Actively Recruiting
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
Led by University of Valencia · Updated on 2025-02-11
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a functional exercise program that includes strength and resistance load in adolescents aged 10 to 18 years with spastic cerebral palsy classified at levels III and IV of the Gross Motor Function Classification System (GMFCS). This randomized controlled trial aims to analyze changes in motor function, quality of life, and participation in daily environments using validated assessment scales. The study is conducted by the University of Valencia and follows ethical guidelines including CONSORT and the Declaration of Helsinki. Participants are randomly assigned to one of two groups: an intervention group performing functional exercises with progressive strength and resistance load adjusted by heart rate, and a control group performing the same exercises without any load. The program consists of 36 sessions over 18 weeks. Evaluations are done at baseline, immediately after the intervention, and six months post-intervention to assess the outcomes. During the study, participants will undergo assessments of their functional motor abilities using the GMFCS percentile, quality of life through the CP-QOL questionnaire, and participation in daily settings with the PEM-CY measure. Heart rate is monitored to adjust exercise load for the intervention group. The total participation includes the 18-week exercise program plus a 6-month follow-up period to observe lasting effects and safety.
CONDITIONS
Brief Title
Effects of Functional Exercise Program With Strength Load and Resistance in Children and Adolescents With Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents aged 10 to 18 years
- Diagnosis of spastic cerebral palsy
- Classified at levels III or IV of the Gross Motor Function Classification System (GMFCS)
You will not qualify if you...
- Multilevel surgery with osteotomy within the last 12 months
- Microtenotomies or percutaneous needle lengthening within the last 9 months
- Botulinum toxin injections within the last 3 months
- Participation in specific strength training programs
- Lack of cognitive ability to perform the intervention activities safely and effectively
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 weeks
Participants perform a functional exercise program with or without progressive strength and resistance load over 18 weeks.
36 exercise sessions over 18 weeks
Duration - 6 months
Participants are evaluated six months after completing the exercise program to assess long-term effects.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Faculty of Physiotherapy. University of Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
M
M.Luz Sánchez-Sánchez, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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