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临床试验/NCT03845855
NCT03845855已完成不适用

The Investigation of the Effects of Virtual Reality Training on Dual Task Performance, Balance and Gait on Patients With Chronic Stroke

Hacettepe University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2019年2月20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
30
试验地点
2
主要终点
10 meter walk test

研究概览

简要总结

This study evaluates the effects of virtual reality treatment in addition to robotic gait therapy on dual task performance, balance and gait in chronic stroke patients. Half of participants will attend virtual reality treatment in addition to robotic gait therapy for 12 sessions, while the other half will attend only robotic gait therapy for 12 sessions.

详细描述

Following stroke, motor disorders, balance disorders, falls, gait disturbances and cognitive disorders are frequently seen. In stroke rehabilitation, with the use of robots and virtual reality systems with conventional methods, it is aimed to increase patient's motivation, to check if exercise is effective, to provide objective evaluation data and to support the motor learning process and the use of these methods in the field of neurological rehabilitation is increasing.

Multi-task evaluations can be made with the virtual environments created by virtual reality applications and complex tasks.

The traditional approach to stroke rehabilitation is mainly focused on balance and gait training under single task conditions. In everyday life, people should not only have balance and mobility skills, but also have the ability to perform other cognitive and motor tasks with these skills. Therefore, traditional approaches are not sufficient for the individual to return to society after a stroke.

In this respect, this study was planned in order to examine the effects of frequently used virtual reality treatment in addition to robotic gait therapy on the dual task, balance and gait performance.

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 (Investigator)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteer to participate in the research
  • Stroke for the first time
  • To be able to walk independently before the disease
  • To score 3 or above in the functional ambulation classification
  • 6 months after stroke diagnosis
  • Not having open wounds
  • Severity of spasticity of the lower extremities to be 3 and below according to the Modified Asworth Scale
  • To score 24 or more in the Mini Mental State Examination

排除标准

  • Acute internal problems, additional neurological diseases, or orthopedic problems that might limit walking
  • To have received botulinum toxin treatment during 6 months before treatment or during treatment
  • To have stroke on both sides
  • To have neglect

研究组 & 干预措施

Virtual reality with robotic gait

Experimental

virtual reality treatment with robotic gait therapy 2 times for week by 6 weeks.

干预措施: virtual reality (Other)

Virtual reality with robotic gait

Experimental

virtual reality treatment with robotic gait therapy 2 times for week by 6 weeks.

干预措施: robotic gait (Other)

Robotic gait therapy only

Active Comparator

only robotic gait therapy 2 times for week by 6 weeks

干预措施: robotic gait (Other)

结局指标

主要结局

10 meter walk test

时间窗: change from baseline time at the end of 6 week

The time is measured after 10 meter walk completed

10 meter walk test with cognitive task

时间窗: change from baseline time at the end of 6 week

The time is measured after 10 meter walk with a cognitive task completed

10 meter walk test with motor task

时间窗: change from baseline time at the end of 6 week

The time is measured after 10 meter walk with a motor task completed

次要结局

  • Berg Balance Scale(change from baseline score at the end of 6 week)
  • Falls Efficacy Scale - International(change from baseline score at the end of 6 week)
  • Functional Ambulation Classification(change from baseline score at the end of 6 week)
  • Rivermead Mobility Index(change from baseline score at the end of 6 week)
  • Functional Gait Assessment(change from baseline score at the end of 6 week)
  • Mini Mental State Examination(change from baseline score at the end of 6 week)

研究者

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

Büşra Kayabınar

Lecturer

Hacettepe University

研究点 (2)

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