The Feasibility and Trend of Functional Changes by Using Home-based Exercise Program Delivered Through Telehealth With Coaching for Adolescents With Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
This study will provide exercise videos and live consultation sessions for adolescents with spastic cerebral palsy. We will recruit 20 participants with 10-18 years old and will be randomized into an experimental or control group. The experimental group will receive exercises videos 2 times a week and one time live consultation session for 8 weeks.
The Control group will receive exercise videos 3 times a week for 8 weeks. Both groups will use HIPAA compliant telehealth provider (Physitrack website/ app).
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 (Participant)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be diagnosed with spastic CP diagnosis, Gross Motor Functional Classification System (GMFCS) levels I-III) which will be confirmed by GMFCS-Extended Revised.
- •Between the ages of 11 and 18 years old.
- •Having a stable health status for 6 weeks prior to screening.
- •Having the cognitive ability to follow an exercise instruction in either written or electronic format, with or without support from their parents.
- •With an approval from parents/guardians for participating in this study.
- •Having access to the internet at home and access to the exercise's website/app via Personal computer (PC), laptop, or mobile app.
- •Being able to understand and follow verbal commands in English. The intervention and the questionnaires are available in English only.
排除标准
- •Subjects will be excluded if they have:
- •unstable medical condition during past 6 weeks,
- •had other neurological disorders that may cause further decline in balance and walking abilities (head injury, vestibular dysfunction, or Spinal cord injury),
- •or any musculoskeletal condition that would interfere with the safe performance of the exercise intervention or testing protocol,
- •scheduled surgical operations or castings during study period,
- •scheduled for intensive rehabilitation during 8 weeks of intervention.
结局指标
主要结局
Recruitment Rate
时间窗: post-intervention (after end of 8-weeks)
Recruitment rate will be calculated as the total number of patients recruited, divided by the maximum number of sites and then divided by the average number of months recruiting
Compliance Rate
时间窗: post-intervention (after end of 8-weeks)
Compliance rate will be calculated by number of participants who will complete the whole intervention duration and be examined post-intervention.
Canadian occupational performance measure score change
时间窗: Baseline, Post-intervention (after end of 8-weeks)
Achievements of individualized goals will be measured using the adapted version of COPM. For our study, 1-3 individualized goals are determined together by the parents/guardians, physical therapist, and investigators during the 2nd baseline visit. Children/parents will rate the current level of performance of each goal on scale 1-10 and satisfaction level of performance on scale 1-10, during the videoconferencing session along with physical therapist and investigators. The change in scores will be calculated (post-intervention score - Baseline score)
Adherence Rate
时间窗: post-intervention (after end of 8-weeks)
Adherence will be calculated as numbers: practice days, sessions, exercises, and repetitions.
次要结局
- Telehealth Usability Questionnaire (TUQ)(Post-intervention (after end of 8-weeks))
- The physical activity questionnaire for children (PAQ-C) and for Adolescents (PAQ-A)(Baseline, Post-intervention (after end of 8-weeks))
- The Physical Activity and Enjoyment Scale (PACES)(Baseline, Post-intervention (after end of 8-weeks))
- pediatric pain questionnaire (PPQ)(Baseline, Post-intervention (after end of 8-weeks))
- The Correctness of Exercise Performance (COEP)(Baseline, halfway of intervention (after end of 4-weeks), Post-intervention (after end of 8-weeks))
- Children Sleep Habits Questionnaire(CSHQ)(Baseline, Post-intervention (after end of 8-weeks))
- The Cerebral Palsy Quality of Life Questionnaire (CP-QOL)(Baseline, Post-intervention (after end of 8-weeks))