Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

Bright Cloud International

Status

Completed

Conditions

Stroke

Treatments

Device: Rehabilitation Therapy, Experimental on the BrightArm Compact device

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT04252170

5R44AG044639-05 (U.S. NIH Grant/Contract)

BCI-10-001

Details and patient eligibility

About

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.

Full 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);

Enrollment

2 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 50 to 85;
diagnosis of first-time CVA that occurred more than 5 days prior and less than 21 days prior
English speakers;
UE unilateral or bilateral involvement (from new bilateral CVA)
motor involvement (FMA score 20 to 45);
ability to actively move UE more than 10 degrees for shoulder and elbow flexion/extension;
ability to actively extend fingers at least 5 degrees
cognitive skills to participate (Montreal Cognitive Assessment (MoCA) [Nasreddine et al 2005] score 10-30).
Subjects may have normal cognition, MCI or dementia

Exclusion criteria

being younger than 50 or older than 85 years of age
previous stroke
Stroke that occurred more than 20 days prior to enrollment
Inability to actively extend fingers at least 5 degrees;
Fugl-Meyer scores of 19 or less;
severe visual neglect or legally blind
severe hearing loss or deafness
receptive aphasia or severe expressive aphasia;
severe spasticity (Modified Ashworth Scale 4/4)
contractures of the upper limb joints
uncontrolled hypertension (>190/100 mmHg)
severe cognitive impairment determined by Montreal Cognitive Assessment (MoCA) [Nasreddine et al, 2005] test of 9 and below;
No chemodenervation or nerve block to upper limb involved during the experimental period (e.g., botulinum toxin injection)
inability to speak English;
a history of violence or drug abuse;
paranoia and psychotic behavior;
inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders).