Clinical trial NCT06820398: Effects of Functional Exercise Program With Strength Load and Resistance in Children and Adolescents With Cerebral Palsy
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Functional Exercise
Strength
Resistance
Children
Adolescents
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional Percentile Based on Gross Motor Function Classification System (GMFCS)
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
Secondary outcomes:
measure: Quality of Life Assessed with CP-QOL Questionnaire
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
measure: Participation in Daily Environments Assessed with PEM-CY
timeFrame: Baseline(pre-intervention) and immediately post-intervention (at 18 weeks).
measure: Baseline Heart Rate
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy. University of Valencia
Study officials:
affiliation: University of Valencia
name: M.Luz Sánchez-Sánchez, PhD
role: STUDY_DIRECTOR
affiliation: Cardenal Herrera University
name: Juan Francisco Lison Párraga, PhD
role: STUDY_DIRECTOR
affiliation: Cardenal Herrera University
name: María Dolores Arguisuelas Martínez, PhD
role: STUDY_DIRECTOR
References: