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

Phase

N/A

Condition

Stroke

Neurologic Disorders

Cerebral Ischemia

Treatment

GaitTrainer and Virtual Reality

Clinical Study ID

NCT06053619

87RI23_0006 (RAVIS)

Ages 35-75
All Genders

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 Criteria

Inclusion

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 orFunctional Ambulation Classification ≤ 2);
Benefiting from robot-assisted walking rehabilitation in the readaptation andphysical 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

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 giveconsent;
Person deprived of liberty
Person with high VR experience during the 5 years before stroke
pregnant woman, breastfeeding woman

Study Design

GaitTrainer and Virtual Reality

November 20, 2023

September 11, 2025

Study Description

Robotic Assisted Gait Therapy using the GT has been shown to be effective in restoring gait to non-walking stroke patients. However, GaitTrainer rehabilitation sessions can result in fatigue, sling attachment discomfort, which can limit the duration, intensity and participation of patients. Immersive Virtual Reality (VR) via visio helmet is an innovative and playful approach that allows rehabilitation to focus on specific tasks, such as walking in controlled and environmentally friendly environments. Coupled with robotic assistance, it could promote patient adherence and active participation thanks to the presence of bio-feedback and its playful aspect. However, the GT has never been associated with a walking activity simulated by a VR system. VR can lead to adverse effects (i.e., cyberkinetosis) such as dizziness, nausea or headaches. Thus, it seems necessary to observe the tolerance of the virtual environment immersion during GT assisted walking rehabilitation sessions in stroke patients.

This protocol involves the recruitment of non-walking stroke participants who are being rehabilitated in a Physical Medicine and Rehabilitation (PMR) department and receiving Gait Trainer-assisted rehabilitation. The intervention will consist of Gait Trainer-assisted robotic walking rehabilitation sessions with and without the addition of an immersive VR device. Post-stroke patients will complete 3 conventional sessions (Gait Trainer alone) and 3 sessions with the VR device.

Connect with a study center

CHU de Limoges
Limoges, 87042
France
Active - Recruiting

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