Status:
RECRUITING
Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients
Lead Sponsor:
University Hospital, Limoges
Conditions:
Stroke
Central Nervous System Diseases
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief 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 patient...
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 at...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 11 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06053619
Start Date
November 20 2023
End Date
September 11 2025
Last Update
January 17 2025
Active Locations (1)
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1
CHU de Limoges
Limoges, France, 87042