Effectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity Rehabilitation
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|ClinicalTrials.gov Identifier: NCT02631850|
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiparesis||Behavioral: Traditional CI Therapy Behavioral: Gaming CI Therapy Behavioral: Gaming CI Therapy with Additional Contact via Video Conference Behavioral: Traditional Occupational Therapy/Physical Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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.|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2020|
Active Comparator: Traditional CI Therapy
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
Intensive in-person therapy for upper extremity hemiparesis.
Active Comparator: Gaming CI Therapy
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
Intensive remote (via video game) therapy for upper extremity hemiparesis.
Active Comparator: Gaming CI Therapy with Additional Contact via Video Conference
This group will receive treatment that is identical to Group 2, but will receive an additional 4 hours video conference consultation throughout the treatment period.
Behavioral: 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.
Active Comparator: Traditional Occupational Therapy/Physical Therapy
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 ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of stretching 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
Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
- Wolf Motor Function Test [ Time Frame: 0 to 1 months ]assessment to evaluate motor function
- Motor Activity Log [ Time Frame: 0 to 1 months ]assessment to evaluate carry-over into daily life
- Neuro-QOL [ Time Frame: 0 to 1 months ]assessment to measure quality of life
- Bilateral Activity Monitors [ Time Frame: 0 to 1 month ]devices to monitor upper extremity movement throughout treatment
- Brief Kinesthesia Test [ Time Frame: 0 to 1 months ]assessment to measure kinesthesia
- Touch Test Monofilaments [ Time Frame: 0 to 1 months ]sensory evaluator
- 9 hole peg test [ Time Frame: 0 to 1 months ]assessment to measure upper extremity motor function
- Montreal Cognitive Assessment [ Time Frame: baseline only ]assessment to measure cognitive function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631850
|Contact: Deborah V Larsen, PhDfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Gitendra Uswatte email@example.com|
|United States, Ohio|
|The Ohio State University, 2154 Dodd Hall||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Deborah Larsen, PhD 614-292-5645 Deborah.firstname.lastname@example.org|
|Principal Investigator: Deborah Larsen, PhD|
|Columbus, Ohio, United States, 43220|
|Contact: Marie Simeo, DPT email@example.com|
|United States, Oregon|
|Providence Medford Medical Center||Recruiting|
|Medford, Oregon, United States, 97504|
|Contact: Nancy Strahl firstname.lastname@example.org|
|Principal Investigator:||Deborah Larsen, PhD||The Ohio State U.|