Actively Recruiting

Phase Not Applicable
Age: 35Years - 75Years
All Genders
ID06053619

Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients

Led by University Hospital, Limoges · Updated on 2025-01-17

30

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how well non-walking stroke patients tolerate using immersive virtual reality (VR) during robotic walking rehabilitation sessions with the Gait Trainer (GT). The study aims to understand if adding VR can improve motivation, sense of presence, and usability compared to conventional rehabilitation sessions without VR. The research also looks at walking activity, including actual walking time and the number of steps taken during both VR and traditional sessions. Participants will undergo six rehabilitation sessions: three conventional sessions using the Gait Trainer alone, and three sessions combining the Gait Trainer with an immersive VR device. The VR environment simulates a natural space like a forest in 360 degrees, allowing patients to explore without moving, with virtual representations of their lower limbs tracked by sensors on their feet. This setup aims to create an engaging and controlled walking experience. During the study, participants will be monitored for tolerance to VR-related effects such as dizziness, nausea, or headaches, known as cyberkinetosis, over a two-week period. Researchers will assess motivation, presence in the VR environment, usability of the device, and walking performance. Participants' cognitive abilities and consent will be confirmed before involvement, and safety will be closely observed throughout the rehabilitation sessions.

CONDITIONS

Official Title

Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients

Who Can Participate

Age: 35Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hemiparesis following a first ischemic or hemorrhagic stroke
  • Stroke in the subacute phase (15 days to 6 months)
  • Aged between 35 and 75 years
  • Unable to walk 3 times 10 meters without human assistance or Functional Ambulation Classification 2 or less
  • Receiving robot-assisted walking rehabilitation in the Physical Medicine and Rehabilitation department of Limoges University Hospital
  • Cognitive ability to understand and follow simple verbal instructions (MMSE < 24 or BDAE < 2)
  • Able to give informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Neurological or psychiatric conditions other than stroke
  • Conditions that prevent use of virtual reality (e.g., epilepsy, major cerebellar syndrome)
  • Inability to adapt to a virtual environment (MSSQ-Short > 26)
  • Acute cardiovascular or respiratory disorders
  • Subject to legal protection measures or unable to give consent
  • Person deprived of liberty
  • High virtual reality experience in the 5 years before stroke
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de Limoges

Limoges, France, 87042

Actively Recruiting

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Research Team

M

Maxence COMPAGNAT, MD

C

Charles MORIZIO

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients | DecenTrialz