Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly
- Conditions
- Stroke
- Interventions
- Device: Rehabilitation Therapy, Experimental on the BrightArm Compact device
- Registration Number
- NCT04252170
- Lead Sponsor
- 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.
- 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);
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Feasibility study, Stroke Survivors Rehabilitation Therapy, Experimental on the BrightArm Compact device BAC feasibility study at PowerBack, Piscataway NJ, with stroke patients.
- Primary Outcome Measures
Name Time Method Game Score (baseline and performance) Through study completion, an average of 3 weeks BrightBrainer game baseline and performance scores. Min. score is 0. Max depends on specific game.
Participants' feedback using 5-point Likert scale 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).
Artificial Intelligence-determined game difficulty level 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
Therapist subjective evaluation using 5-point Likert scale 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
Name Time Method Arm Range of Motion Change from Baseline arm range of motion at 3 weeks measurement of active movement initiated by participant using a mechanical goniometer
Grasp Strength with Jamar Dynamo-meter Change from Baseline grasp strength at 3 weeks grasp strength measurement using dynamo-meter
Pinch strength with pinch meter Change from Baseline at 3 weeks Pinch strength measured with fingers placed on a pinch meter
Jebsen Test of Hand Function 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).
Verbal attention 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
CAHAI 9 Score 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.
Fugl-Meyer Assessment (Upper Extremity sub-scale) score 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.
Upper extremity functional index (UEFI) score 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.
Brief Visuospatial Memory Test-Revised Change from Baseline visuospatial memory at 3 weeks A measure of memory function min 50 std of 10, larger score is better
Finger Range of Motion Change from Baseline finger range of motion at 3 weeks finger extension/flexion range using a mechanical goniomter
Shoulder strength Change from Baseline shoulder strength at 3 weeks Measurement of shoulder strength using calibrated wrist weights
Beck Depression Inventory II (BDI II) score 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).
Verbal fluency Change from Baseline verbal fluency at 3 weeks verbal fluency test min 0, larger score is better
Verbal memory Change from Baseline verbal learning memory at 3 weeks Hopkins Verbal Learning Test, Revised (HVLT-R) min 0, larger is better
Cognitive executive function Change from Baseline NAB Exec Score at 3 weeks NAB Executive Functioning Module min 50, std is 10, larger number means better outcomes
Visual attention Change from Baseline visual attention at 3 weeks Attention module dots (visual) in the Neuropsychological Assessment Battery NAB
Executive Function Module Change from Baseline executive function at 3 weeks Word Generation min 0, larger is better
Trial Locations
- Locations (1)
PowerBack Rehabilitation
🇺🇸Piscataway, New Jersey, United States