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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44AG044639-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Genesis HealthCare System | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility study, Stroke Survivors | Experimental | BAC feasibility study at PowerBack, Piscataway NJ, with stroke patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation Therapy, Experimental on the BrightArm Compact device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grigore C Burdea, Ph.D. | BRIGHT CLOUD INTL CORP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PowerBack Rehabilitation | Piscataway | New Jersey | 08854 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35416787 | Derived | Burdea G, Kim N, Polistico K, Kadaru A, Grampurohit N, Hundal J, Pollack S. Robotic Table and Serious Games for Integrative Rehabilitation in the Early Poststroke Phase: Two Case Reports. JMIR Rehabil Assist Technol. 2022 Apr 13;9(2):e26990. doi: 10.2196/26990. |
| Label | URL |
|---|---|
| BCI's corporate site | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 5, 2018 | Jan 22, 2020 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 24, 2018 | Jan 22, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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6 will be stroke survivors inpatients at PowerBack, Piscataway NJ, USA.
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |