Home Exercise With Wearable Sensors

Study Overview
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Brief Summary
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Repetitious motor therapy has been shown to yield the greatest improvement in motor function in those who suffer hemiplegia because of a neurological impairment. However, motor therapy remains largely clinically based due to the absence of quantitative home-based therapy technology or equipment. With the current lack of accountability, patient adherence to home exercise physical therapy programs is estimated to be as low as 35%. In response, some companies have extended the applications of their motion capture devices to be used for home-based physical therapy. However, the technologies often have not passed their initial stages of development. In contrast, a company named 4D Motion is actively working alongside the Restorative Neurology Clinic at Burke Medical Research Institute to develop a motion capture system tailored to the motor rehabilitation of hemiplegic stroke patients. This device is driven by a user's active range of motion and does not impart electrical or mechanical stimulation to the user. The device does not force the user beyond their active range of motion and does not apply resistance to motion that limits the user's capability. The 4D Motion capture system is only used to record what the patient is doing and to promote adherence to their prescribed physical therapy plan.

Official Title
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Home-based Exercises Using Wearable Motion Sensors for Community-dwelling Stroke Survivors With Hemiparesis

Conditions
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Stroke, Hemiparesis

Intervention / Treatment
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* Device: Training with 4D Motion Capture Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to follow 1-2 step commands Neurological deficit leading to hemiparesis or hemiplegia with a sensorimotor deficit Fugl Meyer Upper Extremity Score of at least 20/66 Exclusion Criteria: Has a metal implant anywhere on or inside the body Fixed contracture or deformity of affected upper extremity Individuals with bilateral stroke (i.e. if both arms are affected) Unable to tolerate repetitious movement as determined by Likert Scale Rating greater than 5 out of 10

Ages Eligible for Study
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Minimum Age: 18 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training with 4D Motion Capture Device<br>Participants will be given access to a tablet-based application and non-invasive sensors that will track movements of the upper extremity and will prompt daily exercise. Participants will be encouraged to use the device daily for 30 consecutive days, up to one hour per day. | Device: Training with 4D Motion Capture Device<br>* Participants will be given access to a tablet-based application and non-invasive sensors that will track movements of the upper extremity and will prompt daily exercise. Participants will be encouraged to use the device daily for 30 consecutive days, up to one hour per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment days completed | Measure of the number of days that the participant adheres to the prescribed therapy plan (completion of 1000 movements). Goal is to have participants perform 1000 movements per day over 30 days. | From day 1 to day 30 of intervention | 
| Change in active range of motion of shoulder, elbow, and wrist | Maximum angular position about a joint that the participant can reach without assistance. | From day 1 to day 30 of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl Meyer upper extremity assessment | Clinical scale that measures upper extremity impairment in stroke patients | From day 1 to day 30 of intervention | 
| Physical Activity Enjoyment Scale | Survey of how well a participant enjoyed the study treatment. | Day 30 of intervention | 
| System usability survey | Survey of user-friendliness of software and device | Day 30 of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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outpatient, wearable sensors, home exercise