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Remote Bimanual Virtual Rehabilitation Post CVD

NCT04713384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-07-21

No results posted yet for this study

Summary

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);

Conditions

Interventions

DEVICE

Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games

20 sessions of playing therapeutic games using both arms while siting at a table at home. Arms hold either generic game controllers, or BrightBrainer therapeutic controllers. Sessions involve a variety of games that train motor and cognitive function in an integrative way. The games are rendered by the BrightBrainer system. Games adapt and are winnable, benefiting well-being (reducing depression). Each session may generate many hundreds of arm repetitions, finger movement and grasps, depending on session duration. Data on arm reach as well as game outcomes and vitals are uploaded to an secure server. These data allow researchers to remotely monitor compliance to protocol and longitudinal progress. Caregivers are present at each session, and provide feedback as well as subjective ratings of the system.

Sponsors & Collaborators

  • Kessler Foundation

    collaborator OTHER

  • Grigore Burdea

    lead INDUSTRY

Principal Investigators

  • AM Barrett, MD · Kessler Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
48 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-08-31
Completion
2018-09-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04713384 on ClinicalTrials.gov