StrokeRAVISNCT06053619
Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients
A study testing GaitTrainer and Virtual Reality in people with Stroke and Central Nervous System Diseases, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke, Central Nervous System Diseases
- What is being tested?
- GaitTrainer and Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2023to 11 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Charles MORIZIO contact
France1 site, 1 recruiting
- Recruiting
CHU de Limoges
Limoges, 87042
Maxence COMPAGNAT, MD, 555056518 ext. +33, maxence.compagnat@chu-limoges.fr
Charles MORIZIO
About this study
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.
Read the 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
- Being tested
- GaitTrainer and Virtual Reality
- Keywords
- Stroke, Virtual Reality, Stroke Rehabilitation, Robotic, Gait Trainer
- Medical subject headings
- Stroke, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaitTrainer and Virtual RealityOther
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 group | Role | What they receive |
|---|---|---|
| GaitTrainer | Experimental | 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 Receives: Other: GaitTrainer and Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
CyberKinetosis
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).
Measured: 2 weeks
Secondary outcomes (5)
Motivation to participate in immersive VR sessions
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.
Measured: 2 weeks
Evaluation of the sense of presence within the Virtual environmet
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.
Measured: 2 weeks
usability of the immersive VR rehabilitation device
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.
Measured: 2 weeks
Assessment of walking time
We will report the effective walking time (in minutes) during the sessions with and without the VR device.
Measured: 2 weeks
Assessment of number of steps
We will report the number of steps during the sessions with and without the VR device.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start20 Nov 2023
- Primary completion11 Mar 2027 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053619
- Sponsor's protocol ID
- 87RI23_0006 (RAVIS)
- Acronym
- RAVIS
- Status last verified
- Jun 2026
- First submitted
- 19 Sep 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients
- ClinicalTrials.gov ID
- NCT06053619
- Acronym / sponsor ID
- RAVIS / 87RI23_0006 (RAVIS)
- Conditions
- Stroke, Central Nervous System Diseases
- Keywords
- Stroke, Virtual Reality, Stroke Rehabilitation, Robotic, Gait Trainer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 11 Mar 2027 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GaitTrainer | Experimental | Other: GaitTrainer and Virtual RealityThis 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 |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaitTrainer and Virtual RealityRealization 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). | Other | GaitTrainer |
Primary outcome
CyberKinetosis
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).
5 secondary outcomes
Motivation to participate in immersive VR sessions
Time frame: 2 weeks
Evaluation of the sense of presence within the Virtual environmet
Time frame: 2 weeks
usability of the immersive VR rehabilitation device
Time frame: 2 weeks
Assessment of walking time
Time frame: 2 weeks
Assessment of number of steps
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles MORIZIO contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GaitTrainer and Virtual Reality in people with Stroke and Central Nervous System Diseases, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxence COMPAGNAT, MD (555056518 ext. +33, maxence.compagnat@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CyberKinetosis (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.