Remote Bimanual Virtual Rehabilitation Post CVD
Condition: Stroke Sequelae; Cognitive Impairment; Depression
MeSH terms: Cognitive Dysfunction
Study type: Interventional

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);
    

Detailed description: 
      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.
    

Intervention name(s): Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): BrightBrainer using BrightBrainer Grasp therapeutic controller
Intervention model: Single Group Assignment
Intervention model description: 20 elderly subjects. Or these 4 healthy age-matched volunteers for usability, and 8 elderly stroke survivors to determine technology acceptance and clinical benefit to motor, cognitive and emotive function, under remote rehabilitation conditions. We will also recruit their 8 caregivers so to have better feedback in changes they observe in the stroke survivors and any technology issues. Among them, one patient dropped, 7 patients (and their caregivers) completed the study. The subjects in this feasibility study will have UE motor impairments, normal cognition or have Mild Cognitive Impairment (MCI).
Pre- and Post-intervention standardized evaluations will be used to determine benefit. Subjective evaluations and adherence to protocol will indicate acceptance of the technology.
Each session of game exercises will store performance data, which will be monitored remotely.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual reality; stroke; upper extremity; BrightBrainer; rehabilitation; home; gamification