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临床试验/NCT04215679
NCT04215679招募中不适用

Comparison of Three Dimensional Virtual Reality Therapy and Motor Imaging in Functional Recovery of Upper Extremity After Stroke

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年12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
招募中
入组人数
36
试验地点
1
主要终点
Action Reach Arm Test (ARAT)

研究概览

简要总结

Virtual reality applications in hemiplegia rehabilitation are gaining popularity. It is claimed that, apart from implementing a function, imagining that function can trigger synaptic connections.

详细描述

Although the effects of non-three-dimensional virtual reality and motor imagination on the brain have been investigated in a study, such comparison has not been made between the three-dimensional virtual reality and motor imagery.

Considering these situations, the aim of this study is to compare the effect of three-dimensional (immersive) virtual reality and motor imagery on upper extremity functional recovery after stroke.

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)

盲法说明

Participant will be evaluated at baseline, 6 weeks later by an another investigator who does not aware of groups.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed as stroke patient.
  • •Speaks, reads and writes in Turkish.
  • •Hand functions at 4, 5, 6 levels according to Brunnstrom.
  • •Mini mental test score to be at least
  • •Volunteer for participation.

排除标准

  • •Neurological, orthopedic problems other than stroke.
  • •To have motion sickness that cannot continue 3D application.
  • •Individuals neglecting the affected side

研究组 & 干预措施

Three-dimensional immersive virtual reality application

Experimental

25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose mini Mental State Examination (MMSE) scores equal or above the 25 will be included in this study. Oculus Rift and Leap motion will be used to create an immersive interactive environment. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks.

干预措施: Three-dimensional immersive virtual reality application (Other)

Motor imagery

Active Comparator

25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift and Leap motion will be used to create an immersive interactive environment. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks.

干预措施: Motor imagery (Other)

Conventional physiotherapy

Active Comparator

25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift and Leap motion will be used to create an immersive interactive environment. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks.

干预措施: Conventional physiotherapy (Other)

结局指标

主要结局

Action Reach Arm Test (ARAT)

时间窗: 6 weeks

This scale is scored between 0-57 points and consists of 4 headings: gross grip, fine grip, fingertip grip, and gross motion. Each part is calculated over 3 points. 3 points mean that the test is done in a normal way, 2 points show the difficulty and abnormally long time for doing it, 1 point means that individual can partially complete the test and 0 points can not complete the test. The higher the score, the better the level.

Jebsen Hand Function Test

时间窗: 6 weeks

The test consists of 7 subtitles and is an objective and standardized test. The test consists of 7 subtitles: "writing a standard sentence", "flipping 5 cards", "picking up small objects", "feeding simulation", "arranging backgammon checkers", "carrying large light objects" and "carrying large heavy objects". The score of the test is the completion time of the test and is recorded in seconds

次要结局

  • Stroke impact scale (SIS)(6 weeks)
  • Kinesthetic and visual imagery questionnaire(6 weeks)

研究者

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

Ramazan KURUL

Assistant Professor

Abant Izzet Baysal University

研究点 (1)

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