NCT Number: NCT04724954
The research project is intended to provide information pertaining to the usability, feasibility and clinical benefit of the BAC system for early sub-acute post CVA rehabilitation, improved cognition and emotive state while in acute inpatient rehabilitation settings (Kessler Foundation) and in an outpatient clinic at the same research hospital.
The randomised controlled trials will take place at Kessler Foundation (West Orange, NJ). It will develop a new longitudinal therapy for elderly stroke survivors who are inpatients and then outpatients at a regional rehabilitation hospital, by adding BAC training to customary care for both inpatients and outpatients. Two systems will be used, improving continuity of care (one each for inpatient and outpatient settings).
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Notify Me50 year–85 year
All sexes
Interventional
Not applicable
Bright Cloud Int'l Corp, North Brunswick, New Jersey, United States
This study targets participants, who had suffered a stroke very recently, 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) bimanual rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities. The study also aims at determining benefit of continuum care training on the BAC in addition to conventional rehabilitation for participants who are inpatients and then outpatients at a rehabilitation hospital and clinic.
Specific aims are:
BAC technology acceptance (all groups); improved motor function for upper extremity; strengthening shoulder and fingers increased range of motion for arms and fingers; improved independence in activities of daily living; improved cognition; improved emotive state; reduction in perceived upper body pain.
Another component of the research project is a small pilot targeting individuals with Parkinson's disease. For them the project is going to:
determine technology acceptance when using the BrightBrainer system; benefit to arms motor function and strengthening when playing BCI therapeutic games; benefit to reduction or tremor when playing games; cognitive benefits improvement in their well-being.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(general)
Subjects may have normal cognition, MCI or dementia, since the games can compensate for diminished cognition through built-in cues and instructions.
Exclusion criteria
. (Controlled study arm)
o Those living outside approximately 25 miles radius of Kessler Foundation West Orange location. Those living too far will have a harder time completing the study as outpatients, as they will probably choose clinics closer to home.
Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). They will also receive Standard of Care rehabilitation
Other names: BrightArm Compact Rehabilitation
Control group will receive Standard of Care training only
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Upper Extremity Mobility and function. It is scored from 0 (minimum score) to 66 (maximum). The higher the score, the better, with 66 indicating normal upper extremity function.
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Trail Making Test B (TMT-B), Neuropsychological Assessment Battery (NAB) Executive Functioning Module. This is a timed test (seconds) with less time indicative of better executive function. No scale.
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Measurement of active movement range for shoulder, elbow, and wrist. Measured with a mechanical goniometer, higher angular values indicating larger movement range.
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Grasp strength and pinch strength measurements using dynamo-meter and pinch meter, respectively. Measured three times for maximal exertion, then averaged. Higher values are better, indicating less hand weakness.
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
finger extension/flexion range for proximal-metacarpal joints. Measured with mechanical goniometer
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Self report of degree of independence in activities of daily living (ADLs). Consists of 20 questions, each scored on a 5 point scale with 0 complete dependence (unable to perform task) to 4 independence in a tasks. Minimum score is 0 (subjects is unable to perform any of the 20 listed tasks to 80 complete independence in all 20 ADLs. Higher score is better outcome.
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Self report of degree of independence in activities of daily living (ADLs). Consists of questions, each scored on a 5 point Likert scale with 1 complete dependence (unable to perform task) to 5 independence in a tasks. Minimum score is 0 (subjects is unable to perform any of the 20 listed tasks to 80 complete independence in all 20 ADLs.
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Chedoke Arm and Hand Activity Inventory, reflecting ADL independence in simulated bimanual ADLs. It consists of 9 tasks, each scored from 1 to 7, where 1 indicates need for total assistance (typical of very weak arms) to 7 indicating total independence in the task. Score range is 9 (minimum) to 63 (maximum)
Time frame: through study completion, an average 5 weeks from enrollment
BrightBrainer game performance %, with each game being scored individually. Scores converted to % of task achieved with range of 0% (worst outcome) to 100% (best outcomes).
Time frame: through study completion, an average 5 weeks from enrollment
BrightBrainer game difficulty settings, indicating game play intensity and challenge. Each game has levels from 1 (easiest) to 10 (hardest). Higher difficulty the subjects is able to play a game at represents a better outcome.
Time frame: through study completion, an average 5 weeks from enrollment
BrightBrainer game difficulty averaged for all games played in a session. Higher average difficulty is indicative of higher function with 1 (easiest) to 10 (hardest). Higher average game difficulty represents a better outcome.
Time frame: at 3 weeks and at 5 weeks post enrollment
Subject feedback and overall ratings on BrightBrainer games, rated on a Likert scale with 1 being least desirable (strongly disagree) to 5 being most desirable rating (strongly agree).
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Attention module digit span tests verbal attention when subject is spoken a sequence of digits, then asked to repeat that sequence. Subjects is spoken 10 sequences of increasing length of digits (between 1 and 9). Score is 1 if sequence is repeated correctly, 0 otherwise. Min score 0 means no spoken digit sequence was repeated correctly, 10 is maximum score, all sequences were repeated correctly by subject.
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Visual attention measured with the dots test of the Neuropsychological Assessment Battery (NAB). This is a delayed recognition span paradigm, in which an array of dots is exposed for a brief period, followed by a blank interference page, followed by a new array with one additional dot. The subject needs to point to the "new" dot. Test administered 3 times, minimum score 0 (none of the new dots found) to maximum 3 (all 3 new dots found).
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
participants' depression measure with higher scores indicating higher severity (worse mood). Score range is 0 to 63, with 0 indicating normal mood (no depression), 1-13 minimal depression, 14-19 mild depression, 20-28 for moderate and 29-63 severe depression.
Time frame: at 5 weeks from enrolment
Rating of system perceived benefit to the person the caregiver cares for. Rating uses a Likert scale with 1 being least desirable outcome and 5 most desirable one.
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Hopkins Verbal Learning Test, Revised (HVLT-R) is a measure of verbal memory. It provides a brief assessment of immediate recall, delayed recall and delayed recognition. Subject is read a series of nouns in several categories, and the asked t repeat these nouns by writing them on a piece of paper. The test is repeated three times, and each time the score is a count of how many nouns were remembered by the subject. The second phase of the test involves delayed recall, which is administered after about 20 minutes from the original test. subject needs to write down all the nouns they remembered and these are counted. There is a maximum of 12 correct responses during delayed recall, so max score is 12
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Brief Visuospatial Memory Test, Revised (BVMT-R) is a measure of visuospatial memory. In three Learning Trials, the subject views a stimulus page showing an geometric figure for 10 seconds, and there are 6 drawings presented. Then the subject is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Raw scores will be used, with higher numbers representing better outcomes. Raw score range is 0 (worst outcome) to 6 (best outcome)
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Montreal Cognitive Assessment (MoCA) is a standardized test of cognitive function. It consists of question in several cognitive domains and has a maximum score of 30. Cognitive function is considered normal for scores above 26, with scores below 18 being indicative of severe cognitive impairments. Higher score is better.
Time frame: Change between baseline, at 3 weeks and at 5 weeks post enrollment
Boston naming test uses line drawings of objects of graded difficulty. Subject is ask to name (i.e. find nouns associated with) the object depicted in the line drawings. Scoring is based on how many objects (out of 80) were correctly named. Higher score means better cognitive function.
Time frame: through study completion, an average 5 weeks from enrollment
Systolic and Diastolic Blood pressures measured before, mid way and at end of every experimental session.
Time frame: through study completion, an average 5 weeks from enrollment
Heart rate measured before, mid way and at end of every experimental session.
Bright Cloud International Corp
Industry
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
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