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

NCT ID: NCT06053619

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2025-09-11

Brief 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.

Detailed 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.

Conditions

Stroke; Central Nervous System Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GaitTrainer

This group of participants will benefit from 3 consecutive sessions of classic GaitTrainer without VR and then these same participants will benefit from 3 consecutive sessions of GaitTrainer with VR

Group Type: EXPERIMENTAL

GaitTrainer and Virtual Reality

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Limoges

Limoges, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Maxence COMPAGNAT, MD

Role: CONTACT

maxence.compagnat@chu-limoges.fr

555056518 ext. +33

Charles MORIZIO

Role: CONTACT

charles.morizio@chu-limoges.fr

Facility Contacts

Maxence COMPAGNAT, MD

Role: primary

maxence.compagnat@chu-limoges.fr

555056518 ext. +33

Charles MORIZIO

Role: backup

Other Identifiers

87RI23_0006 (RAVIS)

Identifier Type: -

Identifier Source: org_study_id