Effectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity Rehabilitation

Study Overview
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Brief Summary
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The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group equating the dose of in-person therapy. Individuals with chronic stroke will be randomized to one of four different interventions: (1) traditional clinic-based CI therapy (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy (5 therapist/client contact hours in the clinic and 15 hours of independent game play at home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist contact via telerehabilitation (5 therapist/client contact hours in the clinic, 2.6 therapist contact hours via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard occupational therapy (OT) / physical therapy (PT). After 6-month follow-up, individuals assigned to standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone application of the rehabilitation game without additional therapist contact).

Detailed Description
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Detailed study description published in BMC Neurology (2017).

Official Title
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Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): A Multi-center Comparative Effectiveness Trial of In-home Gamified Constraint-induced Movement Therapy for Rehabilitation of Chronic Upper Extremity Hemiparesis.

Conditions
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Stroke, Hemiparesis

Intervention / Treatment
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* Behavioral: Traditional CI Therapy
* Behavioral: Gaming CI Therapy
* Behavioral: Gaming CI Therapy with Additional Contact via Video Conference
* Behavioral: Traditional Occupational Therapy/Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males, females, or any gender identity 18 years of age or older Experienced a stroke resulting in mild-to-moderate hemiparesis at least six months prior to enrollment (suggested range of motion (ROM) criteria includes: 45° shoulder abduction and flexion, 20° elbow extension, 20° wrist extension, and 10° extension of thumb and finger) Have preserved ability to comprehend and participate in basic elements of the therapy Exclusion Criteria: Concurrent participation in other experimental trials for motor dysfunction treatment Receiving Botox therapy currently or in the past 3 months Have medical conditions that would place volunteers at higher risk of adverse events (e.g., renal disease, frailty, pregnancy, dementia, severe pain, end-stage/degenerative diseases) Have received intensive upper-extremity rehabilitation in the chronic phase post-stroke

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional CI Therapy<br>Participants will receive a 35-hour dose of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals. | Behavioral: Traditional CI Therapy<br>* Intensive in-person therapy for upper extremity hemiparesis.<br>|
| Active Comparator: Gaming CI Therapy<br>15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life. | Behavioral: Gaming CI Therapy<br>* Intensive remote (via video game) therapy for upper extremity hemiparesis.<br>|
| Active Comparator: Gaming CI Therapy with Additional Contact via Video Conference<br>This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period. | Behavioral: Gaming CI Therapy with Additional Contact via Video Conference<br>* Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.<br>|
| Active Comparator: Traditional Occupational Therapy/Physical Therapy<br>Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on activities of daily living (ADLs) with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system. | Behavioral: Traditional Occupational Therapy/Physical Therapy<br>* Traditional in-person therapy focusing on the rehabilitation of the upper extremity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test | Assesses the time to complete 15 standardized tasks (e.g., folding a towel, stacking checkers, placing hand on top of a box). Items that cannot be accomplished score 120 seconds. Times are natural log transformed to reflect proportional improvement (approximate % change) and correct for skew. On the log transformed scale, -.22 reflects normal ability, 4.79 = can't accomplish task. For improvement in mean log transformed performance time, -4.79 = best possible improvement, 0 = no improvement, positive scores = worsening. A proportional improvement of 16% (mean log transformed performance time change = -.17) is considered clinically meaningful. | 0 to 1 months | 
| Motor Activity Log Quality of Movement Scale | Assessment evaluates the amount and quality of everyday arm use. The scale consists of 28 activities of daily living (e.g., washing hands, drinking from a cup). Participants self-report on an 11-point scale (0-5 with half-point increments, 0=not attempted to 5=attempted with normal movement). The total score on the measure reflects the mean of the individual item scores. A change of 1.0 on the scale is considered clinically meaningful. | 0 to 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neuro-Quality of Life (Neuro-QOL) | Computerized adaptive assessment on several domains of quality of life: sleep, mobility, positive affect and well-being, fatigue, satisfaction with social roles, cognitive function, anxiety, and communication. Neuro-QOL uses a T score which has a mean of 50 and SD of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a higher score reflects more of what is being measured. Scores are reported as mean T-scores across the assessed domains. Positive changes indicate an improvement. | 0 to 1 months | 
| Bilateral Activity Monitors | Devices to monitor upper extremity movement are worn throughout treatment. The devices count movements made with each arm, defined as an acceleration of 2g for at least 500 ms. The ratio of more affected to less affected arm use is then calculated for each treatment day. The best linear fit trajectory for each participant is calculated after removal of outliers. The treatment change reported here reflects the difference between the best-fit-line at post-treatment and the best-fit-line at pre-treatment. Positive change indicates improvement. | 0 to 1 month | 
| Change in Brief Kinesthesia Test (BKT) | This measures was intended to measure proprioception in the upper extremity; however, performance on the measure is also known to be adversely affected by motor impairment. The experimenter guides individuals along movement trajectories between 2 and 9 inches with their vision obscured. They are then asked to reproduce the movement trajectories. The summed difference between the desired and produced trajectory endpoints in cm is reported. A negative change indicates an improvement. | 0 to 1 months | 
| Semmes-Weinstein Monofilament Test | Sensory evaluator of touch sensation. Units are the log transformed grams of pressure detected by the index finger of the paretic hand. Scores range from -1.8 to 5.7. Smaller scores indicate better sensation. Negative change indicates improvement. | 0 to 1 months | 
| 9 Hole Peg Test | Assessment to measure upper extremity distal motor function. The assessment measures the time to place 9 pegs into grooves on a board. Due to the inability of a majority of the participants to place all 9 pegs during the 120 seconds allotted for the test, performance was transformed into a rate metric to reduce floor effects. The outcome is expressed as change in the number of pegs per minute. | 0 to 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constraint-induced movement therapy, gaming, virtual reality, upper extremity, CI therapy, rehabilitation, stroke, hemiparesis, therapy, self-management, in-home, remote, telerehabilitation