Remote Bimanual Virtual Rehabilitation for Elderly With Cerebral Vascular Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment of Upper Extremity Function (Upper Extremity Sub-scale)
Study Overview
Brief Summary
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);
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 48 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games (Device)
Outcomes
Primary Outcomes
Fugl-Meyer Assessment of Upper Extremity Function (Upper Extremity Sub-scale)
Time Frame: Change from baseline at 4 weeks
Upper Extremity motor function Sub-Scale: 0 (completely impaired) to 66 (normal).
Trail Making Test B (TMT-B) (raw score) measure of cognitive executive function
Time Frame: Change from baseline at 4 weeks
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.
Secondary Outcomes
- Shoulder strength for deltoid muscles(Change from baseline at 4 weeks)
- Trail Making Test A (TMT-A) measure of visual and cognitive processing speed(Change from baseline at 4 weeks)
- Upper extremity functional index (UEFI) self-report of independence in daily activities(Change from baseline at 4 weeks)
- Arm range of motion (degrees) measure for shoulder, elbow, wrist and fingers(Change from baseline at 4 weeks)
- Neuropsychological Assessment Battery NAB Verbal and Visual Attention Module(Change from baseline at 4 weeks)
- Brief Visuospatial Memory Test-Revised (Raw score)(4 weeks)
- Subjective evaluation by participant of the experimental therapy(4 weeks)
- Grasp strength for power grasps and pinch grasps(Change from baseline at 4 weeks)
- Boston Naming Test (short form) test of verbal abbility in name (noun) associations(Change from baseline at 4 weeks)
- Blood Pressure measure by medical meter(4 weeks)
- Arm Reach Baseline (computer measure)(4 weeks)
- Session duration (computer measure)(4 weeks)
- Arm repetitions (computer measure)(4 weeks)
- Average game level of difficulty (Computer Measure)(4 weeks)
- Chedoke Arm and Hand Activity Inventory (CAHAI) 9 measure of independence in bimanual daily activities(Change from baseline at 4 weeks)
- Beck Depression Inventory II measure of depression severity(Change from baseline at 4 weeks)
- Average game scores (computer measure)(4 weeks)
- Training intensity for arm and finger movements per minute (computer measure)(4 weeks)
- Hopkins Verbal Learning Test, Revised (HVLT-R) measure of verbal, visual and memory(Change from baseline at 4 weeks)
- Finger extension repetitions (computer measure)(4 weeks)
- Grasping repetitions (computer measure)(4 weeks)
- Pulse measure by medical meter(4 weeks)
- Cognitive areas trained (computer measure)(4 weeks)
Investigators
Grigore Burdea
Chief Technology Officer
Bright Cloud International Corp