CHU de Limoges
Limoges, 87042, France
Location status: Recruiting
Location contact
Charles MORIZIO
CONTACT
Maxence COMPAGNAT, MD
CONTACT
555056518 ext. +33
Maxence COMPAGNAT, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06053619
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.
Interested in participating?
Request Info35 year–75 year
All sexes
Interventional
Not applicable
Limoges, 87042, France
Location status: Recruiting
Charles MORIZIO
CONTACT
Maxence COMPAGNAT, MD
CONTACT
555056518 ext. +33
Maxence COMPAGNAT, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 2 weeks
cyberkinetosis assessed by the Simulator Sickness Questionary (SSQ). This is a 16-item questionary evaluating different symptoms on a scale from 0 (not at all) to 4 (severely).
Time frame: 2 weeks
Motivation to participate in walking rehabilitation sessions will be assessed using the Intrinsic Motivation Inventory (IMI). This is a multidimensional questionnaire used to estimate motivation to perform specific activities. The various items are evaluated on a Likert-type scale ranging from 1 to 7. The 4 subscales we'll be using are interest/pleasure, effort, usefulness and pressure/tension.
Time frame: 2 weeks
the feeling of presence in the virtual environment will be assessed by the Presence Questionnaire (PQ). It consists of 19 items designed to assess the feeling of spatial presence. Each question uses a Likert-type scale ranging from 1 to 7.
Time frame: 2 weeks
The usability of the rehabilitation device will be assessed using the System Usability Scale (SUS). This is a 10-item scale giving a final score out of 100. The higher the score, the greater the perceived usability of the system.
Time frame: 2 weeks
We will report the effective walking time (in minutes) during the sessions with and without the VR device.
Time frame: 2 weeks
We will report the number of steps during the sessions with and without the VR device.
Contact information is provided by the study sponsor or research team.
University Hospital, Limoges
Other
Acronym: RAVIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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