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临床试验/NCT05995197
NCT05995197尚未招募不适用

The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy

Medipol University0 个研究点目标入组 24 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
主要终点
Pediatric balance scale

研究概览

简要总结

type of study: clinical trial the goal of this study is to learn about action observation therapy for cerebral palsy population.

The main question it aim to answer is:

Is action observation therapy effective on balance in children with cerebral palsy? Twenty-four children who met the inclusion criteria in the study will be randomly divided into two groups as the training group(action observation group) and the control group.

详细描述

The history and demographic information of all cases will be obtained.Action observation therapy will be applied to improve balance. The therapist will verbally explain the program to be applied to both groups. Children with CP will watch the video on the computer screen placed 1 m in front of a chair in which they can sit comfortably, but they will not be allowed to move while watching the video. Children with CP will watch the video of the exercise offered by the therapist and then practice the exercise. The watching time for each exercise is 3 minutes, and after watching 3 minutes, they will do the exercise in the video for 3 minutes. The control group will be shown cartoons. After 3 minutes of monitoring, each exercise will be studied for 3 minutes. In order to increase the effectiveness of the action observation training, the participants will watch the video at the designated time in a quiet and noiseless place. Children will be instructed to concentrate on the video at 1-minute intervals to allow children's attention span. The treatment program will be applied for 30 minutes, 5 days a week for 3 weeks. The first session of the exercise program will be held face-to-face and the other sessions will be followed online. Treatment will be started within the first 48 hours after the evaluation. After the applications, the evaluations at the beginning of the session will be repeated.

Physiotherapy program to be applied:

First week:

  • Double-leg balancing on soft ground with eyes open, hands free
  • Balance on both feet on soft ground with eyes closed, hands free
  • Stand on one leg with eyes open on hard ground
  • Stand on one leg on hard ground with eyes closed

Second week:

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 (Participant)

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with CP
  • To be at I and II levels according to the Gross Motor Function Classification System
  • Having bilateral and unilaterally affected spastic type CP
  • Cooperating with assessments
  • Absence of vision and hearing loss
  • According to the health board report, only motor skills are affected

排除标准

  • Botulinum toxin application in the last 6 months Having had any surgical operation in the last 6 months
  • Having dyskinetic, ataxic and hypotonic type CP
  • Not attending treatment sessions regularly for 2 weeks
  • Not participating in the pre- and post-treatment evaluation

结局指标

主要结局

Pediatric balance scale

时间窗: 2 days before treatment and after 3 weeks

The pediatric balance scale is a modified version of the Berg balance scale and is used to evaluate the functional balance ability of school-age children. The scale consists of 14 items, scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56.

次要结局

  • Nintendo Wii-Fit Balance Score(2 days before treatment and after 3 weeks)
  • Lower Extremity Selective Control Evaluation Scale (SCALE)(2 days before treatment and after 3 weeks)
  • Pediatric Outcome Data Collection Instrument (PODCI)(2 days before treatment and after 3 weeks)
  • Gross motor function classification system(2 days before treatment)
  • Gross motor function measurement-88(2 days before treatment and after 3 weeks)
  • Trunk Impairment Scale(2 days before treatment and after 3 weeks)
  • Functional Near Infrared Spectroscopy (fNIRS) Application(2 days before treatment and after 3 weeks)
  • Timed Get Up and Go Test (TUG)(2 days before treatment and after 3 weeks)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

melike özipek

physiotherapist

Medipol University

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