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.
1This trial is specifically for stroke patients who can't walk yet — given where I am in my recovery, would I be considered a non-walking stroke patient in the way this study defines it?
2The trial is measuring something called 'CyberKinetosis,' which sounds like it might be motion sickness or dizziness from the virtual reality component — how common or serious could that side effect be, and how would it be managed if it happened to me?
3Since this study has no assigned phase, it seems like it's primarily focused on whether patients can tolerate this robotic and VR combination rather than proving it improves walking — does that mean we don't yet know if it actually helps people walk again, and how does that compare to my current rehabilitation options?
4The rehabilitation involves both a robotic device and virtual reality at the same time — how physically and mentally demanding is that kind of session, and given my current condition, is my body ready for that type of combined therapy?
5Are there standard stroke rehabilitation programs I should consider first before enrolling in a tolerance study like this one, or could participating in this trial fit alongside my existing treatment plan?
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.