week (2 times by researchers, 2-3 times by caregivers), 30-45 min/session. We will assess UE function using standardised tests (Quality of Upper Extremity Skills Test and Shriner's Hospital Upper Extremity Evaluation), reaching kinematics, wrist-worn accelerometry, caregiver-rated ABILHAND-Kids questionnaire, and training-specific measures of movement control during RNT. Programme feasibility and acceptance will be assessed using device use metrics, child and caregiver exit questionnaires, training-specific measures of child engagement, and the Physical Activity Enjoyment Scale. All assessments will be conducted at pretest, following the control phase (midpoint), and after completion of the intervention phase (post-test).

Ethics and dissemination: The study is approved by the Institutional Review Board of the University of Connecticut (# H22-0059). Results from this study will be disseminated through peer-reviewed manuscripts in scientific journals in the field, through national and international conferences, and through presentations to parent advocacy groups and other support organisations associated with CP.