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临床试验/NCT06053970
NCT06053970尚未招募不适用

Prospective, Randomized, Exploratory Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Subacute Stroke Rehabilitation Setting

FondationbHopale2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年10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
20
试验地点
2
主要终点
Displacement speed of the center of pressure (in mm.s-1)

研究概览

简要总结

This is an interventional, prospective, randomized, monocentric study designed to develop medical knowledge.

Virtual reality is increasingly used in rehabilitation. The aim of virtual reality is to investigate motor interactions in a fictitious, configurable environment, in order to train specific functions and transpose improvements into everyday life.

The main objective of this study is to investigate the influence of different moving virtual scenes on the general spatiotemporal parameters of pressure centers, in a sub-acute stroke rehabilitation context.

This would help health professionals to assess the most suitable VR exercise in function of patient's difficulties.

During this study, patient movements while viewing 8 different virtual reality scenes will be recorded using a motion platform during a single session.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: over 18
  • Adult patient in rehabilitation stay (day or full hospitalization) following a first stroke less than 6 months old.
  • One of the rehabilitation objectives is to improve balance
  • Ability to understand exercise instructions
  • Ability to stand for at least one minute with eyes closed, safely and without technical assistance
  • Ability to walk at least with technical assistance and/or supervision
  • Patient having given their informed consent
  • Patient affiliated to a social security scheme
  • Non -inclusion criteria :
  • Patients with epilepsy, controlled or not
  • Patients undergoing rehabilitation following a stroke in the posterior fossa
  • Known history of vestibular or cerebellar balance disorders
  • Patients with orthopedic or traumatological impairment preventing stabilometric measurement on a force platform without footwear
  • Patient under legal protection measure
  • Severe phasic disorders that may prevent the expression of the will to stop viewing virtual scenes or to respond to numerical scales
  • Pregnant or breastfeeding woman
  • Known history of motion sickness
  • Patient participating or having participated in the balance rehabilitation program with virtual reality within the rehabilitation center during their stay

排除标准

  • Cyberkinetosis represented by a score greater than or equal to 15 on the Fast Motion Sickness scale
  • Poor tolerance for wearing a virtual reality headset
  • Significant visual impairment preventing the perception of the stimulus visual

结局指标

主要结局

Displacement speed of the center of pressure (in mm.s-1)

时间窗: During the procedure (virtual reality session).

Displacement speed of the center of pressure will be recorded on a force platform under different conditions: * Eyes open with VR headset simulating a static environment * Eyes closed with VR helmet off * In 8 VR conditions simulating movement (in random order)

Total length of pressure center displacement (in mm)

时间窗: During the procedure (virtual reality session).

Length of pressure will be recorded on a force platform under different conditions: * Eyes open with VR headset simulating a static environment * Eyes closed with VR helmet off * In 8 VR conditions simulating movement (in random order)

次要结局

未报告次要终点

研究者

发起方
FondationbHopale
申办方类型
Other
责任方
Sponsor

研究点 (2)

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