Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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);

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

Conditions
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Stroke

Intervention / Treatment
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* Device: Rehabilitation Therapy, Experimental on the BrightArm Compact device


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: 6 will be stroke survivors inpatients at PowerBack, Piscataway NJ, USA.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility study, Stroke Survivors<br>BAC feasibility study at PowerBack, Piscataway NJ, with stroke patients. | Device: Rehabilitation Therapy, Experimental on the BrightArm Compact device<br>* 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.<br>* Other names: BrightArm Compact rehabilitation through games;|

What is the study measuring?
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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 |