Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Clinical Trial)
Condition: Acute Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The research project is intended to provide information pertaining to the usability,
      feasibility and clinical benefit of the BAC system for early sub-acute post CVA
      rehabilitation, improved cognition and emotive state while in acute inpatient rehabilitation
      settings (Kessler Foundation) and in an outpatient clinic at the same research hospital.

      The randomised controlled trials will take place at Kessler Foundation (West Orange, NJ). It
      will develop a new longitudinal therapy for elderly stroke survivors who are inpatients and
      then outpatients at a regional rehabilitation hospital, by adding BAC training to customary
      care for both inpatients and outpatients. Two systems will be used, improving continuity of
      care (one each for inpatient and outpatient settings).
    

Detailed description: 
      This study targets participants, who had suffered a stroke very recently, who may or may not
      have been diagnosed with mild cognitive impairments or dementia (including Alzheimer's
      disease). It is important to find out if these improvements can be obtained with the computer
      game-based integrative (motor-cognitive) bimanual rehabilitation developed by Bright Cloud
      International Corp, and if these gains transfer to daily activities. The study also aims at
      determining benefit of continuum care training on the BAC in addition to conventional
      rehabilitation for participants who are inpatients and then outpatients at a rehabilitation
      hospital and clinic.

      Specific aims are:

      BAC technology acceptance (all groups); improved motor function for upper extremity;
      strengthening shoulder and fingers increased range of motion for arms and fingers; improved
      independence in activities of daily living; improved cognition; improved emotive state;
      reduction in perceived upper body pain.

      Another component of the research project is a small pilot targeting individuals with
      Parkinson's disease. For them the project is going to:

      determine technology acceptance when using the BrightBrainer system; benefit to arms motor
      function and strengthening when playing BCI therapeutic games; benefit to reduction or tremor
      when playing games; cognitive benefits improvement in their well-being.
    

Intervention name(s): Rehabilitation Therapy on Experimental Robotic Table and standard of care; Rehabilitation Therapy as part of Standard of Care (Control)
Intervention type(s): Device; Genetic
Intervention description(s): Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). They will also receive Standard of Care rehabilitation; Control group will receive Standard of Care training only
Other intervention name(s): BrightArm Compact Rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Number of subjects: The Investigators expect to enroll up to 40 subjects, inpatients and then outpatients at a research hospital and its outpatient clinic at Kessler Foundation: 20 stroke patients, and 20 will be their spouses/caregivers of subjects participating in the randomized control trials component of this study.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: acute stroke; sub-acute stage