The Engineer-built System, Video-game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- range of motion
研究概览
简要总结
There are 3 phase of the study. This registration is phase 2.2. This registration will conduct a randomized controlled trial study in the cerebral palsy children. Due to the limitation of period of time of grant, we changed the study type into pilot-randomization. Our new method of study will collect all of our study which previously separated into pilot and randomized controlled trial in just only one study "pilot-randomization".
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 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spastic cerebral palsy aged 10-15 years
- •Sufficient cognitive/attention capacity to understand basic instructions
- •Can cooperate with the therapist for short period of time during training
- •Manual Ability Classification System (MACS) 2-3
- •Zancolli classification of the affected upper extremity was grade I-II.
- •Give the informed consent
排除标准
- •Inability to understand the instruction and follow the task
- •Severe comorbidities, visual or auditory impairment
- •Had history of Botulinum toxin injection on the affected upper extremity for last 6 months or receive the injection during the study time
- •Other treatment options planned on the affected upper extremity during the study time
- •Wear daytime orthosis on the affected limb
- •Zancolli classification of the affected hand was grade III.
- •Got an epilepsy or convulsive condition
- •Denied to give the informed consent or continue the study
结局指标
主要结局
range of motion
时间窗: before starting the intervention and after finishing the intervention within 1 week
The range or motion of shoulder, elbow and wrist will be assessed by goniometer. The assessment will be done before starting the intervention as the baseline and then after finishing the intervention to detect change of range of motion from the the baseline. The range of motion will be reported in degrees.
次要结局
- ABILHANDS-Kids(before starting the intervention and after finishing the intervention within 1 week)
- EQ-5D-Y(before starting the intervention and after finishing the intervention within 1 week)
- Box and block test(before starting the intervention and after finishing the intervention within 1 week)
研究者
Sivaporn Vongpipatana
Assistant Professor
Mahidol University