NCT04724954

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Clinical Trial)

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Bright Cloud International Corp · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Stroke

Interventions

Type	Name	Description
DEVICE	Rehabilitation Therapy on Experimental Robotic Table and standard of care	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
GENETIC	Rehabilitation Therapy as part of Standard of Care (Control)	Control group will receive Standard of Care training only

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-06-15
• Completion: 2019-12-31
• First posted: 2021-01-26
• Last updated: 2021-07-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study