Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Rehabilitation Therapy, Experimental on the BrightArm Compact device

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);

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • PowerBack Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feasibility study, Stroke Survivors; BAC feasibility study at PowerBack, Piscataway NJ, with stroke patients.	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.; Other Names: BrightArm Compact rehabilitation through games

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Artificial Intelligence-determined game difficulty level	BrightBrainer game difficulty setting is determined based on patient's past performance, in order to adapt the therapy to a given individual. It representing an average or difficulties of all games played in a session. The measure implies game play intensity and level of challenge	Through study completion, an average of 3 weeks
Game Score (baseline and performance)	BrightBrainer game baseline and performance scores. Min. score is 0. Max depends on specific game.	Through study completion, an average of 3 weeks
Participants' feedback using 5-point Likert scale	Subjective evaluation feedback and overall ratings on BrightBrainer games. Consists of multiple questions, each ranked on a 5-point Likert scale, with 1 (min) and 5 (max).	Through study completion, an average of 3 weeks
Therapist subjective evaluation using 5-point Likert scale	Subjective evaluation given by the attending Occupational Therapist at the end of the experimental intervention. Multiple questions, each ranked from 1 (min) to 5 (max)	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm Range of Motion	measurement of active movement initiated by participant using a mechanical goniometer	Change from Baseline arm range of motion at 3 weeks
Finger Range of Motion	finger extension/flexion range using a mechanical goniomter	Change from Baseline finger range of motion at 3 weeks
Grasp Strength with Jamar Dynamo-meter	grasp strength measurement using dynamo-meter	Change from Baseline grasp strength at 3 weeks
Pinch strength with pinch meter	Pinch strength measured with fingers placed on a pinch meter	Change from Baseline at 3 weeks
Shoulder strength	Measurement of shoulder strength using calibrated wrist weights	Change from Baseline shoulder strength at 3 weeks
Fugl-Meyer Assessment (Upper Extremity sub-scale) score	Upper Extremity Motor function, score scale is 0 (min) to 66 (max). Larger score means better outcome.	Change from Baseline Fugl-Meyer Assessment Score at 3 weeks
Upper extremity functional index (UEFI) score	A self report of independence in 20 activities of daily living (ADLs). Total score range is 0 (min) to 80 (max). Larger score means better outcome.	Change from Baseline Upper Extremity Functional Inex score at 3 weeks
CAHAI 9 Score	Chedoke Arm and Hand Activity Inventory, reflecting ADL independence in simulated bimanual activities. Min score 9, max score 63, with larger score meaning better outcomes.	Change from Baseline CAHAI 9 score at 3 weeks
Jebsen Test of Hand Function	Timed test of 7 simulated activities of daily living. Lowest score is 0, largest score is 1260. Units are seconds. Lower score means better outcomes (faster completion).	Change from Baseline Jebsen Test of Hand Function score at 3 weeks
Beck Depression Inventory II (BDI II) score	participants' depression measure. Range is 0 (min) to 63 (max). Lower score indicate better outcomes (less depression).	Change from Baseline depression severity at 3 weeks
Verbal attention	Attention module digit span (working memory) in the Neuropsychological Assessment Battery NAB min 0, larger score is better	Change from Baseline verbal attention at 3 weeks
Verbal fluency	verbal fluency test min 0, larger score is better	Change from Baseline verbal fluency at 3 weeks
Verbal memory	Hopkins Verbal Learning Test, Revised (HVLT-R) min 0, larger is better	Change from Baseline verbal learning memory at 3 weeks
Brief Visuospatial Memory Test-Revised	A measure of memory function min 50 std of 10, larger score is better	Change from Baseline visuospatial memory at 3 weeks
Executive Function Module	Word Generation min 0, larger is better	Change from Baseline executive function at 3 weeks
Cognitive executive function	Trail Making Test B (TMT-B) lMin 50, std of 10, larger number means better outcomes	Change from Baseline Trail Making Test B (TMT-B) Score at 3 weeks
Cognitive executive function	NAB Executive Functioning Module min 50, std is 10, larger number means better outcomes	Change from Baseline NAB Exec Score at 3 weeks
Visual attention	Attention module dots (visual) in the Neuropsychological Assessment Battery NAB	Change from Baseline visual attention at 3 weeks

Collaborators and Investigators

• Sponsor: Bright Cloud International Corp
• Collaborators: National Institute on Aging (NIA); Genesis HealthCare System
• Investigators: Study Chair: Grigore C Burdea, Ph.D., BRIGHT CLOUD INTL CORP

Publications and helpful links

General Publications

• 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.

Helpful Links

• BCI's corporate site

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BCI-10-001; 5R44AG044639-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes