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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Functional Percentile Based on Gross Motor Function Classification System (GMFCS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 10 to 18 years.
- •Diagnosis of spastic cerebral palsy (CP).
- •Classification at levels III or IV of the GMFCS scale.
排除标准
- •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.
研究组 & 干预措施
Functional exercise with progressive strength and resistance load
This group will perform functionalexercises with progressive strengthand resistance load, adjusted basedon heart rate.
干预措施: Functional exercise with progressive strength and resistance load (Other)
Functional exercises without any load
This group will perform functionalexercises without strength orresistance load.
干预措施: Functional exercises without any load (Other)
结局指标
主要结局
Functional Percentile Based on Gross Motor Function Classification System (GMFCS)
时间窗: 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.
次要结局
- Quality of Life Assessed with CP-QOL Questionnaire(Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).)
- Participation in Daily Environments Assessed with PEM-CY(Baseline(pre-intervention) and immediately post-intervention (at 18 weeks).)
- Baseline Heart Rate(Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).)
研究者
M Luz Sanchez
Associate Professor of Physiotherapy
University of Valencia