NCT06820398

Effects of Functional Exercise Program With Strength Load and Resistance in Children and Adolescents With Cerebral Palsy

Effects of Functional Exercise Program With Strength Load and Resistance in Gross Motor Function, Quality of Life and Participation in Children and Adolescents With Cerebral Palsy Levels III-IV GMFCS

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This research project aims to evaluate the benefits of a functional exercise program with strength and resistance load in adolescents with cerebral palsy (CP), specifically classifiedat levels III and IV of the Gross Motor Function Classification System (GMFCS) scale. Participants will be included into control or intervention group in this randomized controlled trial. Changes in functional percentile, quality of life, and participation in daily environments will be analyzed based on scores obtained with validated assesment scales. The study will be conducted at the Children's Neurorehabilitation Unit of Hospitalarias Foundation in Valencia, with an 18-week intervention plus a 6-month follow-up. This project seeks to provide evidence on rehabilitation strategies that promote autonomy and social inclusion for this population.

Detailed description

This research project is a randomized controlled trial designed to analyze the effects of a functional exercise program with strength and resistance load in adolescents with CP specifically classified at levels III and IV of the GMFCS scale. The study will include around 40 participants aged 10 to 18 years, randomly assigned to either an intervention group or a control group. The intervention group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate. The control group will perform the same functional exercises but without any load. The protocol includes 36 sessions over 18 weeks, with evaluations at three key time points: before the intervention, at the end of the protocol, and six months post-intervention. The primary outcomes include functional percentile within the GMFCS, quality of life asperceived by patients and caregivers, and participation in daily environments. The study will adhere to CONSORT guidelines and the Declaration of Helsinki and has been reviewed by an ethics committee.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
OTHER	Functional exercise with progressive strength and resistance load	This group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate.
OTHER	Functional exercises without any load	This group will perform functional exercises, without strength or resistance load

Timeline

• Start date: 2025-01-31
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-02-11
• Last updated: 2025-02-11

Locations

1 site across 1 country: Spain