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

NCT02631850 | Completed Results

• 1 other identifier: 2012H0151
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 5

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).

Conditions

Stroke; Hemiparesis

Keywords

Constraint-induced movement therapy; gaming; virtual reality; upper extremity; CI therapy; rehabilitation; stroke; hemiparesis; therapy; self-management; in-home; remote; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in Neuro-Quality of Life (Neuro-QOL)

  0 to 1 months

• Bilateral Activity Monitors

  0 to 1 month

• Change in Brief Kinesthesia Test (BKT)

  0 to 1 months

• Semmes-Weinstein Monofilament Test

  0 to 1 months

• 9 Hole Peg Test

  0 to 1 months

Other Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  baseline only measure, exploratory covariate in the analysis

Study Arms (4)

Traditional CI Therapy

ACTIVE COMPARATOR

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

Gaming CI Therapy

ACTIVE COMPARATOR

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

Gaming CI Therapy with Additional Contact via Video Conference

ACTIVE COMPARATOR

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

Traditional Occupational Therapy/Physical Therapy

ACTIVE COMPARATOR

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

Interventions

Traditional CI Therapy BEHAVIORAL

Intensive in-person therapy for upper extremity hemiparesis.

Traditional CI Therapy

Gaming CI Therapy BEHAVIORAL

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

Gaming CI Therapy

Gaming CI Therapy with Additional Contact via Video Conference BEHAVIORAL

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

Gaming CI Therapy with Additional Contact via Video Conference

Traditional Occupational Therapy/Physical Therapy BEHAVIORAL

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

Traditional Occupational Therapy/Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• OhioHealth: collaborator
• Providence Medical Research Center: collaborator
• University of Alabama at Birmingham: collaborator
• University of Massachusetts, Lowell: collaborator
• University of Missouri-Columbia: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Missouri

Columbia, Missouri, United States

Location

The Ohio State University, 2154 Dodd Hall

Columbus, Ohio, 43210, United States

Location

OhioHealth Rehabilitation

Columbus, Ohio, 43220, United States

Location

Providence Medford Medical Center

Medford, Oregon, 97504, United States

Location

Related Publications (5)

• 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.

  PMID: 28595611 BACKGROUND

• 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.

  PMID: 38406850 DERIVED

• 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.

  PMID: 35695197 DERIVED

• 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.

  PMID: 34977516 DERIVED

• 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.

  PMID: 31504952 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Results Point of Contact

• Title: Lynne Gauthier
• Organization: University of Massachusetts Lowell

lynne_gauthier@uml.edu

9789345383

Study Officials

• Deborah Larsen, PhD

  The Ohio State U.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 31, 2019
• Last Updated: October 5, 2021
• Results First Posted: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon publication of the main results paper.
• Access Criteria: Will update with public URL upon acceptance of the study paper. Prior to this, those interesting in accessing the study data can contact lynne\ gauthier@uml.edu to arrange access.

Locations

US (5)