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Clinical Trials/NCT06053970
NCT06053970
Not yet recruiting
Not Applicable

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

FondationbHopale1 site in 1 country20 target enrollmentOctober 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke Rehabilitation
Sponsor
FondationbHopale
Enrollment
20
Locations
1
Primary Endpoint
Displacement speed of the center of pressure (in mm.s-1)
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2023
End Date
October 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
FondationbHopale
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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)

Study Sites (1)

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