Immersive Virtual Reality for Stroke Motor Rehabilitation

March 23, 2017 updated by: Mindmaze SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Valais
      • Sion, Valais, Switzerland
        • Center for Neuroprosthetics-Valais (EPFL) at Clinique Romande de Réadaptation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MindMotion PRO
The training sessions consist of virtual reality based rehabilitation exercises using the MindMotion PRO device.
Device: MindMotion PRO
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 weeks
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.
5 weeks
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)
At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Independence Measure (FIM)
Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in kinematic metrics/goniometry (active range of motion).
Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in Modified Medical Research Council Scale (mMRCS)
Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in Visual Analog Scale (VAS) for Pain
Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
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
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mindmaze SA

Collaborators

Ecole Polytechnique Fédérale de Lausanne
Clinique Romande de Readaptation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MindMaze-2015-CT01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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