Skip to main content
OpenTrials
Completed

NCT Number: NCT03094650

Immersive Virtual Reality for Stroke Motor Rehabilitation

The present study aims at investigating (i) the feasibility in chronic stroke of using a dedicated virtual reality (VR) based system that embeds real-time 3D motion capture and embodied visual feedback to deliver functional exercises designed for training of impaired upper limb motor skills, (ii) whether chronic stroke survivors improve in functional outcomes in the upper limb when exposed to intensive VR-based therapy, and (iii) safety and tolerance to such a technology. The investigators hypothesize that intensive VR-based rehabilitation may lead to high rehabilitation doses and functional improvement in chronic stroke.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mental Disorders Motor Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Neuroprosthetics-Valais (EPFL) at Clinique Romande de Réadaptation

Sion, Valais, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic or hemorrhagic minor-to-moderate (0<NIHSS<16) stroke with hemiparesis and experiencing arm motor difficulties
  • At least 6 months after stroke incident
  • Maximum 4 on the Medical Research Council Scale (MRCS) for shoulder elevation and elbow flexion/extension
  • 18 years and older
  • First ever stroke

Exclusion criteria

  • Participating in another movement treatment study at the time of the present study
  • Severe cognitive impairment (Mini Mental Status Examination score < 18 points)
  • Orthopedic impairment or visual disorders limiting the treatment
  • Unable to give informed consent form
  • Risk of epileptic seizures

Treatment and study plan

MindMotion PRO

Device

Patients will receive five weeks of therapy with 2 sessions (minimum) per week lasting for 45-60 minutes each minimum. The training sessions are based on the MindMotion PRO's virtual reality exercises.

Primary outcomes

  1. Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)

    Time frame: 5 weeks

    Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)

  2. Training intensity: number of goal-directed movements per minute of effective training time.

    Time frame: 5 weeks

    Training intensity: number of goal-directed movements per minute of effective training time.

  3. Change in Upper limb function assessed with Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

    Time frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)

    Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Secondary outcomes

  1. Change in Functional Independence Measure (FIM)

    Time frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)

  2. Change in kinematic metrics/goniometry (active range of motion).

    Time frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)

  3. Change in Modified Medical Research Council Scale (mMRCS)

    Time frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)

  4. Change in Visual Analog Scale (VAS) for Pain

    Time frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)

  5. Safety and Acceptance of Technology assessed with a questionnaire

    Time frame: 5 weeks

    Participants will answer a questionnaire to evaluate following aspects:

    • Tolerance to VR intervention
    • Adverse event monitoring
    • Self-evaluation
    • Acceptance of technology
    • Motivation

Sponsors and collaborators

Lead sponsor

Mindmaze SA

Industry

Collaborators

  • Clinique Romande de Readaptation
  • Ecole Polytechnique Fédérale de Lausanne

Registry information

Official study title

The Use of Immersive Virtual Reality for Upper Limb Neurorehabilitation in Stroke Survivors

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 29, 2017
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.