FitMi Plus Home Therapy for Stroke Patients

Study Overview
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Brief Summary
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The investigators will investigate the efficacy of a newly developed functional exercise device (FitMi Plus) for people in the chronic stage after a stroke compared to the FitMi Basic (i.e. without functional exercises). FitMi Plus combines objects commonly used during activities of daily living with sensors that can track and record the patient's direction and degree of movement as they perform specific functional tasks described on a computer.

Official Title
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FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke

Conditions
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Cerebral Stroke

Intervention / Treatment
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* Device: FitMi Plus
* Device: FitMi Basic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Experienced 1 or more strokes >6 months prior to enrollment Upper Extremity Fugl-Meyer Score >=15 and <=55 out of 66 Absence of moderate to severe upper extremity pain (<= 4 out of 10 on the visual-analog pain scale) Ability to understand the instructions to operate FitMi products Exclusion Criteria: Lack of concurrent severe medical problems Lack of visual deficits Lack of severe neglect or apraxia No concurrent enrollment in another therapy study

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FitMi Plus<br>Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. | Device: FitMi Plus<br>* A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform.<br>|
| Active Comparator: FitMi Basic<br>Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks. | Device: FitMi Basic<br>* A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Motor Activity Log | A self-reported measure of the quality of movement and amount of use of the impaired upper extremity across a set of activities of daily living. | Baseline, Immediately Post-Treatment, One-Month Post-Treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Upper Extremity Fugl-Meyer | A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks. | Baseline, Immediately Post-Treatment, One-Month Post-Treatment. | 
| Action Research Arm Test | A 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test | Baseline, Immediately Post-Treatment, One-Month Post-Treatment. | 
| Modified Ashworth Spasticity Scale | Tests resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 6 choices. | Baseline, Immediately Post-Treatment, One-Month Post-Treatment | 
| Visual Analog Pain Scale | The Visual Analog Pain Scale is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The scale ranges from 0) no pain to 10) worst possible, unbearable pain | Baseline, Immediately Post-Treatment, One-Month Post-Treatment. | 
| Wearable Activity Tracking | Participants wear a custom-designed wrist-mounted actigrapher (the MiGo, which uses wrist-worn accelerometers to monitor functional use of the upper extremity activity) for a 24 hour period to assess changes in functional activity levels. | Baseline, One-Month Post-Treatment. |