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

NCT ID: NCT06820398

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Functional exercise with progressive strength and resistance load

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

Group Type EXPERIMENTAL

Functional exercise with progressive strength and resistance load

Intervention Type OTHER

This group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate.

Functional exercises without any load

This group will perform functionalexercises without strength orresistance load.

Group Type ACTIVE_COMPARATOR

Functional exercises without any load

Intervention Type OTHER

This group will perform functional exercises, without strength or resistance load

Interventions

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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.

Intervention Type OTHER

Functional exercises without any load

This group will perform functional exercises, without strength or resistance load

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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M Luz Sanchez

Associate Professor of Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M.Luz Sánchez-Sánchez, PhD

Role: STUDY_DIRECTOR

University of Valencia

Juan Francisco Lison Párraga, PhD

Role: STUDY_DIRECTOR

Cardenal Herrera University

María Dolores Arguisuelas Martínez, PhD

Role: STUDY_DIRECTOR

Cardenal Herrera University

Locations

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Faculty of Physiotherapy. University of Valencia

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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M.Luz Sánchez-Sánchez, PhD

Role: CONTACT

963983853

Facility Contacts

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M.Luz Sánchez-Sánchez, PhD

Role: primary

963983853

Other Identifiers

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3498583

Identifier Type: -

Identifier Source: org_study_id

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