Does Participating in a Supervised Fitness Program Extend the Benefits of Episodic Physical Therapy More Than a Home Exercise Program for Adults With Cerebral Palsy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Testing Version (PEDICAT) score
研究概览
简要总结
The purpose of this study is to compare the effectiveness of 2 community intervention approaches to maintain community mobility and walking speed in adults with cerebral palsy who have previously completed an 8 week course of physical therapy.
详细描述
The proposed study will address the lifelong need for fitness in adults with cerebral palsy compared to individuals provided with a home exercise program at the end of their individualized physical therapy, individuals in the fitness group will...
Primary Hypothesis:
- Have higher Pediatric Evaluation of Disability Inventory Computer Adapted Test (PEDICAT) scores at the +12 weeks post intervention visit
- Increase their PEDICAT scores across the study period, while the home fitness group will decrease performance on the PEDICAT.
- Complete the Timed Up and Go (TUG) more quickly at +12 weeks post intervention
Secondary Hypothesis (study not powered for these variables): 4. Walk further on the Six Minute Walk Test (6MWT) at the +12 weeks post intervention visit
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)
盲法说明
Outcome assessors will be blinded to group assignment. It is not possible to blind the participants or the care providers.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with cerebral palsy Gross Motor Function Classification System (GMFCS) level I, II, or III
- •Completion of episode of physical therapy provided by the Developmental Disabilities program at Sheltering Arms within the one month prior to the baseline assessment
- •Lives within the community in their own home or group housing
排除标准
- •GMFCS level IV or V
- •Unable to follow two-step directions
- •Adults who have a medical or legal power of attorney who sign their health authorization
研究组 & 干预措施
Home Group
干预措施: Home Exercise Group (Behavioral)
Center Group
干预措施: Fitness Center Group (Behavioral)
结局指标
主要结局
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Testing Version (PEDICAT) score
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
The PEDI-CAT assesses function in 4 domains: Daily Activity, Mobility, Social/Cognitive, Responsibility
Change in Timed Up and Go (TUG) score
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
Mobility assessment measuring amount of time it takes for participant to get up from chair, walk to a line on the floor at a normal pace, and return to a seated position
次要结局
- Change in six-minute walk test (6MWT)(Baseline, 4 weeks, 8 weeks, 12 weeks)