Clinical trial NCT06053619: Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients
Official title: Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Central Nervous System Diseases
Keywords: Stroke
Virtual Reality
Stroke Rehabilitation
Robotic
Gait Trainer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 attachment discomfort, which can limit the duration, intensity and participation of patients. Immersive Virtual Reality (VR) via visio helmet is an innovative and playful approach that allows rehabilitation to focus on specific tasks, such as walking in controlled and environmentally friendly environments. Coupled with robotic assistance, it could promote patient adherence and active participation thanks to the presence of bio-feedback and its playful aspect. However, the GT has never been associated with a walking activity simulated by a VR system. VR can lead to adverse effects (i.e., cyberkinetosis) such as dizziness, nausea or headaches. Thus, it seems necessary to observe the tolerance of the virtual environment immersion during GT assisted walking rehabilitation sessions in stroke patients.

This protocol involves the recruitment of non-walking stroke participants who are being rehabilitated in a Physical Medicine and Rehabilitation (PMR) department and receiving Gait Trainer-assisted rehabilitation. The intervention will consist of Gait Trainer-assisted robotic walking rehabilitation sessions with and without the addition of an immersive VR device. Post-stroke patients will complete 3 conventional sessions (Gait Trainer alone) and 3 sessions with the VR device.

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

Primary outcomes:
measure: CyberKinetosis
timeFrame: 2 weeks
Secondary outcomes:
measure: Motivation to participate in immersive VR sessions
timeFrame: 2 weeks
measure: Evaluation of the sense of presence within the Virtual environmet
timeFrame: 2 weeks
measure: usability of the immersive VR rehabilitation device
timeFrame: 2 weeks
measure: Assessment of walking time
timeFrame: 2 weeks
measure: Assessment of number of steps
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
References: