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临床试验/NCT04360460
NCT04360460已完成不适用

Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke

Loma Linda University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年12月3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
10
试验地点
1
主要终点
Motor Activity Log

研究概览

简要总结

This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.

详细描述

Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18-90 years old
  • •Hospitalized at Loma Linda East Campus Rehabilitation Hospital
  • •First time stroke patient
  • •Upper limb hemiparesis
  • •English-speaking
  • •Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb

排除标准

  • •Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device
  • •Patients with hemicraniectomy
  • •Current uncontrolled seizures
  • •Active infections requiring contact precautions
  • •Cognitively unable to participate
  • •Vision loss limiting ability to participate with VR therapy

研究组 & 干预措施

Experimental

Experimental

Virtual reality followed by translation into related functional tasks in a real life setting for 2 weeks + conventional therapies

干预措施: Immersive virtual reality + related functional translation into real-life (Other)

Control

Active Comparator

Virtual reality followed by translation into non-related functional tasks in a real life setting for 2 weeks + conventional therapies

干预措施: Immersive virtual reality + non-related translation into real-life (Other)

结局指标

主要结局

Motor Activity Log

时间窗: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)

ADL Self-Reported Questionnaire Amount Scale (0-5) 0 = Did not use my weaker arm (not used) 5 = Used my weaker arm as often as before the stroke (same as pre-stroke). How well scale (0-5) 0 - My weaker arm was not used at all for that activity (not used). 5 - The ability to use my weaker arm for that activity was as good as before the stroke (normal).

次要结局

  • Montreal Cognitive Assessment(Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks))
  • Modified Barthel's Index(Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks))
  • Fugl-Meyer Upper Extremity Assessment(Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks))
  • Functional Independence Measurement Score(Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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