Clinical trial NCT04713384: Remote Bimanual Virtual Rehabilitation Post CVD
Official title: Remote Bimanual Virtual Rehabilitation for Elderly With Cerebral Vascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Cognitive Impairment
Depression
Keywords: virtual reality
stroke
upper extremity
BrightBrainer
rehabilitation
home
gamification
Lead sponsor: Bright Cloud International Corp
Sponsor class: INDUSTRY
Collaborators: name: Kessler Foundation
First posted: 2021-01-19
Enrollment: 18
Sex: ALL
Minimum age (years): 48
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 20 elderly subjects. Or these 4 healthy age-matched volunteers for usability, and 8 elderly stroke survivors to determine technology acceptance and clinical benefit to motor, cognitive and emotive function, under remote rehabilitation conditions. We will also recruit their 8 caregivers so to have better feedback in changes they observe in the stroke survivors and any technology issues. Among them, one patient dropped, 7 patients (and their caregivers) completed the study. The subjects in this feasibility study will have UE motor impairments, normal cognition or have Mild Cognitive Impairment (MCI).

Pre- and Post-intervention standardized evaluations will be used to determine benefit. Subjective evaluations and adherence to protocol will indicate acceptance of the technology.

Each session of game exercises will store performance data, which will be monitored remotely.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity Function (Upper Extremity Sub-scale)
timeFrame: Change from baseline at 4 weeks
measure: Trail Making Test B (TMT-B) (raw score) measure of cognitive executive function
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Upper extremity functional index (UEFI) self-report of independence in daily activities
timeFrame: Change from baseline at 4 weeks
measure: Chedoke Arm and Hand Activity Inventory (CAHAI) 9 measure of independence in bimanual daily activities
timeFrame: Change from baseline at 4 weeks
measure: Arm range of motion (degrees) measure for shoulder, elbow, wrist and fingers
timeFrame: Change from baseline at 4 weeks
measure: Shoulder strength for deltoid muscles
timeFrame: Change from baseline at 4 weeks
measure: Grasp strength for power grasps and pinch grasps
timeFrame: Change from baseline at 4 weeks
measure: Neuropsychological Assessment Battery NAB Verbal and Visual Attention Module
timeFrame: Change from baseline at 4 weeks
measure: Trail Making Test A (TMT-A) measure of visual and cognitive processing speed
timeFrame: Change from baseline at 4 weeks
measure: Hopkins Verbal Learning Test, Revised (HVLT-R) measure of verbal, visual and memory
timeFrame: Change from baseline at 4 weeks
measure: Boston Naming Test (short form) test of verbal abbility in name (noun) associations
timeFrame: Change from baseline at 4 weeks
measure: Brief Visuospatial Memory Test-Revised (Raw score)
timeFrame: 4 weeks
measure: Beck Depression Inventory II measure of depression severity
timeFrame: Change from baseline at 4 weeks
measure: Subjective evaluation by participant of the experimental therapy
timeFrame: 4 weeks
measure: Blood Pressure measure by medical meter
timeFrame: 4 weeks
measure: Pulse measure by medical meter
timeFrame: 4 weeks
measure: Arm Reach Baseline (computer measure)
timeFrame: 4 weeks
measure: Session duration (computer measure)
timeFrame: 4 weeks
measure: Average game scores (computer measure)
timeFrame: 4 weeks
measure: Arm repetitions (computer measure)
timeFrame: 4 weeks
measure: Finger extension repetitions (computer measure)
timeFrame: 4 weeks
measure: Grasping repetitions (computer measure)
timeFrame: 4 weeks
measure: Training intensity for arm and finger movements per minute (computer measure)
timeFrame: 4 weeks
measure: Cognitive areas trained (computer measure)
timeFrame: 4 weeks
measure: Average game level of difficulty (Computer Measure)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: AM Barrett, MD
role: STUDY_DIRECTOR
References: