Cerebral Palsy
Conditions
Keywords
Functional Exercise, Strength, Resistance, Children, Adolescents
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.
Interventions
OTHERFunctional exercise with progressive strength and resistance load
This group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate.
OTHERFunctional exercises without any load
This group will perform functional exercises, without strength or resistance load
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Percentile Based on Gross Motor Function Classification System (GMFCS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessed with CP-QOL Questionnaire | 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). |
| Participation in Daily Environments Assessed with PEM-CY | 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. |
| Baseline Heart Rate | 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. |
Countries
Spain
Contacts
Primary ContactM.Luz Sánchez-Sánchez, PhD
Outcome results
None listed