跳至主要内容
临床试验/NCT01267929
NCT01267929已完成不适用

Effects of Mirror Neurons Stimulation on Motor Skill Rehabilitation in Children With Cerebral Palsy

Thammasat University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年9月最近更新:
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
30
试验地点
2
主要终点
The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month.

研究概览

简要总结

This study aimed to develop Video Compact Disc (VCD) program that applying the concept of imitative learning with mirror neurons stimulation on standard rehabilitation technique in children with cerebral palsy. The author will also examine effectiveness of the program by compare the motor function measured by the gross motor function measure (GMFM-66) between conventional physical therapy and the mirror neurons stimulation based VCD program for six months.

详细描述

A randomized controlled trial was performed with thirty children with cerebral palsy recruited from Thammasat University Hospital and Rajanukul institute. Informed consent was obtained from the participants' parents before participation in this study. The participants were randomly assigned according to the randomization list to receive either the mirror neurons stimulation based VCD program and practice at home or conventional physical therapy for six months. The participants in the experiment group received the mirror neurons stimulation based VCD program and practice at home three times a day for six months. Concerning the control group, the participants received conventional physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. Both experimental and control groups were measured their motor functions with gross motor function measure (GMFM-66).

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
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with cerebral palsy aged between 2-10 years old
  • GMFCS level of one to three
  • Able to verbal instruction
  • Sitting are performed without assistance
  • Standing and walking are performed with adult assistance
  • No severe limitation of joint movement

排除标准

  • The children were received orthopedic intervention or botulinum toxin injection within 6 months
  • Other conditions that prevent children from participate in research project
  • Severe visual and hearing deficits

研究组 & 干预措施

The mirror neurons stimulation based VCD program

Experimental

The children receive the mirror neurons stimulation based VCD program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.

干预措施: The mirror neurons stimulation based VCD program (Procedure)

The conventional physical therapy

Active Comparator

The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.

干预措施: The conventional physical therapy (Procedure)

结局指标

主要结局

The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month.

时间窗: Base line, two months and six months

The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates \< 10% of activity,2=partially completes 10% to \< 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills.

次要结局

未报告次要终点

研究者

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

Namfon Mahasup

Ph.D.candidate, Postgraduate Studied Program, faculty of Medicine, Thammasat University

Thammasat University

研究点 (2)

Loading locations...

相似试验