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NCT Number: NCT06820398

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physiotherapy. University of Valencia

Valencia, 46010, Spain

Location status: Recruiting

Location contact

M.Luz Sánchez-Sánchez, PhD

CONTACT

[email protected]

963983853

Sergio Muñoz-Beato, MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 exercises without any load

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

M.Luz Sánchez-Sánchez, PhD

CONTACT

[email protected]

963983853

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Acronym: FESCA_CP

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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