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Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252170
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Genesis HealthCare System
Information provided by (Responsible Party):
Dr. Nam H. Kim, Bright Cloud International Corp

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Device: Rehabilitation Therapy, Experimental on the BrightArm Compact device Not Applicable

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);

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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).

  4. 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)


Secondary Outcome Measures :
  1. 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

  2. Finger Range of Motion [ Time Frame: Change from Baseline finger range of motion at 3 weeks ]
    finger extension/flexion range using a mechanical goniomter

  3. Grasp Strength with Jamar Dynamo-meter [ Time Frame: Change from Baseline grasp strength at 3 weeks ]
    grasp strength measurement using dynamo-meter

  4. Pinch strength with pinch meter [ Time Frame: Change from Baseline at 3 weeks ]
    Pinch strength measured with fingers placed on a pinch meter

  5. Shoulder strength [ Time Frame: Change from Baseline shoulder strength at 3 weeks ]
    Measurement of shoulder strength using calibrated wrist weights

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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

  12. Verbal fluency [ Time Frame: Change from Baseline verbal fluency at 3 weeks ]
    verbal fluency test min 0, larger score is better

  13. 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

  14. 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

  15. Executive Function Module [ Time Frame: Change from Baseline executive function at 3 weeks ]
    Word Generation min 0, larger is better

  16. 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

  17. 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

  18. Visual attention [ Time Frame: Change from Baseline visual attention at 3 weeks ]
    Attention module dots (visual) in the Neuropsychological Assessment Battery NAB



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Locations
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United States, New Jersey
PowerBack Rehabilitation
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Bright Cloud International Corp
National Institute on Aging (NIA)
Genesis HealthCare System
Investigators
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Study Chair: Grigore C Burdea, Ph.D. BRIGHT CLOUD INTL CORP
  Study Documents (Full-Text)

Documents provided by Dr. Nam H. Kim, Bright Cloud International Corp:
Informed Consent Form  [PDF] September 5, 2018
Study Protocol  [PDF] August 24, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Nam H. Kim, Director of Engineering, Bright Cloud International Corp
ClinicalTrials.gov Identifier: NCT04252170    
Other Study ID Numbers: BCI-10-001
5R44AG044639-05 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes