Background/Objectives: Pediatric acquired brain injury (ABI) frequently produces persistent motor, cognitive and psychosocial deficits that impair quality of life (QoL), participation and physical activity. Multidimensional interventions aligned with the International Classification of Functioning, Disability and Health (ICF) framework are required. Sport-based interventions. when adapted to developmental stages and individual preferences, may enhance motivation, peer interaction and sustained participation, yet standardized protocols for pediatric ABI are scarce. This study describes a randomized controlled trial protocol evaluating the effectiveness of a 16-week sport-based exercise program designed for adolescents with ABI.
Methods: This two-arm parallel trial (ClinicalTrials.gov NCT06804486) follows SPIRIT and CONSORT guidelines and received approval from the Regional Ethics Committee of Madrid (EC 33.25). Ninety adolescents (11–17 years) with a subacute or chronic ABI will be recruited at Hospital Niño Jesús (Madrid, Spain). Eligibility requires confirmed ABI, the ability to follow simple instructions and the absence of medical contraindications for exercise. Participants will be allocated 1:1 by centralized, computer-generated stratified block randomization (strata: age group); allocation concealment will be ensured by an independent statistician. The experimental arm will receive supervised sport-based sessions (60 min, twice weekly for 16 weeks) plus usual care; the control arm will receive usual care alone. Outcome assessors will be blinded. Treatment fidelity will be ensured by a manualized protocol, provider training, session fidelity checklists, attendance logs and biweekly follow-up calls. Primary outcomes (pre/post) are QoL (PedsQL), participation (CASP), physical activity (GPAQ) and motor proficiency (BOT-2). Analysis follows intention-to-treat principles; mixed-effects models will test group×time effects with adjustment for baseline covariates. Sample size: n = 90 (45 per group). Calculation will be based on PedsQL variability (SD ≈10), α=0.05, power=80%, with a 15% attrition adjustment (see manuscript for details).
Discussion: The trial tests a pragmatic, reproducible sport-based model bridging clinical rehabilitation and community participation, integrating motor and psychosocial targets to promote sustainable engagement in adolescents with ABI.
