Piloting a Novel Home-based Telehealth Movement-to-music Program (M2M) for Increasing Physical Activity Among Adolescents With Cerebral Palsy: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Changes in physical activity participation
研究概览
简要总结
This study pilots the efficacy of a home-based movement-to-music program for increasing physical activity participation among adolescents with cerebral palsy. Half of the participants will receive the movement-to-music program immediately, which will include 4 weeks of exercise videos and periodic behavioral coaching calls. The other half of participants will wait 4 weeks before receiving the M2M program.
详细描述
The movement-to-music program has been tested among adults with physical disabilities and is currently being used in ongoing scale-up clinical trials. Current evidence suggests that the program can increase aspects of physical function among adults. The present study aims to test whether the same program can be used among adolescents with cerebral palsy. Study findings will be used to examine whether the videos require modifications prior to being implemented in a future scale-up trial for adolescents people 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
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of cerebral palsy
- •Be able to exercise with arms or be assisted through the movements by a parent
- •Be between the ages of 10-19 years
- •Have access to a Wi-Fi Internet connection at your home
- •Have access to a device that Is capable of viewing videos from YouTube (a television, computer tablet, laptop, or desktop)
排除标准
- •Does more than 60 minutes of moderate-to-vigorous physical activity per day in a normal week
- •Has complete blindness or deafness
结局指标
主要结局
Changes in physical activity participation
时间窗: Baseline and Week 4
Participation in home, extracurricular, and community activities measured via the Children's Assessment of Participation and Enjoyment (CAPE). The CAPE is used to document changes in everyday activities outside of the school-setting. The CAPE provides 3 levels of scoring: 1) overall participation scores; 2) domain scores that reflect participation in formal and informal activities; and 3) scores that reflect participation in 5 types of activity (active, physical, recreation, social, skill-based, and self-improvement activities).
次要结局
- Changes in Self-efficacy(Baseline and Week 4)
- Changes in Goal-setting(Baseline and Week 4)
- Changes in Social support(Baseline and Week 4)
- Changes in Outcome expectations(Baseline and Week 4)
- Video Minutes Completed Throughout the Intervention (Adherence)(Week 1 through Week 4)
研究者
Byron Lai
Principle Investigator
University of Alabama at Birmingham