- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04252170
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Feasibility Study)
Study Overview
Status
Conditions
Intervention / Treatment
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);
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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Piscataway, New Jersey, United States, 08854
- PowerBack Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Feasibility study, Stroke Survivors
BAC feasibility study at PowerBack, Piscataway NJ, with stroke patients.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Artificial Intelligence-determined game difficulty level
Time Frame: Through study completion, an average of 3 weeks
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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
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Through study completion, an average of 3 weeks
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Game Score (baseline and performance)
Time Frame: Through study completion, an average of 3 weeks
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BrightBrainer game baseline and performance scores.
Min.
score is 0. Max depends on specific game.
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Through study completion, an average of 3 weeks
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Participants' feedback using 5-point Likert scale
Time Frame: Through study completion, an average of 3 weeks
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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).
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Through study completion, an average of 3 weeks
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Therapist subjective evaluation using 5-point Likert scale
Time Frame: 3 weeks
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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)
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arm Range of Motion
Time Frame: Change from Baseline arm range of motion at 3 weeks
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measurement of active movement initiated by participant using a mechanical goniometer
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Change from Baseline arm range of motion at 3 weeks
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Finger Range of Motion
Time Frame: Change from Baseline finger range of motion at 3 weeks
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finger extension/flexion range using a mechanical goniomter
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Change from Baseline finger range of motion at 3 weeks
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Grasp Strength with Jamar Dynamo-meter
Time Frame: Change from Baseline grasp strength at 3 weeks
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grasp strength measurement using dynamo-meter
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Change from Baseline grasp strength at 3 weeks
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Pinch strength with pinch meter
Time Frame: Change from Baseline at 3 weeks
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Pinch strength measured with fingers placed on a pinch meter
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Change from Baseline at 3 weeks
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Shoulder strength
Time Frame: Change from Baseline shoulder strength at 3 weeks
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Measurement of shoulder strength using calibrated wrist weights
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Change from Baseline shoulder strength at 3 weeks
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Fugl-Meyer Assessment (Upper Extremity sub-scale) score
Time Frame: Change from Baseline Fugl-Meyer Assessment Score at 3 weeks
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Upper Extremity Motor function, score scale is 0 (min) to 66 (max).
Larger score means better outcome.
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Change from Baseline Fugl-Meyer Assessment Score at 3 weeks
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Upper extremity functional index (UEFI) score
Time Frame: Change from Baseline Upper Extremity Functional Inex score at 3 weeks
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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.
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Change from Baseline Upper Extremity Functional Inex score at 3 weeks
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CAHAI 9 Score
Time Frame: Change from Baseline CAHAI 9 score at 3 weeks
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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.
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Change from Baseline CAHAI 9 score at 3 weeks
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Jebsen Test of Hand Function
Time Frame: Change from Baseline Jebsen Test of Hand Function score at 3 weeks
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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).
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Change from Baseline Jebsen Test of Hand Function score at 3 weeks
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Beck Depression Inventory II (BDI II) score
Time Frame: Change from Baseline depression severity at 3 weeks
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participants' depression measure.
Range is 0 (min) to 63 (max).
Lower score indicate better outcomes (less depression).
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Change from Baseline depression severity at 3 weeks
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Verbal attention
Time Frame: Change from Baseline verbal attention at 3 weeks
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Attention module digit span (working memory) in the Neuropsychological Assessment Battery NAB min 0, larger score is better
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Change from Baseline verbal attention at 3 weeks
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Verbal fluency
Time Frame: Change from Baseline verbal fluency at 3 weeks
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verbal fluency test min 0, larger score is better
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Change from Baseline verbal fluency at 3 weeks
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Verbal memory
Time Frame: Change from Baseline verbal learning memory at 3 weeks
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Hopkins Verbal Learning Test, Revised (HVLT-R) min 0, larger is better
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Change from Baseline verbal learning memory at 3 weeks
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Brief Visuospatial Memory Test-Revised
Time Frame: Change from Baseline visuospatial memory at 3 weeks
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A measure of memory function min 50 std of 10, larger score is better
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Change from Baseline visuospatial memory at 3 weeks
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Executive Function Module
Time Frame: Change from Baseline executive function at 3 weeks
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Word Generation min 0, larger is better
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Change from Baseline executive function at 3 weeks
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Cognitive executive function
Time Frame: Change from Baseline Trail Making Test B (TMT-B) Score at 3 weeks
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Trail Making Test B (TMT-B) lMin 50, std of 10, larger number means better outcomes
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Change from Baseline Trail Making Test B (TMT-B) Score at 3 weeks
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Cognitive executive function
Time Frame: Change from Baseline NAB Exec Score at 3 weeks
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NAB Executive Functioning Module min 50, std is 10, larger number means better outcomes
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Change from Baseline NAB Exec Score at 3 weeks
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Visual attention
Time Frame: Change from Baseline visual attention at 3 weeks
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Attention module dots (visual) in the Neuropsychological Assessment Battery NAB
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Change from Baseline visual attention at 3 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Grigore C Burdea, Ph.D., BRIGHT CLOUD INTL CORP
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BCI-10-001
- 5R44AG044639-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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