Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly (Clinical Trial)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

Conditions
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Acute Stroke

Intervention / Treatment
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* Device: Rehabilitation Therapy on Experimental Robotic Table and standard of care
* Genetic: Rehabilitation Therapy as part of Standard of Care (Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (general) Age 50 to 85; Healthy age-matched volunteers diagnosis of CVA that occurred more than 5 days prior and less than 21 days prior (for the stroke survivors group); 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 10o for shoulder and elbow flexion/extension; ability to actively extend fingers at least 5o cognitive skills to participate (Montreal Cognitive Assessment (MoCA) [Nasreddine et al 2005] score 10-30). The adaptive nature of BBC system hardware and therapeutic games can compensate for the motor limitations due to other co-morbidities. Therefore potential participants will not be excluded due to co-morbidities such as Parkinson or arthritis. Subjects may have normal cognition, MCI or dementia, since the games can compensate for diminished cognition through built-in cues and instructions. Inclusion Criterion for the controlled clinical trials arm at Kessler Foundation • Living within 25 miles radius of Kessler Foundation West Orange location. This will facilitate participation in the outpatient clinic training, which follows inpatient rehabilitation. Exclusion Criteria. (general) being younger than 50 or older than 85 years of age previous stroke Stroke that occurred more than 20 days prior to enrolment Inability to actively extend fingers at least 5 degrees; v. 7/8/2018 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 behaviour. inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders). 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Number of subjects: The Investigators expect to enroll up to 40 subjects, inpatients and then outpatients at a research hospital and its outpatient clinic at Kessler Foundation: 20 stroke patients, and 20 will be their spouses/caregivers of subjects participating in the randomized control trials component of this study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation Therapy on Experimental Robotic Table and standard of care<br>10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited for experimental group. The investigators will also recruit the 10 caregivers of the experimental subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states. | Device: Rehabilitation Therapy on Experimental Robotic Table and standard of care<br>* 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<br>* Other names: BrightArm Compact Rehabilitation;|
| Sham Comparator: Rehabilitation Therapy as part of Standard of Care<br>10 elderly 5 days or more post-CVA admitted to Kessler Institute for Rehabilitation/Kessler Foundation) for inpatient rehabilitation will be recruited as a control group. The investigators will also recruit the 10 caregivers of the control subjects. Both experimental and control groups will undergo standardized evaluations for motor function/impairment, cognition and emotive states. | Genetic: Rehabilitation Therapy as part of Standard of Care (Control)<br>* Control group will receive Standard of Care training only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl-Meyer Assessment score for upper extremity function (UE sub-set) | 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. | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Change in Cognitive executive function assessment score | 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. | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Arm Range of Motion | Measurement of active movement range for shoulder, elbow, and wrist. Measured with a mechanical goniometer, higher angular values indicating larger movement range. | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Change in Grasp strength for whole hand (power grasp) and finger pinch | 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. | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Change in Finger Range of Motion measured with mechanical goniometer | finger extension/flexion range for proximal-metacarpal joints. Measured with mechanical goniometer | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Change in Upper extremity functional index (UEFI-20) of independence in activities of daily living | 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. | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Change in Stroke Impact Scale (SIS) measuring impact of stroke on independence in daily activities | 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. | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Change in CAHAI 9 Score of independence in bimanual ADLs | 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) | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Game % Score (baseline and performance) in therapeutic games | 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). | through study completion, an average 5 weeks from enrollment | 
| Game difficulty levels | 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. | through study completion, an average 5 weeks from enrollment | 
| Average game difficulty levels per session | 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. | through study completion, an average 5 weeks from enrollment | 
| Participants' feedback through subjective evaluation of the system | 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). | at 3 weeks and at 5 weeks post enrollment | 
| Change in Verbal attention as measured by the Neuropsychological Assessment Battery | 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. | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Change in visual attention as measured by Neuropsychological Assessment Battery | 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). | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity | 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. | Change between baseline, at 3 weeks and at 5 weeks post enrollment | 
| Caregiver evaluation of experimental system | 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. | at 5 weeks from enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute stroke, sub-acute stage