Tolerance Study of Robotic-Assisted Virtual Reality Walking Rehabilitation for Non-Walking Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorUniversity Hospital, Limoges
About this trial
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
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
GaitTrainer and Virtual Reality
Other interventionRealization of Gait Trainer-assisted robot walking rehabilitation sessions without and with the addition of an immersive VR device. The proposed virtual stage will be a natural space (i.e. forest) of 360°. The subject will be able to explore the environment without moving. The created scene represents a straight path crossing a landscape composed of different natural elements. A fluid movement is obtained with the help of two sensors (trackers) of the HTC Vive device, placed at the level of the subject's feet. Moreover, thanks to these sensors the individual has a virtual representation of his lower limbs. Post-stroke patients will perform 3 conventional sessions (Gait Trainer alone) and 3 sessions with the immersive VR device (Gait Trainer + VR).
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: GaitTrainerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CyberKinetosis
cyberkinetosis assessed by the Simulator Sickness Questionary (SSQ). This is a 16-item questionary evaluating different symptoms on a scale from 0 (not at all) to 4 (severely).
Time frame
2 weeksSecondary outcomes
1
Motivation to participate in immersive VR sessions
Motivation to participate in walking rehabilitation sessions will be assessed using the Intrinsic Motivation Inventory (IMI). This is a multidimensional questionnaire used to estimate motivation to perform specific activities. The various items are evaluated on a Likert-type scale ranging from 1 to 7. The 4 subscales we'll be using are interest/pleasure, effort, usefulness and pressure/tension.
Time frame
2 weeks2
Evaluation of the sense of presence within the Virtual environmet
the feeling of presence in the virtual environment will be assessed by the Presence Questionnaire (PQ). It consists of 19 items designed to assess the feeling of spatial presence. Each question uses a Likert-type scale ranging from 1 to 7.
Time frame
2 weeks3
usability of the immersive VR rehabilitation device
The usability of the rehabilitation device will be assessed using the System Usability Scale (SUS). This is a 10-item scale giving a final score out of 100. The higher the score, the greater the perceived usability of the system.
Time frame
2 weeks4
Assessment of walking time
We will report the effective walking time (in minutes) during the sessions with and without the VR device.
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov