Promoting Active Healthy Lifestyle of Adolescents With Brain Damage Due to Traumatic Brain Injury and Cerebral Palsy
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- an ActivPAL3™ (PAL Technologies, Glasgow, UK) tri-axial accelerometer-based activity monitor.
研究概览
简要总结
Long hours of daily sitting and lack of Physical Activity (PA) are risk factors for morbidity and mortality.
People with movement disabilities, including adolescents with Cerebral Palsy (CP) tend to lead a sedentary life styl and have have poor physical fitness. Adolescents with CP where found to be inactive most of the day thus, they are in greater risk of disease than the general population. In addition, over the years, people with disabilities experience physical and functional deterioration. Reducing sedentary behavior and increasing daily activity can reduce health risk factors among the adolescents with CP, reduce secondary impairments and preserve function.
Interventions that included exercise alone has not resulted in physical activity and participating in a structured training did not continue after cessation intervention.
The objectives of this study are to establish effective programs aiming to promote an active life style among adolescents and young adults with CP and to evaluate there outcomes.
Specific objectives- Stage 1- Identifying barriers and facilitators for reducing sedentary behaviors and increasing physical activity among adolescents and young adults with CP. As well as, identifying mediators, needs and preferences for reducing sedentary behaviors and increasing physical activity among adolescents and young adults with CP.
Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and increasing physical activity among adolescents.
Stage 3- translating and developing questioners for the study.
- Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and validating the Hebrew translation.
- Developing a self-efficacy perception questioner for increasing physical activity and reducing and sedentary behavior.
- Translating to Hebrew, adjusting and validating an activity diary.
Stage 4- evaluating the effectiveness of the proposed intervention program on reducing sedentary behaviors and increasing physical activity among adolescents and young adults with CP.
详细描述
Stage 1 focus group- Identifying barriers and facilitators for reducing sedentary behaviors and increasing physical activity as well as, identifying mediators, needs and preferences for reducing sedentary behaviors and increasing physical activity.
Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and increasing physical activity among adolescents. The intervention group will receive behavior-modification in group. The control group will get physical exercises.Stage 3- translating and developing questioners for the study.
- Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and validating the Hebrew translation.
- Developing a self-efficacy perception questioner for increasing physical activity and reducing and sedentary behavior.
- Translating to Hebrew, adjusting and validating an activity diary.
Stage 4- evaluating the effectiveness of the proposed intervention program on reducing sedentary behaviors and increasing physical activity among adolescents and young adults with CP. The outcome measures will measure change from base line after intervention and 4-6 months after intervention finished.
All partners of this project will obtain approval for experiments on human subjects from their local committees. Each subject (or parents/guardians for the participation of minor subjects) will be able to sign an informed voluntary consent form, consistent with the Helsinki Declaration, after reading a detailed explanation and having an oral Q/A session with the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intervention group:
- •children, adolescents and young adults age 14-25 yrs
- •with bilateral spastic Cerebral Palsy
- •at GMFCS level I, II and III
- •can speak their native language fluently
- •able to follow verbal instructions
- •willing to train in a group.
- •For ASK: age 5-18yrs.
- •children, adolescents and young adults age 5-18yrs
- •with bilateral spastic Cerebral Palsy
- •at GMFCS level I, II and III
- •can speak their native language
- •able to follow verbal instructions
- •The exclusion criteria:
- •Individual who had orthopedic surgery or tone reduction interventions (e.g. botulinum toxin injections, or have a history of baclofen pump or selective dorsal rhizotomy within 6 months prior to this study
- •have exercise induced asthma or cardiac problems.
排除标准
- 未提供
结局指标
主要结局
an ActivPAL3™ (PAL Technologies, Glasgow, UK) tri-axial accelerometer-based activity monitor.
时间窗: Measuring changes: Base line: time 1 before intervention. time 2: changes immediately after finish intervention. time 3: changes 6 months after time 2.
tri-axial accelerometer-based activity monitor. ActivePal accelerometer, is currently considered a reference method for discriminating sitting, standing, and ambulation.
次要结局
- Self efficiency questionnaire(Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. 4 months after starting intervention.)
- 6minWT(Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.)
- 10MWT(Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.)
- TUG(Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.)
- FMS(Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.)
- ASK(Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.)
- PEDI-CAT(Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention, 4 months after starting intervention.)