Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke… (NCT06053619) | Clinical Trial Compass
RecruitingNot Applicable
Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients
France30 participantsStarted 2023-11-20
Plain-language 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.
Who can participate
Age range
35 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.