CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 193 enrolled
Drug / intervention
Traditional CI Therapy +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02631850
NCT02631850N/ACompleted

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.

Ohio State University·interventional·Posted Dec 16, 2015·Updated Oct 5, 2021

In Brief

A clinical study evaluating Traditional CI Therapy, Gaming CI Therapy, and 2 other interventions for Stroke and Hemiparesis. Completed, enrolled 193 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Hemiparesis
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 16, 2015
Enrollment StartNov 1, 2015
Primary CompletionSep 1, 2019
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.5 years ago

Interventions

Traditional CI Therapybehavioral

Intensive in-person therapy for upper extremity hemiparesis.

Gaming CI Therapybehavioral

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

Gaming CI Therapy with Additional Contact via Video Conferencebehavioral

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

Traditional Occupational Therapy/Physical Therapybehavioral

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