NCT04252170

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Feasibility Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (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 feasibility of the BrightArm Compact robotic rehabilitation system for patients early sub-acute post Cerebral Vascular Accident. The aims are to: a) determine clinical benefit to motor and cognitive function as well as mood; 2) to ascertain technology acceptance by patients and therapists. The experimental training consists of 12 integrative arm/hand and cognitive training by playing therapeutic games. Participants are evaluated pre-and post-intervention and provide subjective evaluation of the system.

Detailed description

This study targets participants, who had suffered a first stroke recently, and 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) bilateral rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities. Specific aims are: * BAC technology acceptance; * improvement in motor function for the upper extremity; * strengthening of shoulder and fingers; * increased active (self initiated) range of motion for shoulder, arms and fingers; * improved independence in activities of daily living; * improvement in cognitive areas of memory, attention and decision making; * improved mood (as in reduced depression severity);

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Rehabilitation Therapy, Experimental on the BrightArm Compact device	Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). An Occupational Therapist will assist as needed.

Timeline

• Start date: 2018-09-15
• Primary completion: 2018-12-31
• Completion: 2019-01-31
• First posted: 2020-02-05
• Last updated: 2020-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study