Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
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|ClinicalTrials.gov Identifier: NCT04252170|
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Rehabilitation Therapy, Experimental on the BrightArm Compact device||Not Applicable|
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);
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||6 will be stroke survivors inpatients at PowerBack, Piscataway NJ, USA.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Feasibility Study)|
|Actual Study Start Date :||September 15, 2018|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||January 31, 2019|
Experimental: Feasibility study, Stroke Survivors
BAC feasibility study at PowerBack, Piscataway NJ, with stroke patients.
Device: Rehabilitation 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.
Other Name: BrightArm Compact rehabilitation through games
- Artificial Intelligence-determined game difficulty level [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
- Arm Range of Motion [ Time Frame: Change from Baseline arm range of motion at 3 weeks ]measurement of active movement initiated by participant using a mechanical goniometer
- Finger Range of Motion [ Time Frame: Change from Baseline finger range of motion at 3 weeks ]finger extension/flexion range using a mechanical goniomter
- Grasp Strength with Jamar Dynamo-meter [ Time Frame: Change from Baseline grasp strength at 3 weeks ]grasp strength measurement using dynamo-meter
- Pinch strength with pinch meter [ Time Frame: Change from Baseline at 3 weeks ]Pinch strength measured with fingers placed on a pinch meter
- Shoulder strength [ Time Frame: Change from Baseline shoulder strength at 3 weeks ]Measurement of shoulder strength using calibrated wrist weights
- Fugl-Meyer Assessment (Upper Extremity sub-scale) score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
- Verbal attention [ Time Frame: 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
- Verbal fluency [ Time Frame: Change from Baseline verbal fluency at 3 weeks ]verbal fluency test min 0, larger score is better
- Verbal memory [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from Baseline executive function at 3 weeks ]Word Generation min 0, larger is better
- Cognitive executive function [ Time Frame: 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
- Cognitive executive function [ Time Frame: Change from Baseline NAB Exec Score at 3 weeks ]NAB Executive Functioning Module min 50, std is 10, larger number means better outcomes
- Visual attention [ Time Frame: Change from Baseline visual attention at 3 weeks ]Attention module dots (visual) in the Neuropsychological Assessment Battery NAB
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252170
|United States, New Jersey|
|Piscataway, New Jersey, United States, 08854|
|Study Chair:||Grigore C Burdea, Ph.D.||BRIGHT CLOUD INTL CORP|