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

NCT ID: NCT04724954

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rehabilitation Therapy on Experimental Robotic Table and standard of care

10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited for experimental group.

The investigators will also recruit the 10 caregivers of the experimental subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states.

Group Type: EXPERIMENTAL

Rehabilitation Therapy on Experimental Robotic Table and standard of care

Intervention Type: DEVICE

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

Rehabilitation Therapy as part of Standard of Care

10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited as a control group.

The investigators will also recruit the 10 caregivers of the control subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states.

Group Type: SHAM_COMPARATOR

Rehabilitation Therapy as part of Standard of Care (Control)

Intervention Type: GENETIC

Control group will receive Standard of Care training only

Interventions

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

Intervention Type: DEVICE

Rehabilitation Therapy as part of Standard of Care (Control)

Control group will receive Standard of Care training only

Intervention Type: GENETIC

Other Intervention Names

BrightArm Compact Rehabilitation

Eligibility Criteria

Inclusion Criteria

• Age 50 to 85;
• Healthy age-matched volunteers
• diagnosis of CVA that occurred more than 5 days prior and less than 21 days prior (for the stroke survivors group);
• 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 10o for shoulder and elbow flexion/extension;
• ability to actively extend fingers at least 5o
• cognitive skills to participate (Montreal Cognitive Assessment (MoCA) [Nasreddine et al 2005] score 10-30).
• The adaptive nature of BBC system hardware and therapeutic games can compensate for the motor limitations due to other co-morbidities. Therefore potential participants will not be excluded due to co-morbidities such as Parkinson or arthritis.

Subjects may have normal cognition, MCI or dementia, since the games can compensate for diminished cognition through built-in cues and instructions.

• Inclusion Criterion for the controlled clinical trials arm at Kessler Foundation

• Living within 25 miles radius of Kessler Foundation West Orange location. This will facilitate participation in the outpatient clinic training, which follows inpatient rehabilitation.

Exclusion Criteria

• being younger than 50 or older than 85 years of age
• previous stroke
• Stroke that occurred more than 20 days prior to enrolment
• Inability to actively extend fingers at least 5 degrees; v. 7/8/2018
• 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 behaviour.
• inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders).

o Those living outside approximately 25 miles radius of Kessler Foundation West Orange location. Those living too far will have a harder time completing the study as outpatients, as they will probably choose clinics closer to home.

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

Sponsors

Kessler Foundation

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Bright Cloud International Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Grigore Burdea

Chief Technology Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grigore C Burdea, PhD

Role: STUDY_DIRECTOR

Bright Cloud International Corp

Locations

Bright Cloud Int'l Corp

North Brunswick, New Jersey, United States

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Related Links

http://www.BrightBrainer.com

BCI's corporate site showing therapeutic games used with the device

Other Identifiers

R44AG044639

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Phase IIB Clinical Trial

Identifier Type: -

Identifier Source: org_study_id