Remote Bimanual Virtual Rehabilitation Post CVD

Remote Bimanual Virtual Rehabilitation for Elderly With Cerebral Vascular Disease

The aim of the study is to develop the BrightBrainer G (grasp), a game-based upper-extremity motor and cognitive rehabilitation system using custom virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 Exempt medical device produced by Bright Cloud International Corp (FDA owner/operator 10050478), and listed with the FDA (registration number 3012187972);

Study Overview

• Status: Completed
• Conditions: Depression; Cognitive Impairment; Stroke Sequelae
• Intervention / Treatment: Device: Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games

Detailed Description

8 elderly subjects (50 to 80 years old) who live at home and had a stroke more than 9 months prior to participation, who may also suffer from mild cognitive impairments and may be depressed, will be recruited. Their 8 caregivers will also be recruited at Kessler Foundation.

Participants will train on the BrightBrainer system for 4 weeks in their home, doing a total of 20 rehabilitation sessions. Sessions will consist of playing therapeutic games using both the impaired and unimpaired arms. Sessions will progress in duration from 20 minutes to 40 minutes of actual play. Before and after the 4 weeks home therapy, participants will travel to the Kessler Foundation (West Orange, NJ) and undergo standardized motor, cognitive, and emotive clinical evaluations.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 48 to 80;
• Diagnosis of stroke which occurred more than 9 months prior (i.e. in the chronic phase);
• English speakers;
• UE unilateral motor involvement (FMA score 10 to 45);
• Be able to actively move UE more than 15 degrees for shoulder and for elbow flexion/extension;
• Be more than 4 months post casting procedures or Botulinum toxin injections;
• Have cognitive skills to participate (Montreal Cognitive Assessment score 18-30).
• Potential participants will not be excluded due to co-morbidities such as Parkinson, frozen shoulder, or arthritis;
• Have normal cognition or MCI.

Exclusion Criteria:

• Be younger than 48 or older than 80;
• Present with severe visual neglect or legally blind;
• Have severe hearing loss or deafness;
• Present with receptive aphasia or severe expressive aphasia;
• Have uncontrolled hypertension (>190/100 mmHg);
• Have severe cognitive delay;
• Cannot speak English;
• Have history of violence or drug abuse;
• Participants who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment will be excluded;
• Have severe hand spasticity and/or complete lack of arm movement;
• MoCA scores of 17 and below.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Treatment; Participants will undergo 4 weeks (20 sessions) of experimental rehabilitation in their home. They will play custom therapeutic games that are intensive and adapt to their condition. Before and after the 4-week intervention participants will travel to Kessler Foundation to undergo evaluations. The therapy is designed to improve arm range, strength, endurance, as well as memory, focusing and decision making. Data will be stored on the cloud, protected and monitored by the research team.

Device: Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games; 20 sessions of playing therapeutic games using both arms while siting at a table at home. Arms hold either generic game controllers, or BrightBrainer therapeutic controllers. Sessions involve a variety of games that train motor and cognitive function in an integrative way. The games are rendered by the BrightBrainer system. Games adapt and are winnable, benefiting well-being (reducing depression). Each session may generate many hundreds of arm repetitions, finger movement and grasps, depending on session duration. Data on arm reach as well as game outcomes and vitals are uploaded to an secure server. These data allow researchers to remotely monitor compliance to protocol and longitudinal progress. Caregivers are present at each session, and provide feedback as well as subjective ratings of the system.; Other Names: BrightBrainer using BrightBrainer Grasp therapeutic controller

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment of Upper Extremity Function (Upper Extremity Sub-scale)	Upper Extremity motor function Sub-Scale: 0 (completely impaired) to 66 (normal).	Change from baseline at 4 weeks
Trail Making Test B (TMT-B) (raw score) measure of cognitive executive function	Timed test measures the subject's executive function. Subject is asked to connect dots of a page (with associated digits) in increasing magnitude, in the shortest time. Less time (measured in seconds) is better.	Change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper extremity functional index (UEFI) self-report of independence in daily activities	Self-report of Independence in activities of daily living (ADLs). Scale: 0 (complete lack of independence in performing a given ADLs) to 80 (completely independent in that task). The form reports on 20 ADLs, which the highest score being 4 on each of them. Thus the highest possible score is 80 (20x4).	Change from baseline at 4 weeks
Chedoke Arm and Hand Activity Inventory (CAHAI) 9 measure of independence in bimanual daily activities	ADL independence in bimanual tasks. Score Scale: 0 (completely impaired) to 63 (normal). Higher score is better, represented more independence in performing tasks with both hands.	Change from baseline at 4 weeks
Arm range of motion (degrees) measure for shoulder, elbow, wrist and fingers	Measurement of active movement range for shoulder, elbow and fingers. Subjects' arm range of motion in each kinematic angles are measured in degree using a goniometer. Larger number is better (more range of motion)	Change from baseline at 4 weeks
Shoulder strength for deltoid muscles	Measurement of shoulder strength using calibrated wrist weights. Subjects' shoulder strength is measured in pounds (lbs). More is better. 0 means no strength at all.	Change from baseline at 4 weeks
Grasp strength for power grasps and pinch grasps	Grasp strength and pinch strength measurements using dynamo-meter and pinch meter. Three readings are used for the dynamometer when subject is asked to exert maximum power grasp, and then averaged. More is better. Minimum score is 0 (no strength at all).	Change from baseline at 4 weeks
Neuropsychological Assessment Battery NAB Verbal and Visual Attention Module	Test for Verbal and visual attention will use Attention module digit span (working memory), dots (visual), which measures quantified metrics of subject's attention level. Dot test has a min of 0 (subject does not find the added dot) and a max of 12 (subject finds all added dots)	Change from baseline at 4 weeks
Trail Making Test A (TMT-A) measure of visual and cognitive processing speed	Timed test measures the subject's Processing speed - visual and cognitive processing speed. Less time is better (1 second)	Change from baseline at 4 weeks
Hopkins Verbal Learning Test, Revised (HVLT-R) measure of verbal, visual and memory	Tests measures the subject's verbal, visual and cognitive ability including delayed. Has 3 sub-tests plus a delayed recall test. Each sub-test has a min of 0 and a max of 12. Delayed recall has a min of 0 and a max of 24. More is better	Change from baseline at 4 weeks
Boston Naming Test (short form) test of verbal abbility in name (noun) associations	Test measures subject's verbal and cognitive ability by asking specific questions. Min score 0 (unable to answer any of 15 questions) max score 15 (answers all). More is better	Change from baseline at 4 weeks
Brief Visuospatial Memory Test-Revised (Raw score)	Timed Test of visuo-spatial memory by asking subjects to draw shapes they had seen. Higher score is better. Has alternate forms, only one form will be used in one evaluation.	4 weeks
Beck Depression Inventory II measure of depression severity	Depression severity score (0 min, 63 max, less is better). 0 normal, 1-13 minimal; 14-19 Mild Depression; 20-28 Moderate Depression; 29-63 Severe Depression	Change from baseline at 4 weeks
Subjective evaluation by participant of the experimental therapy	Participant fills a custom questionnaire with 10 questions. Each question uses a 5-Point Likert scale the system ease of use, perceived benefits and technical issues. Scale (0: Strongly disagree, 4: Strongly agree. i.e., in favor of the system). Higher score is better. Maximum score if all are rated at strongly agree is 40.	4 weeks
Blood Pressure measure by medical meter	Blood pressure taken at each session (needs to be within physiological limits). Blood pressure is measured at start, mid and end of session.	4 weeks
Pulse measure by medical meter	Pulse taken at every session. Pulse is measured at start, mid and end of session.	4 weeks
Arm Reach Baseline (computer measure)	Arm reach area (square inches) measured at start of session. Higher value of reach area is better.	4 weeks
Session duration (computer measure)	Duration of exercises performed on the device during a session, measured in minutes by the computer. Minimum is 15 minutes, maximum is 40 minutes More is better.	4 weeks
Average game scores (computer measure)	Average of scores achieved by a subjects when playing therapeutic games in a given session. The higher the average the better. Range is 1 (lowest difficulty) to 10 (highest difficulty).	4 weeks
Arm repetitions (computer measure)	Computer measure of total arm repetitions done by the subject in the process of playing therapeutic games. The higher the number the better. Minimum is 0 meaning the subject had not mover either arm at all during the session.	4 weeks
Finger extension repetitions (computer measure)	Computer measure of total finger extension repetitions done by the subject in the process of playing therapeutic games. The higher the number the better. Minimum is 0 meaning the subject had not opened either hand at all during the session.	4 weeks
Grasping repetitions (computer measure)	Computer measure of total grasp repetitions done by the subject in the process of playing therapeutic games in a given session. When playing bimanually, the grasps by each hand are added in this measure. The higher the number the better. Minimum is 0 meaning the subject had not grasped at all during the session.	4 weeks
Training intensity for arm and finger movements per minute (computer measure)	Computer measure of average number of arm repetitions and of finger movements or grasps done by a participant in 1 minute in the process of playing therapeutic games. The higher the number the better. Minimum is 0 meaning the participant had not played at all (had no repetitions during that session).	4 weeks
Cognitive areas trained (computer measure)	Computer measure of minutes of specific cognitive area training during a session. Specific domains are Attention, Memory, Executive Function and Language. Minimum is 0 (that area was not trained in a session). Maximum is session duration (up to 40 minutes) when only one cognitive area was trained during a session.	4 weeks
Average game level of difficulty (Computer Measure)	Computer measure of average game difficulty of all the games played by the subject in a give session. The higher the number the better. Minimum is 1 meaning the subject had played all the games at the lowest level of difficulty in that session. Maximum is 10 (all games were played at their highest level of difficulty).	4 weeks

Collaborators and Investigators

• Sponsor: Grigore Burdea
• Collaborators: Kessler Foundation
• Investigators: Study Director: AM Barrett, MD, Kessler Foundation

Publications and helpful links

Helpful Links

• site showing device

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2015
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): September 13, 2018

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; virtual reality; gamification; upper extremity; home; BrightBrainer
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Phase I Tele-Rehab; GRANT R43AG052290 (Other Grant/Funding Number: NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will publish group analysis data, or case data, but no individually identifiable data will be released, per Federal Regulations pertaining to Protected Health Information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No