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

University of Valencia

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Other: Functional exercises without any load; Other: Functional exercise with progressive strength and resistance load

Study type: Interventional

Funder types: Other

Identifiers

NCT06820398

3498583

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescents aged 10 to 18 years.
• Diagnosis of spastic cerebral palsy (CP).
• Classification at levels III or IV of the GMFCS scale.

Exclusion criteria

• Multilevel surgery with osteotomy within the last 12 months.
• Microtenotomies or percutaneous needle lengthening (APAI) within the last 9months.
• Botulinum toxin injections within the last 3 months.
• Participation in specific strength training protocols.
• Lack of cognitive ability to perform the intervention protocol activities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Functional exercise with progressive strength and resistance load

Experimental group

Description:

This group will perform functionalexercises with progressive strengthand resistance load, adjusted basedon heart rate.

Treatment:

Other: Functional exercise with progressive strength and resistance load

Functional exercises without any load

Active Comparator group

Description:

This group will perform functionalexercises without strength orresistance load.

Treatment:

Other: Functional exercises without any load