Rehab CARES In USA: Clinical Trial

Study Overview
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Brief Summary
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In Phase 2, Patients in a community-based setting who have had a stroke will be evaluated by rehabilitation professionals and asked to perform a battery of clinical assessments before and after standard of care and robot assisted therapy with Rehab CARES system of simple force-feedback robots that are adapted to deliver single and group therapy.

Detailed Description
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In Phase 2, we will develop the hardware to allow three haptic robots to dock (a gym) and be configured to allow patients to play therapy games alone or collaboratively. We will test the safety and feasibility of the gym in a community-based rehabilitation setting. We will treat 36 patients randomized to either a control group getting standard of care therapy and a robot group receiving standard of care with upper limb therapy being given using the robot gym instead of an occupational therapist. Therapy will occur over 4 weeks with two follow-up assessments. Key milestones will be to show that the robot group has the same or better functional outcomes, motivation, and adverse events as the control group. Also to show that the robot gym is a cost-effective solution to increasing access to quality rehabilitation care in low-resource, community-based settings. Success here will validate this potential solution, justify design changes revealed via user-feedback and a larger clinical trial.

Official Title
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Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES)

Conditions
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Stroke, Hemiplegia

Intervention / Treatment
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* Device: Robot-Assisted Therapy with Rehab CARES system
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 55 and older (based on who is admitted to the CBR site) >3 months post-stroke Stroke diagnosis Diagnosis of hemiparesis as a result of stroke (verified by radiology data) Motor control score on Upper Extremity Fugl-Meyer scale > 15 and < 60; Able to understand and speak Upper arm manual muscle strength scores >1 Pain Scores < 8 based on NIH Pain Intensity Scale Exclusion Criteria: no cerebellum lesions due to stroke severe cognitive function

Ages Eligible for Study
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Minimum Age: 55 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard of Care<br>60 min OT sessions; 3 sessions per week; for 4 weeks;-- augmented Standard therapy - consisting of PT, OT and SLP. Clinical Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2). | Other: Standard of Care<br>* 60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP<br>|
| Experimental: Robot-Assisted Therapy with Rehab CARES system<br>60 min sessions; 3 sessions per week; for 4 weeks;----of Upper Limb therapy using 1 or more affordable robots. Robot sessions can be group play and/or single play. Robot Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2) | Device: Robot-Assisted Therapy with Rehab CARES system<br>* 60 min sessions; 3 sessions per week; for 4 weeks; Patients uses 1 or more affordable robots to exercise the UL with adaptive games assessments as OT; standard of care PT and SLP; Subjects' motor and cognitive impairment will be used to set the game and modes. The game parameters will be adjusted according to motor and cognitive impairment of that station's user while the controller will automatically adjust assisting or resisting torques experienced. The 60 minutes will be broken up into 15-minute training intervals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Motor Control | Measured by Change in Upper Extremity Fugl-Meyer Assessment (UE-FM); scale is out of 66. A lower score means more impaired. | After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up) | 
| Change in Gross Hand Function | Measured by Changes in Box and Block (BnB) Test; metric # of blocks transferred. A higher score means less impaired. | After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up) | 
| Change in Hand Dexterity | Measured by changes in NIH Toolbox 9-Hole Pegboard Dexterity Test; metric time and # of peg transferred over time. A higher number of pegs means less impaired. | After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up) | 
| Upper Extremity Function | Measured by changes in the Neuro-QoL: Upper Extremity Function - Fine Motor, ADL Short Form. Short form is a self-report on 8 items to assesses fine motor function and activity of daily living in upper arm. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Quality of life (Participation) | Measured by changes in the Neuro-QoL: Ability to Participate in Social Role and Activities Short Form. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Quality of life (Satisfaction) | Measured by changes in Neuro-QoL Satisfaction with Social Roles and Activities Short Form. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Motivation | Measured by the Self-Assessment Manikin (SAM) scale which consist of 3 subscales: enjoyment, engagement, and control. Each subscale is from 0 to 9. For enjoyment and engagement the higher score is the better and for control the lower score is better. | at pre, at post-intervention (after 12 sessions), at follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognition | Measured by changes in Montreal Cognitive Assessment (MocA) | After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up) | 
| Visual Spatial Attention | Measured by changes in Color Trails 1.A timed trail making assessment. A faster time result is better. Timed results are normalized by age and education and reported as a normalized z-score. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Executive Function | Measured by performance on Color Trails 2. A timed trail making assessment. A lower time is better. Timed results are normalized by age and education and reported as a normalized z-score. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Active Joint Range of Motion (ROM) | Range of Motion joint testing of the upper limb. Subjects shoulder, elbow, and wrist joint active joint movements are evaluated in the impaired arm. Reported in degrees. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Passive Joint Range of Motion (ROM) | Range of Motion joint testing of the upper limb. Subjects shoulder, elbow, and wrist joint passive joint movements are evaluated in the impaired arm. Reported in degrees. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Grip Strength | Measured by NIH toolbox Grip Strength Test. The amount of pound-force is measured. The higher pound-force is better. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Exertion Level | Measured by score on Borg Exertion Scale. Score is from 0 to 10. 0 is low and 10 is max. Subjects are asked to report pain experienced during a 60 minute session. Exertion between 0 and 6 is expected. | at each of 12 therapy sessions | 
| Pain Level | Measured by score on Visual Analog Pain Scale. Patients indicate a pain score is from 0 to 10. 0 is low and 10 is max. Subjects are asked to report pain experienced during a 60 minute session. Pain < 4 is expected. | at each of 12 therapy sessions | 
| Usability | Measured by score on System Usability Scale. Score is from 0 to 100. 0 is low and 100 is max. A score greater than or equal to 68 is ideal. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Work Load | Measured by NASA TLX Task Demand Scale. The scale consist of 6 questions scored on a likert scale of 0 to 21. The responses are processed to define a workload score. A workload score at or above 37 which is MOD-HIGH is expected. | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Prediction of Motor Function | Measured by R-squared value from regression models of robot metrics from custom assessment tasks with respect to motor measurements of grip strength, gross hand function and fine motor function | at pre, at post-intervention (after 12 sessions), at follow-up | 
| Prediction of Cognitive Function | Measured by R-squared value from regression models of robot metrics from custom assessment tasks with respect to cognitive measurements of overall cognition, attention and executive function. | at pre, at post-intervention (after 12 sessions), at follow-up |