Virtual Reality Mirror Therapy for Stroke

NCT03582397 | Completed FDA Device

• 1 other identifier: AAAR5098
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (7)

• Adherence

  Percentage of intervention visits completed (full 30 minute period) with a higher percentage indicating stronger adherence.

  Up to 20 weeks.

• Initial Tolerance of System

  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

  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

  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

  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

  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

  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 Outcomes (2)

• Fugl-Meyer Assessment of Motor Recovery after Stroke (arm/hand section)

  Baseline study visit and following treatment completion, up to 20 weeks.

• Action Research Arm Test

  Baseline study visit and following treatment completion, up to 20 weeks.

Study Arms (1)

Experimental

EXPERIMENTAL

Subjects to receive virtual reality mirror therapy via WiseMind Software (Realiteer) 3x/week for 4 weeks.

Device: Virtual Reality Mirror Therapy

Interventions

Virtual Reality Mirror Therapy DEVICE

Virtual reality mirror therapy (WiseMind) developed by Realiteer and delivered via Oculus Rift virtual reality platform.

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Realiteer Corp.: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joel Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Simon Baruch Professor of Physical Medicine and Rehabilitation; Chair, Department of Rehabilitation and Regenerative Medicine

Model Details: This is an interventional pilot study with a pre-test/post-test design. All eligible subjects will receive the intervention. We plan to enroll up to 20 subjects, with the goal of having 10-12 evaluable subjects.

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: July 11, 2018
• Study Start: October 16, 2017
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the time of manuscript submission.
• Access Criteria: IPD was only shared with the publishing journal.

Locations

US (1)