A Prospective Study of Two Home Based Muscle Strengthening Programs for Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in time for 6 minute Walk Test
研究概览
简要总结
The aim of this randomized, stratified, single-blinded study is to compare two home based strength-training protocols (High Intensity Interval Training and Progressive Resistance Training) and their effects on muscle strength, gait and aerobic and anaerobic capacity in children with cerebral palsy.
详细描述
Cerebral palsy is a common neuro-developmental disorder. Among other signs of upper motor neuron syndrome, walking pathologies and muscle weakness are leading signs of disability in children with cerebral palsy. Moreover, the gradual decline in muscle strength is part of the aging process and can be particularly devastating for people with motor disabilities. Therefore muscle-strengthening programs are indicated for children with cerebral palsy. There is evidence that lower extremity muscle strength can be increased by Progressive Resistance Training (PRT) in children with cerebral palsy. However, PRT is time consuming and therefore not always feasible for children with neurologic disorders. Moreover, it does not influence the anaerobic capacity needed for everyday activities in children. High Intensity Interval Training (HIIT) is a time efficient method, which increases both aerobic and anaerobic capacities. The aim of this randomized, stratified, single-blinded study is to compare two home based strength-training protocols (HIIT and PRT) and their effects on muscle strength, gait and aerobic and anaerobic capacity in children with cerebral palsy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory children with unilateral or bilateral spastic cerebral palsy
- •Age between 8-16 years
- •Ability to accept and follow verbal instruction
- •Gross Motor Function Classification System (GMFCS) at level I-II
- •Willingness to participate
排除标准
- •Other than spastic form of cerebral palsy (ataxia, athetoid or dystonic)
- •Quadriplegia
- •History of orthopaedic surgery in the last 12 months
- •History of Botulinum Toxin A application in the last 6 months
- •Severe mental retardation
研究组 & 干预措施
Progressive Resistance Training
The key for the PRT is the timely progression of load, based on the child's individual level of strength, which ensures progressive overload.
Every training session will consist of a warm up, progressive resistance exercises and a cool down period. During warm up and cool down periods.These exercises will be the same for both training groups.
The strength training exercises have been chosen to strengthen the main lower extremity muscle groups which are important for the gait: sit-to-stand, lateral step-ups, the half knee rise, heel-rises and bridging.
All these exercises are performed loaded according to the individual level. Three sets of 8 to 10 repetitions of each exercise will be practiced on 3 non-consecutive days with moderate velocity.
干预措施: Progressive Resistance Training (Other)
High Intensity Interval Training
The High Intensity Circuit Training is a sub form of High Intensity Interval Training. The key feature is the very little rest between the exercises which causes a consistent elevation of the participant's heart rate and a short duration of the whole exercise session. Every training session consists of a warm-up, a circuit of 5 exercises (the same as these in the PRT group) and a cool-down period. The children will be asked to train 3 times a week on non-consecutive days and to perform 3 sets. Exercise workload is controlled by determination of time intervals (30 seconds). The children will be instructed to perform as many repetitions as possible during the exercise interval and to keep the rest between the exercises short (it must not exceed 30 seconds).
干预措施: High Intensity Interval Training (Other)
结局指标
主要结局
Change in time for 6 minute Walk Test
时间窗: between baseline and 2 months later (end of intervention)
The 6 minute walk test is a self-paced, submaximal test that assesses functional capacity for walking a prolonged distance. The distance reached within 6 minutes of walking is evaluated.
次要结局
- Change of 3D Gait Analysis data(between baseline and 2 months later (end of intervention))
- Change in Spasticity measurements (Modified Ashworth Scale)(between baseline and 2 months later (end of intervention))
- Change in metabolomics data(between baseline and 2 months later (end of intervention))
- Change in time for Muscle Power Sprint Test(between baseline and 2 months later (end of intervention))
- Change in time for Timed Stair Test(between baseline and 2 months later (end of intervention))
- Change in hand held dynamometer muscle strength measurements(between baseline and 2 months later (end of intervention))
- Change in Range of Motion measurements (Goniometer)(between baseline and 2 months later (end of intervention))
- Change in Energy Expenditure Index(between baseline and 2 months later (end of intervention))
- Change in Results of Dynamometry, Ultrasound imaging, Electromyography - Analysis of the muscle-tendon unit morphology and physiology measurements of the calf muscles(between baseline and 2 months later (end of intervention))
- Change in results of Pediatric Outcome Data Collection Instrument (PODCI) and Activity Scale for kids performance version (ASKp) questionnaires(between baseline and 2 months later (end of intervention))
- Change in time for Timed Up and Go Test(between baseline and 2 months later (end of intervention))
研究者
Svehlik Martin, MD PhD
Senior surgeon
Medical University of Graz