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Remote Bimanual Virtual Rehabilitation for Elderly With Cerebral Vascular Disease
The aim of the study is to develop the BrightBrainer G (grasp), a game-based upper-extremity motor and cognitive rehabilitation system using custom virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 Exempt medical device produced by Bright Cloud International Corp (FDA owner/operator 10050478), and listed with the FDA (registration number 3012187972);
8 elderly subjects (50 to 80 years old) who live at home and had a stroke more than 9 months prior to participation, who may also suffer from mild cognitive impairments and may be depressed, will be recruited. Their 8 caregivers will also be recruited at Kessler Foundation. Participants will train on the BrightBrainer system for 4 weeks in their home, doing a total of 20 rehabilitation sessions. Sessions will consist of playing therapeutic games using both the impaired and unimpaired arms. Sessions will progress in duration from 20 minutes to 40 minutes of actual play. Before and after the 4 weeks home therapy, participants will travel to the Kessler Foundation (West Orange, NJ) and undergo standardized motor, cognitive, and emotive clinical evaluations.
Age
48 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Kessler Foundation
West Orange, New Jersey, United States
Start Date
September 30, 2015
Primary Completion Date
August 31, 2018
Completion Date
September 13, 2018
Last Updated
July 21, 2021
18
ACTUAL participants
Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games
DEVICE
Lead Sponsor
Grigore Burdea
Collaborators
NCT07360600
NCT06793397
Data Source & Attribution
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