N/A
N=168
Effectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity Rehabilitation
Stroke · Hemiparesis
Bottom Line
View on ClinicalTrials.gov: NCT02631850 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Wolf Motor Function Test — -0.38; -0.24; -0.29; -0.22 natural log of performance time change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Traditional CI Therapy (Behavioral); Gaming CI Therapy (Behavioral); Gaming CI Therapy with Additional Contact via Video Conference (Behavioral); Traditional Occupational Therapy/Physical Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wolf Motor Function Test |
-0.38; -0.24; -0.29; -0.22 | — |
| PRIMARY Motor Activity Log Quality of Movement Scale |
1.7; 1.3; 1.5; .5 | — |
| SECONDARY Change in Neuro-Quality of Life (Neuro-QOL) |
.69; -.05; -.72; .82 | — |
| SECONDARY Bilateral Activity Monitors |
.12; 0; .05; .04 | — |
| SECONDARY Change in Brief Kinesthesia Test (BKT) |
-1.8; -.9; .8; -1.0 | — |
| SECONDARY Semmes-Weinstein Monofilament Test |
-.25; -.39; -.03; -.50 | — |
| SECONDARY 9 Hole Peg Test |
-.08; -.53; .49; .94 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02631850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.