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

Status:	Recruiting
Conditions:	Neurology, Neurology
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	18 - Any
Updated:	12/23/2018
Start Date:	November 2015
End Date:	April 2020
Contact:	Deborah V Larsen, PhD
Email:	deborah.larsen@osumc.edu
Phone:	614-292-5645

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.

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).

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

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

We found this trial at

sites

The Ohio State University, 2154 Dodd Hall

Columbus, Ohio 43210

Principal Investigator: Deborah Larsen, PhD

Phone: 614-292-5645

from

Columbus, OH