Virtual Reality Mirror Therapy for Stroke

October 10, 2019 updated by: Joel Stein, MD, Columbia University

Virtual Reality Mirror Therapy for Upper Limb Rehabilitation Following Stroke

Mirror box therapy is a treatment option that has shown promise for people with difficulty moving their arm after a brain injury, such as stroke. During mirror box therapy, people place their affected arm inside a box, where they are unable to see it. They then focus their attention on the outside of the box, which has been fitted with a mirror. The mirror reflects the movements of their intact hand and makes it appear that both hands are moving normally. Research has shown that this type of therapy can help people recover some use of the arm.

This study is designed to examine a new type of treatment, which uses a virtual reality headset (Oculus Rift) to recreate this effect in a virtual environment. Up to twenty people who have had a stroke and now have difficulty using an arm (Fugl-Meyer Upper Extremity range 10-50) will be asked to come in for four weeks of treatment, during which they will perform a set of movements and games using the virtual reality platform, while focusing on the image of their affected arm. Treatment will include two fifteen minute sessions, three times/week for a period of four weeks. Participants will complete pre-testing, which will provide a baseline measure of performance, and post-testing, to see if the treatment has been well-tolerated and has had any impact on their motor performance.

This research is important because it may demonstrate the usefulness of a new treatment method for people who have suffered a stroke, or generally demonstrate that virtual reality platforms may be useful treatment tools for stroke survivors. It may also provide a relatively low-cost and motivating rehabilitation tool for use in the hospital or home environment outside of therapy hours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Up to twenty stroke survivors with upper extremity impairment will be enrolled in this study. After subjects have been consented, they will undergo screening to ensure they meet inclusion/exclusion criteria. This will include the Motion Sickness Susceptibility Questionnaire (Short Form). Demographics will be recorded including: relevant medical history (including any contraindications to engage in virtual reality therapy), age, gender, hand dominance, and location and date of stroke. The Montreal Cognitive Assessment will be performed to assess feasibility of the intervention for subjects of varying cognitive levels. Subjects who meet study requirements and score between 10-50 points on the Fugl-Meyer Assessment of Motor Recovery after Stroke (Arm/hand section) will complete pre-testing using the Action Research Arm Test (ARAT).

Virtual reality mirror therapy will be delivered via the commercially available Oculus Rift gaming system, using novel software (WiseMind), developed by Realiteer. Subjects will complete treatment in a designated space clear of distractions and physical objects. They will remain seated in a chair throughout treatment.

A member of the research team will configure the system, entering in the subject's skin tone, height, and weight to enable the system to best approximate their physical form. The subject will then don the Oculus Rift headset, which will block external visual stimuli and provide an immersive visual environment for training. Researchers will position game controller using a wrist strap to ensure patient safety. Researchers will orient subjects to the training environment and ensure patient comfort with the system before initiating treatment. Patients will complete a System Usability Scale and the Simulator Sickness Questionnaire on the first and final treatment day to assess system tolerance. Adherence and adverse events will also be recorded throughout the trial.

The WiseMind software will allow subjects to view an approximation of their upper limbs. As the subject moves their arms, the system will detect these movements and mimic them through the headset, so the patient envisions a virtual limb moving as their own. Training will incorporate range of motion exercises, virtual reality games that require reaching, and interacting with functional objects in the virtual environment.

An occupational therapist, physical therapist or exercise physiologist from the research team will run all treatment sessions. Training will be immediately terminated if the subject feels excessively queasy or requests termination for any reason. Training will consist of two, fifteen minute sessions, 3x/week for four weeks.

At the completion of treatment, subjects will repeat the Fugl-Meyer and ARAT assessments to determine if improvements have been made in motor performance.

