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Clinical Trials in France / NCT06053619
Recruiting Not applicable

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

NCT06053619 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-11-20
Last updated
2026-06-25

Condition(s) studied

StrokeCentral Nervous System Diseases

Investigational drug(s) / intervention(s)

GaitTrainer and Virtual Reality

GaitTrainer and Virtual Reality: Realization of Gait Trainer-assisted robot walking rehabilitation sessions without and with the addition of an immersive VR device. The proposed virtual stage will be a natural space (i.e. forest) of 360°. The subject will be able to explore the environment without moving. The created scene represents a straight path crossing a landscape composed of different natural elements. A fluid movement is obtained with the help of two sensors (trackers) of the HTC Vive device, placed at the level of the subject's feet. Moreover, thanks to these sensors the individual has a virtual representation of his lower limbs. Post-stroke patients will perform 3 conventional sessions (Gait Trainer alone) and 3 sessions with the immersive VR device (Gait Trainer + VR).

Study summary

The primary objective of this study is to evaluate the tolerance of the use of immersive virtual reality (VR) during robotic walking rehabilitation sessions by Gait Trainer (GT) in post-stroke patients.

Secondary objectives aim to evaluate the motivation to participate in VR sessions compared to conventional sessions, the participants' sense of presence within the virtual environment, and the usability of the rehabilitation device created. Finally, we will report the actual walking time and number of steps stroke patients take in VR sessions and conventional sessions.

Eligibility

Sex
ALL
Min age
35 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Hemiparesis following a first ischemic or hemorrhagic stroke; * subacute phase (15 days to 6 months); * Aged 35 to 75 years; * Non-walking subject (unable to walk 3 x 10 meters without human assistance or Functional Ambulation Classification ≤ 2); * Benefiting from robot-assisted walking rehabilitation in the readaptation and physical medecin department of the Limoges University Hospital; * Having the cognitive abilities to understand and follow simple verbal instructions (MMSE \< 24 or BDAE \< 2) * Be able to give informed consent to participate in this study. Exclusion Criteria: * Have neurological and psychiatric conditions, other than stroke; * Conditions contraindicating the use of virtual reality (e.g., epileptic disorders, major cerebellar syndrome). * Inability to evolve in a virtual environment (MSSQ-Short \> 26) * Patient with acute cardiovascular and respiratory disorders; * Patient who is subject to a legal protection measure or who is unable to give consent; * Person deprived of liberty * Person with high VR experience during the 5 years before stroke * pregnant woman, breastfeeding woman

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU de Limoges Limoges France Recruiting

More University Hospital, Limoges trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06053619 on ClinicalTrials.gov ↗ ← All trials in France