跳至主要内容
临床试验/NCT02808195
NCT02808195已完成不适用

Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年8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
已完成
入组人数
60
试验地点
1
主要终点
Performance Change assessed by Kinematic analysis

研究概览

简要总结

The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.

详细描述

The specific aims of this study project will be:

To compare the effectiveness of intervention groups using Kinect-based ULMTS with constraint-induced therapy on motor improvement in children with hemiplegic CP. The investigators hypothesize that motor improvement in using Kinect-based ULMTS will be comparable to constraint-induced therapy.

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
3 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •3-16 years old
  • •diagnosed with congenital hemiplegic or CP with one more affected side
  • •considerable nonuse of the affected upper limb.

排除标准

  • •no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon & Smith, 1987)
  • •no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
  • •no injections of botulinum toxin type A or operations on the upper limb within 6 months.

研究组 & 干预措施

constraint-induced therapy

Experimental

training of the more affected arm and restraint the less affected arm

干预措施: Constraint-induced therapy (Other)

kinect-based constraint-induced therapy

Experimental

training of the more affected arm and restraint the less affected arm by kinect-game

干预措施: kinect-based constraint-induced therapy (Other)

结局指标

主要结局

Performance Change assessed by Kinematic analysis

时间窗: baseline, 2 months and 6 months

Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.

次要结局

  • score change of Melbourne Assessment 2 (MA2)(baseline, 1 months, 2 months and 6 months)
  • score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL)(baseline, 1 months, 2 months and 6 months)
  • score change of Test of Playfulness (TOP)(baseline, 1 months, 2 months and 6 months)
  • score change of Engagement Questionnaire (EQ)(baseline, 1 months, 2 months and 6 months)
  • score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)(baseline, 1 months, 2 months and 6 months)
  • score change of Pediatric Motor Activity Log-Revised (PMAL-R)(baseline, 1 months, 2 months and 6 months)
  • score change of ABILHAND-kids(baseline, 1 months, 2 months and 6 months)
  • score change of Test of Visual Perceptual Skills-3rd (TVPS-3)(baseline, 1 months, 2 months and 6 months)
  • score change of Functional Independence Measures for children (WeeFIM)(baseline, 1 months, 2 months and 6 months)
  • score change of Parenting Stress Index-Short Form (PSI-SF)(baseline, 1 months, 2 months and 6 months)
  • score change of Pediatric evaluation of disability inventory (PEDI)(baseline, 1 months, 2 months and 6 months)
  • score change of Clint Satisfaction Questionnaire (CSQ)(baseline, 1 months, 2 months and 6 months)
  • score change of Building Tower Test(baseline, 1 months, 2 months and 6 months)
  • score change of Test of String Beads(baseline, 1 months, 2 months and 6 months)
  • score change of Box and Block Test(baseline, 1 months, 2 months and 6 months)
  • Muscle strength(baseline, 2 months and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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