Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

NCT ID: NCT04252170

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2019-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Feasibility study, Stroke Survivors

BAC feasibility study at PowerBack, Piscataway NJ, with stroke patients.

Group Type: EXPERIMENTAL

Rehabilitation Therapy, Experimental on the BrightArm Compact device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

BrightArm Compact rehabilitation through games

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Genesis HealthCare System

OTHER

Sponsor Role: collaborator

Bright Cloud International Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Nam H. Kim

Director of Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grigore C Burdea, Ph.D.

Role: STUDY_CHAIR

BRIGHT CLOUD INTL CORP

Locations

PowerBack Rehabilitation

Piscataway, New Jersey, United States

Countries

United States

References

Burdea G, Kim N, Polistico K, Kadaru A, Grampurohit N, Hundal J, Pollack S. Robotic Table and Serious Games for Integrative Rehabilitation in the Early Poststroke Phase: Two Case Reports. JMIR Rehabil Assist Technol. 2022 Apr 13;9(2):e26990. doi: 10.2196/26990.

Reference Type: DERIVED

PMID: 35416787 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Related Links

http://www.BrightBrainer.com

BCI's corporate site

Other Identifiers

5R44AG044639-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BCI-10-001

Identifier Type: -

Identifier Source: org_study_id