Clinical trial NCT03582397: Virtual Reality Mirror Therapy for Stroke
Official title: Virtual Reality Mirror Therapy for Upper Limb Rehabilitation Following Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Realiteer Corp.
First posted: 2018-07-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence
timeFrame: Up to 20 weeks.
measure: Initial Tolerance of System
timeFrame: Treatment Day 1
measure: Initial Perception of System Usability
timeFrame: Treatment Day 1
measure: Adverse Event Tracking
timeFrame: 20 weeks
measure: Montreal Cognitive Assessment
timeFrame: Baseline visit
measure: Change in tolerance of system
timeFrame: 20 Weeks
measure: Change in Perception of System Usability
timeFrame: 20 Weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke (arm/hand section)
timeFrame: Baseline study visit and following treatment completion, up to 20 weeks.
measure: Action Research Arm Test
timeFrame: Baseline study visit and following treatment completion, up to 20 weeks.
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Joel Stein, MD
role: PRINCIPAL_INVESTIGATOR
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