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

NCT ID: NCT02631850

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-12-31

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, 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

Detailed study description published in BMC Neurology (2017).

Conditions

Stroke; Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Traditional CI Therapy

Intervention Type: BEHAVIORAL

Intensive in-person therapy for upper extremity hemiparesis.

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.

Group Type: ACTIVE_COMPARATOR

Gaming CI Therapy

Intervention Type: BEHAVIORAL

Intensive remote (via video game) therapy for upper extremity hemiparesis.

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 2.6 hours video conference consultation throughout the treatment period.

Group Type: ACTIVE_COMPARATOR

Gaming CI Therapy with Additional Contact via Video Conference

Intervention Type: BEHAVIORAL

Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.

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 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.

Group Type: ACTIVE_COMPARATOR

Traditional Occupational Therapy/Physical Therapy

Intervention Type: BEHAVIORAL

Traditional in-person therapy focusing on the rehabilitation of the upper extremity.

Interventions

Traditional CI Therapy

Intensive in-person therapy for upper extremity hemiparesis.

Intervention Type: BEHAVIORAL

Gaming CI Therapy

Intensive remote (via video game) therapy for upper extremity hemiparesis.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Traditional Occupational Therapy/Physical Therapy

Traditional in-person therapy focusing on the rehabilitation of the upper extremity.

Intervention Type: BEHAVIORAL

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OhioHealth

OTHER

Sponsor Role: collaborator

Providence Medical Research Center

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of Massachusetts, Lowell

OTHER

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Deborah S Larsen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Larsen, PhD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State U.

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Missouri

Columbia, Missouri, United States

The Ohio State University, 2154 Dodd Hall

Columbus, Ohio, United States

OhioHealth Rehabilitation

Columbus, Ohio, United States

Providence Medford Medical Center

Medford, Oregon, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28595611 (View on PubMed)

Gauthier LV, Ravi R, DeLuca D, Zhou W. Dose Response to Upper Extremity Stroke Rehabilitation Varies by Individual: Early Indicators of Treatment Response. Stroke. 2024 Mar;55(3):696-704. doi: 10.1161/STROKEAHA.123.045039. Epub 2024 Feb 26.

Reference Type: DERIVED

PMID: 38406850 (View on PubMed)

Borstad A, Nichols-Larsen D, Uswatte G, Strahl N, Simeo M, Proffitt R, Gauthier L. Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Aug;36(8):525-534. doi: 10.1177/15459683221107893. Epub 2022 Jun 11.

Reference Type: DERIVED

PMID: 35695197 (View on PubMed)

Gauthier LV, Nichols-Larsen DS, Uswatte G, Strahl N, Simeo M, Proffitt R, Kelly K, Crawfis R, Taub E, Morris D, Lowes LP, Mark V, Borstad A. Video game rehabilitation for outpatient stroke (VIGoROUS): A multi-site randomized controlled trial of in-home, self-managed, upper-extremity therapy. EClinicalMedicine. 2021 Dec 17;43:101239. doi: 10.1016/j.eclinm.2021.101239. eCollection 2022 Jan.

Reference Type: DERIVED

PMID: 34977516 (View on PubMed)

Rafiei MH, Kelly KM, Borstad AL, Adeli H, Gauthier LV. Predicting Improved Daily Use of the More Affected Arm Poststroke Following Constraint-Induced Movement Therapy. Phys Ther. 2019 Dec 16;99(12):1667-1678. doi: 10.1093/ptj/pzz121.

Reference Type: DERIVED

PMID: 31504952 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2012H0151

Identifier Type: -

Identifier Source: org_study_id