Stroke
Conditions
Brief summary
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
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);
Interventions
DEVICERehabilitation 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.
Sponsors
National Institute on Aging (NIA)
Genesis HealthCare System
Bright Cloud International Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
6 will be stroke survivors inpatients at PowerBack, Piscataway NJ, USA.
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Artificial Intelligence-determined game difficulty level | Through study completion, an average of 3 weeks | 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 |
| Game Score (baseline and performance) | Through study completion, an average of 3 weeks | BrightBrainer game baseline and performance scores. Min. score is 0. Max depends on specific game. |
| Participants' feedback using 5-point Likert scale | Through study completion, an average of 3 weeks | 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). |
| Therapist subjective evaluation using 5-point Likert scale | 3 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder strength | Change from Baseline shoulder strength at 3 weeks | Measurement of shoulder strength using calibrated wrist weights |
| Fugl-Meyer Assessment (Upper Extremity sub-scale) score | Change from Baseline Fugl-Meyer Assessment Score at 3 weeks | Upper Extremity Motor function, score scale is 0 (min) to 66 (max). Larger score means better outcome. |
| Upper extremity functional index (UEFI) score | Change from Baseline Upper Extremity Functional Inex score at 3 weeks | 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. |
| CAHAI 9 Score | Change from Baseline CAHAI 9 score at 3 weeks | 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. |
| Jebsen Test of Hand Function | Change from Baseline Jebsen Test of Hand Function score at 3 weeks | 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). |
| Beck Depression Inventory II (BDI II) score | Change from Baseline depression severity at 3 weeks | participants' depression measure. Range is 0 (min) to 63 (max). Lower score indicate better outcomes (less depression). |
| Arm Range of Motion | Change from Baseline arm range of motion at 3 weeks | measurement of active movement initiated by participant using a mechanical goniometer |
| Verbal fluency | Change from Baseline verbal fluency at 3 weeks | verbal fluency test min 0, larger score is better |
| Verbal memory | Change from Baseline verbal learning memory at 3 weeks | Hopkins Verbal Learning Test, Revised (HVLT-R) min 0, larger is better |
| Brief Visuospatial Memory Test-Revised | Change from Baseline visuospatial memory at 3 weeks | A measure of memory function min 50 std of 10, larger score is better |
| Executive Function Module | Change from Baseline executive function at 3 weeks | Word Generation min 0, larger is better |
| Cognitive executive function | Change from Baseline Trail Making Test B (TMT-B) Score at 3 weeks | Trail Making Test B (TMT-B) lMin 50, std of 10, larger number means better outcomes |
| Visual attention | Change from Baseline visual attention at 3 weeks | Attention module dots (visual) in the Neuropsychological Assessment Battery NAB |
| Verbal attention | Change from Baseline verbal attention at 3 weeks | Attention module digit span (working memory) in the Neuropsychological Assessment Battery NAB min 0, larger score is better |
| Finger Range of Motion | Change from Baseline finger range of motion at 3 weeks | finger extension/flexion range using a mechanical goniomter |
| Grasp Strength with Jamar Dynamo-meter | Change from Baseline grasp strength at 3 weeks | grasp strength measurement using dynamo-meter |
| Pinch strength with pinch meter | Change from Baseline at 3 weeks | Pinch strength measured with fingers placed on a pinch meter |
Countries
United States
Outcome results
None listed