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Clinical Trial Summary

This study will determine the feasibility of using an interactive computer game to elicit repetitive practice of paretic arm movements in the homes of community dwelling stroke survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital.


Clinical Trial Description

More than 75% of the 800,000 people who annually suffer stroke exhibit persistent arm/hand hemiparesis restricting independence thus burdening caregivers. Arm motor skill can recover if the rehabilitation program provides an adequate "dose" of repetitive movement practice. However, the vast majority of stroke survivors lack the proper practice-dose because the duration of inpatient stroke rehabilitation is limited by cost, or residence in medically underserved rural settings. To meet the pressing need for innovative cost-effective rehabilitation options, the investigators developed, tested and licensed a prototype virtual environment (VE) for post-stroke arm rehabilitation. Its custom built design motivates extended practice of specific arm motor skills known to improve quality of life. Excitingly, practice sessions do not require direct therapist supervision. Published pilot data demonstrated improved real-world arm movement after VE training. These promising initial results led to software upgrades that will now enable installation and testing in the primary markets for this technology; stroke rehabilitation hospitals, and patients' homes. The overall goal for this small pilot study is to test the feasibility of self-directed VE practice in these settings measured by movement repetitions and motor skill improvement. To that end, this project will address the following Specific Aims (1) Determine the number of daily movement repetitions and treatment effect achieved by inpatients in a stroke rehabilitation hospital who self-direct VE practice sessions during non-therapy hours (evenings, weekends) compared to standard evening activities; and (2) Determine the number of daily movement repetitions and treatment effect achieved by in-home stroke survivors who self-direct daily VE practice sessions compared to a group of in-home survivors with a standard self-directed exercise program. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02882997
Study type Interventional
Source Medical University of South Carolina
Contact
Status Completed
Phase Phase 1/Phase 2
Start date November 2013
Completion date August 2016

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