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New treatment option for Stroke
Official title Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients
ClinicalTrials.gov ID: NCT06053619
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 75
You may be able to join if
- 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;
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Limoges, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Limoges, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.