Effects of Functional Exercise Program With Strength Load and Resistance in Children and Adolescents With Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional exercise with progressive strength and resistance load, Functional exercises without any load.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy. Basic parameters: 10 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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. - Other Functional exercises without any load
This group will perform functional exercises, without strength or resistance load
Primary outcome measures
- Functional Percentile Based on Gross Motor Function Classification System (GMFCS) [Time frame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).]
Secondary outcome measures (3)
- Quality of Life Assessed with CP-QOL Questionnaire [Time frame: 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).]
- Baseline Heart Rate [Time frame: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Faculty of Physiotherapy. University of Valencia — Valencia
Identifiers
NCT: NCT06820398 · 3498583