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Immersive Virtual Reality for Stroke Motor Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03094650
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborators:
Ecole Polytechnique Fédérale de Lausanne
Clinique Romande de Readaptation
Information provided by (Responsible Party):
Mindmaze SA

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Stroke Motor Disorders Device: MindMotion PRO Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: The Use of Immersive Virtual Reality for Upper Limb Neurorehabilitation in Stroke Survivors
Actual Study Start Date : February 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094650


Locations
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Switzerland
Center for Neuroprosthetics-Valais (EPFL) at Clinique Romande de Réadaptation
Sion, Valais, Switzerland
Sponsors and Collaborators
Mindmaze SA
Ecole Polytechnique Fédérale de Lausanne
Clinique Romande de Readaptation
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mindmaze SA
ClinicalTrials.gov Identifier: NCT03094650    
Other Study ID Numbers: MindMaze-2015-CT01
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mindmaze SA:
stroke
neurorehabilitation
virtual reality
rehabilitation dose
motor rehabilitation
Additional relevant MeSH terms:
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Stroke
Motor Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mental Disorders