Study Type

Interventional

Enrollment (Actual)

11

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

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of one or more ischemic or hemorrhagic stroke
  • Reduced use/weakness of the arm
  • Ability to follow two-step commands
  • Ability to provide informed consent
  • Fugl-Meyer Arm/Hand score between 10-50

Exclusion Criteria:

  • Serious visual or visual-perceptual deficits, neuropsychological impairments, or orthopedic conditions that would prevent participation in the protocol as determined by the treatment team
  • Concurrent participation in another study protocol related to motor function after stroke
  • High susceptibility to motion sickness, as evidence by a score of 26 or greater on the Motion Sickness Susceptibility Questionnaire Short-Form (90th percentile)
  • Receiving ongoing occupational or physical therapy for upper limb motor retraining

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Subjects to receive virtual reality mirror therapy via WiseMind Software (Realiteer) 3x/week for 4 weeks.
Device: Virtual Reality Mirror Therapy
Virtual reality mirror therapy (WiseMind) developed by Realiteer and delivered via Oculus Rift virtual reality platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: Up to 20 weeks.
Percentage of intervention visits completed (full 30 minute period) with a higher percentage indicating stronger adherence.
Up to 20 weeks.
Initial Tolerance of System
Time Frame: Treatment Day 1
Simulator sickness questionnaire. Self-report checklist to screen for adverse symptoms following simulations. Scores range from 0-26, with higher scores indicating increased physical symptoms and poorer tolerance for the intervention.
Treatment Day 1
Initial Perception of System Usability
Time Frame: Treatment Day 1
System Usability Scale: Subject questionnaire to assess ease of use of the system. Scores range from 0-100, with higher scores indicating greater usability.
Treatment Day 1
Adverse Event Tracking
Time Frame: 20 weeks
Researchers to track observed or reported adverse events related to the intervention. Higher number of adverse events indicates poorer tolerance of intervention.
20 weeks
Montreal Cognitive Assessment
Time Frame: Baseline visit
Cognitive screening tool. Scores range from 0-30, with a score of 26 or above indicating "normal" cognition. This will be used to ascertain feasibility of the intervention for patients of various cognitive levels.
Baseline visit
Change in tolerance of system
Time Frame: 20 Weeks
Simulator Sickness Questionnaire Scores following 1st treatment session, compared to 12th treatment session. Self-report checklist to screen for adverse symptoms following simulations. Scores range from 0-26, with higher scores indicating increased physical symptoms and poorer tolerance for the intervention.
20 Weeks
Change in Perception of System Usability
Time Frame: 20 Weeks
System Usability Scale: Subject questionnaire to assess ease of use of the system. Scores range from 0-100, with higher scores indicating greater usability. Score on final treatment day (session 12) to be compared with score from treatment session 1.
20 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment of Motor Recovery after Stroke (arm/hand section)
Time Frame: Baseline study visit and following treatment completion, up to 20 weeks.
Standardized test of upper extremity motor function following stroke. Scores range from 0-66 for this section of the Fugl-Meyer, with higher scores indicating better motor function.
Baseline study visit and following treatment completion, up to 20 weeks.
Action Research Arm Test
Time Frame: Baseline study visit and following treatment completion, up to 20 weeks.
Standardized test of hand and arm function. Scores range from 0-57, with higher scores indicating enhanced motor performance.
Baseline study visit and following treatment completion, up to 20 weeks.

Collaborators and Investigators

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

Sponsor

Columbia University

Collaborators

Realiteer Corp.

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)

October 16, 2017

Primary Completion (Actual)

July 27, 2018

Study Completion (Actual)

July 27, 2018

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

July 9, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

October 14, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR5098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data (IPD) will be shared with the publishing journal. Baseline scores, post-intervention scores, and percent change in scores will be provided for the Fugl Meyer and Action Research Arm Test. Participant characteristics will be listed in the publication including, age, sex, time since stroke, and scores on the baseline Fugl Meyer, Montreal Cognitive Assessment, and Motion Sickness Susceptibility Questionnaire.

IPD Sharing Time Frame

At the time of manuscript submission.

IPD Sharing Access Criteria

IPD was only shared with the publishing journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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