PowerBack Rehabilitation
Piscataway, New Jersey, 08854, United States
NCT Number: NCT04252170
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.
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Notify Me50 year–85 year
All sexes
Interventional
Not applicable
Piscataway, New Jersey, 08854, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: BrightArm Compact rehabilitation through games
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
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.
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).
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)
Time frame: Change from Baseline arm range of motion at 3 weeks
measurement of active movement initiated by participant using a mechanical goniometer
Time frame: Change from Baseline finger range of motion at 3 weeks
finger extension/flexion range using a mechanical goniomter
Time frame: Change from Baseline grasp strength at 3 weeks
grasp strength measurement using dynamo-meter
Time frame: Change from Baseline at 3 weeks
Pinch strength measured with fingers placed on a pinch meter
Time frame: Change from Baseline shoulder strength at 3 weeks
Measurement of shoulder strength using calibrated wrist weights
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.
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.
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.
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).
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).
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
Time frame: Change from Baseline verbal fluency at 3 weeks
verbal fluency test min 0, larger score is better
Time frame: Change from Baseline verbal learning memory at 3 weeks
Hopkins Verbal Learning Test, Revised (HVLT-R) min 0, larger is better
Time frame: Change from Baseline visuospatial memory at 3 weeks
A measure of memory function min 50 std of 10, larger score is better
Time frame: Change from Baseline executive function at 3 weeks
Word Generation min 0, larger is better
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
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
Time frame: Change from Baseline visual attention at 3 weeks
Attention module dots (visual) in the Neuropsychological Assessment Battery NAB
Bright Cloud International Corp
Industry
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Feasibility Study)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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