Clinical trial NCT02631850: Effectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity Rehabilitation
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: OhioHealth
name: Providence Medical Research Center
name: University of Alabama at Birmingham
name: University of Massachusetts, Lowell
name: University of Missouri-Columbia
First posted: 2015-12-16
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Wolf Motor Function Test
timeFrame: 0 to 1 months
measure: Motor Activity Log Quality of Movement Scale
timeFrame: 0 to 1 months
Secondary outcomes:
measure: Change in Neuro-Quality of Life (Neuro-QOL)
timeFrame: 0 to 1 months
measure: Bilateral Activity Monitors
timeFrame: 0 to 1 month
measure: Change in Brief Kinesthesia Test (BKT)
timeFrame: 0 to 1 months
measure: Semmes-Weinstein Monofilament Test
timeFrame: 0 to 1 months
measure: 9 Hole Peg Test
timeFrame: 0 to 1 months
Other outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: baseline only measure, exploratory covariate in the analysis
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University, 2154 Dodd Hall
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Rehabilitation
state: Ohio
city: Medford
country: United States
facility: Providence Medford Medical Center
state: Oregon
Study officials:
affiliation: The Ohio State U.
name: Deborah Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.