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

NCT06820398 | Recruiting

• 1 other identifier: 3498583
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

Functional Exercise; Strength; Resistance; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• Functional Percentile Based on Gross Motor Function Classification System (GMFCS)

  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 Outcomes (3)

• Quality of Life Assessed with CP-QOL Questionnaire

  Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).

• Participation in Daily Environments Assessed with PEM-CY

  Baseline(pre-intervention) and immediately post-intervention (at 18 weeks).

• Baseline Heart Rate

  Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).

Study Arms (2)

Functional exercise with progressive strength and resistance load

EXPERIMENTAL

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

Other: Functional exercise with progressive strength and resistance load

Functional exercises without any load

ACTIVE COMPARATOR

This group will perform functionalexercises without strength orresistance load.

Other: Functional exercises without any load

Interventions

Functional exercise with progressive strength and resistance load OTHER

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

Functional exercise with progressive strength and resistance load

Functional exercises without any load OTHER

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

Functional exercises without any load

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy. University of Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• 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 DIRECTOR

Central Study Contacts

M.Luz Sánchez-Sánchez, PhD

CONTACT

963983853; m.luz.sanchez@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physiotherapy

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

ES (1)