Study protocol for Full Speed Ahead: an intervention for improved activities in daily life through Frame Running and Goal directed training.

Abstract

Background: Early and intensive intervention is crucial for children with cerebral palsy (CP), particularly during the period when gross motor activities typically develop. Despite the prevalence of CP, robust evidence for effective early mobility interventions remains limited. Frame Running, which enables children with limited walking ability to engage in dynamic, high-intensity activities, has emerged as a promising approach, yet research on its effect in young children is currently lacking. The aim of this study is to implement and evaluate the effects of a mobility-focused training program combining Frame Running and goal-directed gross motor training, on mobility in every day life and cardiovascular health in children aged 2-5 years with CP.

Method: The study uses a prospective repeated-measures intervention design with assessments conducted during baseline, intervention, and post-intervention follow-up phases. At least 18 children meeting the inclusion criteria (CP diagnosis, age 2-5 years, GMFCS II-IV) will participate. The design consists of three baseline measurements, a 12-week intervention phase and three post-intervention measurements, across approximately 5-6 months. The program combines home-based training and hospital-based group training, with parents as active trainers and therapists providing coaching. Frame Running and goal-directed training are tailored to individual goals, set collaboratively with families. Outcome measures include the Gross Motor Function Measure (GMFM-66), Functional Mobility Scale (FMS), Paediatric Evaluation of Disability Inventory Computerised Assessment Test (PEDI-CAT), time-based mobility tests: ultrasound assessment of muscle size and morphology, gait analysis, accelerometry (7-day activity monitoring), heart rate monitoring during training, and Goal Attainment Scaling (GAS). Feasibility and fidelity will be investigated by questionnaires.

Discussion: By evaluating the Full Speed Ahead program, this study aims to improve understanding of how an early intensive family-centered mobility intervention may influence developmental trajectories and health in children with CP. If effective, the findings will have significant implications for planning both short- and long-term treatment and services for young children with CP. The prospective repeated-measures intervention design allows for both group-level and individual-level analysis of changes over time, thereby strengthening the evidence base for early, intensive, family-centered mobility interventions.

Trial registration: ClinicalTrial.gov NCTO7374432, Registered November 18 2025.