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Completed

NCT Number: NCT04252170

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

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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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PowerBack Rehabilitation

Piscataway, New Jersey, 08854, United States

About this study

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);

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rehabilitation Therapy, Experimental on the BrightArm Compact device

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 names: BrightArm Compact rehabilitation through games

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bright Cloud International Corp

Industry

Collaborators

  • Genesis HealthCare System
  • National Institute on Aging (NIA)

Registry information

Official study title

Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Feasibility Study)

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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