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

February 5, 2025 updated by: M Luz Sanchez, University of Valencia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Recruiting
        • Faculty of Physiotherapy. University of Valencia
        • Contact:
        • Principal Investigator:
          • Sergio Muñoz-Beato, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional exercise with progressive strength and resistance load
This group will perform functionalexercises with progressive strengthand resistance load, adjusted basedon heart rate.
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.
Active Comparator: Functional exercises without any load
This group will perform functionalexercises without strength orresistance load.
Other: Functional exercises without any load
This group will perform functional exercises, without strength or resistance load

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Percentile Based on Gross Motor Function Classification System (GMFCS)
Time Frame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
This variable represents the functional percentile calculated using the Gross Motor Function Classification System (GMFCS) and related measures. It incorporates: 1)GMFCS: A five-level system classifying gross motor movement capacity; 2) GrossMotor Function Measure (GMFM-66 and GMFM-88): Tools for evaluating grossmotor function across multiple dimensions; and 3) GMAE-2 Software: Generatesfunctional percentiles based on GMFM data. Values range from 0 to 100, where 0 represents the lowest functional percentile and 100 the highest.
Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Assessed with CP-QOL Questionnaire
Time Frame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
This variable evaluates the quality of life of caregivers and adolescents using theCerebral Palsy Quality of Life Questionnaire (CP-QOL). The questionnaireassesses multiple domains of well-being and quality of life related to cerebral palsy.Values depend on the raw or normalized scores, which may vary depending on thescoring method. If normalized, scores range from 0 (lowest quality of life) to 100(highest quality of life).
Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
Participation in Daily Environments Assessed with PEM-CY
Time Frame: Baseline(pre-intervention) and immediately post-intervention (at 18 weeks).
This variable measures the participation of children and adolescents aged 5-18years in daily environments using the Participation and Environment Measure forChildren and Youth (PEM-CY). The PEM-CY evaluates both the frequency ofparticipation in various activities and the impact of environmental factors. Valuesare reported on scales specific to PEM-CY domains, where higher scores indicategreater participation and/or better environmental support.
Baseline(pre-intervention) and immediately post-intervention (at 18 weeks).
Baseline Heart Rate
Time Frame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
This variable represents the baseline heart rate, measured in beats per minute(bpm). It is recorded under resting conditions prior to any intervention or physicalactivity. Values range from 40 to 120 bpm, where lower values are associated withgreater tolerance to exercise.
Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Study Director: M.Luz Sánchez-Sánchez, PhD, University of Valencia
  • Study Director: Juan Francisco Lison Párraga, PhD, Cardenal Herrera University
  • Study Director: María Dolores Arguisuelas Martínez, PhD, Cardenal Herrera University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3498583

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on Functional exercise with progressive strength and resistance load

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe