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

Stroke Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631850
• Other study ID #: 2012H0151
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

Detailed study description published in BMC Neurology (2017).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: December 31, 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Behavioral:
• Traditional CI Therapy
Intensive in-person therapy for upper extremity hemiparesis.
• Gaming CI Therapy
Intensive remote (via video game) therapy for upper extremity hemiparesis.
• Gaming CI Therapy with Additional Contact via Video Conference
Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
• Traditional Occupational Therapy/Physical Therapy
Traditional in-person therapy focusing on the rehabilitation of the upper extremity.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Missouri	Columbia	Missouri
United States	OhioHealth Rehabilitation	Columbus	Ohio
United States	The Ohio State University, 2154 Dodd Hall	Columbus	Ohio
United States	Providence Medford Medical Center	Medford	Oregon

Sponsors (6)

Lead Sponsor	Collaborator
Ohio State University	OhioHealth, Providence Medical Research Center, University of Alabama at Birmingham, University of Massachusetts, Lowell, University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gauthier LV, Kane C, Borstad A, Strahl N, Uswatte G, Taub E, Morris D, Hall A, Arakelian M, Mark V. Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis. BMC Neurol. 2017 Jun 8;17(1):109. doi: 10.1186/s12883-017-0888-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Montreal Cognitive Assessment (MoCA)	Assessment to measure cognitive function at baseline. The range of the MoCA assessment is 0-30. Scores below 24 indicate cognitive impairment and scores below 16 indicate severe cognitive impairment. The MoCA was administered for the purpose of characterizing the study population and was examined as a potential covariate in linear mixed effect models examining primary and secondary outcome measures.	baseline only measure, exploratory covariate in the analysis
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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