Functional Electrical Stimulation Assisted Cycling to Improve Fitness and Strength in 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
- 39
- 试验地点
- 2
- 主要终点
- Change in cycling Ability
研究概览
简要总结
This project proposes to assess if Functional Electrical Stimulation (FES) assisted cycling can improve the cycling ability, muscle strength, cardiovascular health, quality of life, self perception and functional mobility of adolescents with CP better than a volitional cycling program or a non-intervention control group.
详细描述
Aim 1: To compare the effects of 8-weeks of FES-assisted cycling training on improving cardiorespiratory fitness, walking function, self-motivated exercise/recreation, self-perception and functional mobility and quality of life of adolescents with spastic CP with marginal walking ability (Gross Motor Function Classification System Levels II - IV) vs. 8-weeks of volitional cycling training and a non-intervention control group.
Aim 2: To compare the effects of 8-weeks FES-assisted cycling training on changes in cycling ability of adolescents with spastic CP with marginal walking ability vs. 8-weeks of volitional cycling training and a nonintervention control group.
Aim 3: To elucidate the mechanisms for potential improvements in cycling ability after 8-weeks of FES-assisted or volitional cycling training of adolescents with spastic CP and marginal walking ability.
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
- None
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
- •Spastic CP (di-, tetra-, or triplegic)
- •Level II, III or IV GMFCS classification
- •Sufficient covering of the femoral head in the acetabulum (migration % < 40)
- •Adequate range of motion of the hips, knees and ankles to allow pedaling
- •Visual, perceptual, cognitive, and communication skills to follow multiple step commands for attending to exercise and data collection
- •Seizure-free or well controlled seizures
排除标准
- •Athetoid, ataxic, or hemiplegic CP
- •Significant scoliosis (primary curve > 40°)
- •Spinal fusions extending into the pelvis
- •Severe tactile hypersensitivity
- •Joint instability or dislocation in LE
- •LE surgery or fractures in the past year
- •Botox injections to LE in the past 6 months
- •Severe spasticity in LE (Mod Ashworth 4)
- •LE joint pain during cycling
- •Hx of pulmonary disease limiting exercise tolerance or Hx of cardiac disease
- •Severely limited ROM / contractures that prevent the subject from being able to be safely positioned on the cycle
- •Pregnancy
结局指标
主要结局
Change in cycling Ability
时间窗: Outcome assessed: Pre Training (week 0), Mid Training (week 4), Post Training (week 8), Follow-Up (week 16)
Change in cycling cadence from pre-training to post-training and at follow-up will be assessed.
Change in Energy Expenditure
时间窗: Outcome assessed: Pre Training (week 0), Mid Training (week 4), Post Training (week 8), Follow-Up (week 16)
Energy expenditure is a measure of cardiovascular fitness. Change in energy expenditure from pre-training to post-training and at follow-up will be assessed.
Change in Gait speed
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Gait speed will be measured using a GAITRite Portable Walkway System (CIR Systems Inc; Havertown, PA). We will measure the change in gait speed from pre-training to post-training and at follow-up.
Change in Spatiotemporal gait parameter
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Step length will be measured using a GAITRite Portable Walkway System (CIR Systems Inc; Havertown, PA). We will measure the change in step length from pre-training to post-training and at follow-up.
Change in Muscle Strength
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Isometric maximum voluntary exertion testing of hip extensors \& flexors, knee extensors \& flexors, and ankle plantarflexors. We will measure the change in isometric maximum voluntary exertion from pre-training to post-training and at follow-up.
Change in Walking Distance
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
6 minute walk test (6MWT) measures walking distance. Walking distance (in a fixed period of time) is an indicator of endurance. We will measure the change in walking distance from pre-training to post-training and at follow-up.
Change in Timed Up-And-Go
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Timed Up-And-Go (TUG) is a measure of functional mobility and will allow for assessing the impact of anticipated improvements in motor control and gait biomechanics. We will measure the change in TUG test from pre-training to post-training and at follow-up.
Change in Pedometer measurement
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Pedometer measurements to allow an unbiased report of the subject's activity level at home and in the community. We will measure the change in pedometer measurements from pre-training to post-training and at follow-up.
Change in Electromyography
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Muscle activation timing measured with electromyography (EMG) during analysis allows for mechanistic study of anticipated improvements in motor control as well as comparison to typical norms. We will measure the change in EMG from pre-training to post-training and at follow-up.
Change in Self-Assessment
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Canadian Occupational Performance Measure (COPM) is a 10 point scale to rate one's own level of performance and satisfaction with performance. 1 mean poor performance low satisfaction and 10 means very good performance high satisfaction. We will measure the change in COPM scores from pre-training to post-training and at follow-up.
Change in Health related Quality of Life
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
The KINDL questionnaire is administered to measure changes in health-related quality of life. The questionnaire is completed by the adolescent and a caregiver. The KINDL standard scale and "Disease Module" is administered. The standard scale contains 24 items comprised of Physical, Emotional, Self-Esteem, Family, Friends and School sub-scales. The 6-item "Disease Module" that measures the child's and caregiver's perceptions about CP. Scores for each item ranges from 1-5. The total score is the sum of all item scores, transformed to a 0-100 scale. Higher scores indicate better quality of life. We will measure the change in KINDL scores from pre-training to post-training and at follow-up.
Change in Self-Perception
时间窗: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Self-Perception (Piers-Harris-2) survey measures physical and emotional well-being and self-esteem and will allow assessment of the impact of anticipated improvements in motor control and gait biomechanics from training. We will measure the change in Piers-Harris scores from pre-training to post-training and at follow-up.
次要结局
未报告次要终点
研究者
Samuel C.K. Lee, PhD, PT
Principal Investigator, Associate Professor, Dept of Physical Therapy
University of Delaware