跳至主要内容
临床试验/NCT05338229
NCT05338229撤回不适用

The Engineer-built System, Video-game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children: Phase 2.1

Mahidol University0 个研究点开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Range of Motion

研究概览

简要总结

There are 3 phases of the study. This registration is phase 2.1.This registration will conduct a pilot study in the cerebral palsy children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

研究组 & 干预措施

video game in CP children (pilot study)

Experimental

The cerebral palsy children will play the engineer-built system, video-game based Kinect sensor 3 times/week for 5 weeks. Each session will last for 40 minutes. The video-game Kinect sensor was developed by the researcher team.

干预措施: the engineer-built system, video-game based Kinect sensor (Device)

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

  • 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)
  • ABILHANDS-Kids(before starting the intervention and after finishing the intervention within 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sivaporn Vongpipatana

Assistant Professor

Mahidol University

相似试验