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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02631850
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : December 21, 2018
Sponsor:
Collaborators:
OhioHealth
Providence Medical Research Center
University of Alabama at Birmingham
Information provided by (Responsible Party):
Deborah S Larsen, Ohio State University

Brief 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, 4 therapist contact hours via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard occupational therapy. 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).

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

Detailed Description:
Detailed study description in press with BMC Neurology (2017).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: 0 to 1 months ]
    assessment to evaluate motor function

  2. Motor Activity Log [ Time Frame: 0 to 1 months ]
    assessment to evaluate carry-over into daily life


Secondary Outcome Measures :
  1. Neuro-QOL [ Time Frame: 0 to 1 months ]
    assessment to measure quality of life

  2. Bilateral Activity Monitors [ Time Frame: 0 to 1 month ]
    devices to monitor upper extremity movement throughout treatment

  3. Brief Kinesthesia Test [ Time Frame: 0 to 1 months ]
    assessment to measure kinesthesia

  4. Touch Test Monofilaments [ Time Frame: 0 to 1 months ]
    sensory evaluator

  5. 9 hole peg test [ Time Frame: 0 to 1 months ]
    assessment to measure upper extremity motor function

  6. Montreal Cognitive Assessment [ Time Frame: baseline only ]
    assessment to measure cognitive function



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Information from the National Library of Medicine

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


Contacts
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Contact: Deborah V Larsen, PhD 614-292-5645 deborah.larsen@osumc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Gitendra Uswatte       guswatte@uab.edu   
United States, Ohio
The Ohio State University, 2154 Dodd Hall Recruiting
Columbus, Ohio, United States, 43210
Contact: Deborah Larsen, PhD    614-292-5645    Deborah.larsen@osumc.edu   
Principal Investigator: Deborah Larsen, PhD         
OhioHealth Rehabilitation Recruiting
Columbus, Ohio, United States, 43220
Contact: Marie Simeo, DPT       marie.simeo@ohiohealth.com   
United States, Oregon
Providence Medford Medical Center Recruiting
Medford, Oregon, United States, 97504
Contact: Nancy Strahl       nancy.strahl@gmail.com   
Sponsors and Collaborators
Ohio State University
OhioHealth
Providence Medical Research Center
University of Alabama at Birmingham
Investigators
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Principal Investigator: Deborah Larsen, PhD The Ohio State U.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Deborah S Larsen, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02631850    
Other Study ID Numbers: 2012H0151
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made public 1 year after study completion.
Keywords provided by Deborah S Larsen, Ohio State University:
Constraint-induced movement therapy
gaming
virtual reality
upper extremity
CI therapy
rehabilitation
stroke
hemiparesis
therapy
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms