NCT02631850

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Traditional CI Therapy	Intensive in-person therapy for upper extremity hemiparesis.
BEHAVIORAL	Gaming CI Therapy	Intensive remote (via video game) therapy for upper extremity hemiparesis.
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.
BEHAVIORAL	Traditional Occupational Therapy/Physical Therapy	Traditional in-person therapy focusing on the rehabilitation of the upper extremity.

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-09-01
• Completion: 2019-12-31
• First posted: 2015-12-16
• Last updated: 2021-10-05
• Results posted: 2021-09-14

Locations

5 sites across 1 country: United States