NCT06053619

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

September 19, 2023

Last Update Submit

January 16, 2025

Conditions

StrokeCentral Nervous System Diseases

Keywords

StrokeVirtual RealityStroke RehabilitationRoboticGait Trainer

Outcome Measures

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).

    2 weeks

Secondary Outcomes (5)

  • Motivation to participate in immersive VR sessions

    2 weeks

  • Evaluation of the sense of presence within the Virtual environmet

    2 weeks

  • usability of the immersive VR rehabilitation device

    2 weeks

  • Assessment of walking time

    2 weeks

  • Assessment of number of steps

    2 weeks

Study Arms (1)

GaitTrainer

EXPERIMENTAL

This group of participants will benefit from 3 consecutive sessions of classic GaitTrainer without VR and then these same participants will benefit from 3 consecutive sessions of GaitTrainer with VR

Other: GaitTrainer and Virtual Reality

Interventions

GaitTrainer and Virtual RealityOTHER

Realization 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).

GaitTrainer

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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;
  • 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.

You may not qualify 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
  • Person with high VR experience during the 5 years before stroke
  • pregnant woman, breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Limoges

Limoges, 87042, France

RECRUITING

MeSH Terms

Conditions

StrokeCentral Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Maxence COMPAGNAT, MD

CONTACT

555056518maxence.compagnat@chu-limoges.fr

Charles MORIZIO

CONTACT

charles.morizio@chu-limoges.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

November 20, 2023

Primary Completion

September 11, 2025

Study Completion

September 11, 2025

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)