Abstract
Abstract
Background
Maintaining and improving motor function is essential in the rehabilitation of children with cerebral palsy (CP). Stretching is traditionally used to prevent muscle tightness and contractures to improve movement patterns in children with CP. Fascial manipulation (FM) is an increasingly used manual therapy method for movement difficulties associated with CP. However, evidence for FM remains limited, and its benefits over conventional stretching are unclear. A pilot randomized controlled trial (RCT) is warranted to assess the feasibility and acceptability of a definitive trial comparing FM with stretching. This study protocol describes a pilot randomized controlled feasibility trial comparing FM and stretching in children with CP to inform the design and conduct of a future definitive RCT.
Objective
The primary objective is to assess the feasibility and acceptability of the trial procedures and interventions. This includes evaluating recruitment and retention rates, intervention adherence, completion rates for outcome assessments, and the perceived impact of the interventions on children’s daily functioning and participation. The secondary objective is to explore the preliminary acute and longitudinal effects of FM, compared with traditional stretching, on walking performance, gait biomechanics, joint mobility, and the variability in these outcome measures.
Methods
This pilot RCT will include 20 children aged 7 to 14 years with spastic CP, randomized to an FM intervention group (n=10) and a stretching group (n=10). Both groups will receive 1 treatment session per week for 8 weeks. Feasibility and acceptability will be assessed using quantitative measures of recruitment and retention, intervention adherence, and completion of outcome assessments, complemented by semistructured interviews with caregivers and the children’s regular physiotherapists to explore perceived changes in the children’s daily functioning and participation, and their experiences of the interventions. Secondary outcomes include the 6-minute walk test (6MWT), walking metabolic cost, gait biomechanics, ankle spasticity, muscle activity, joint stiffness, and functional mobility in daily life. Acute outcomes will be assessed before and after the first intervention session, while longitudinal outcomes will be assessed at baseline and following the 8-week intervention period.
Results
Recruitment of participants began in October 2024, with 3 additional participants required to reach the target sample size. Results are expected to be published in 2027.
Conclusions
This pilot RCT will provide essential feasibility data and preliminary estimates of potential treatment effects to inform the design of a future adequately powered RCT. To our knowledge, evidence regarding the effects of FM on gait, mobility, and function in children with CP remains limited. This study aims to contribute to the development of evidence-based rehabilitation strategies for children with CP.