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NCT06053619
Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients
Conditions: Stroke, Central Nervous System Diseases
Sex: All
Ages: 35 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: University Hospital, Limoges
Location: CHU de Limoges Limoges
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06053619). StuddyBuddy aggregates publicly available trial information.