Wearable Device for Motivating Hand Use After Stroke

Study Overview
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Brief Summary
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The goal of this study is to determine the effectiveness of interactive feedback from a wearable device that senses hand function, the Manumeter, in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients

Detailed Description
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In this randomized controlled trial, the investigators will compare two groups of chronic stroke participants Group 1 of study participants will use the Manumeter with interactive functions to monitor and motivate upper extremity functional activity. Group 2 of study participants will use the Manumeter but receive no feedback and will be given the current standard-of-care, a booklet describing a home exercise program for increasing upper extremity exercise. The investigators hypothesize that study participants who interactively monitor functional activity with the Manumeter will improve their upper extremity function significantly more.

Official Title
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An Interactive, Wearable Device for Measuring and Motivating Hand Use After Stroke

Conditions
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Cerebral Stroke

Intervention / Treatment
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* Device: Manumeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age Experienced one or multiple strokes at least six months previously Upper Extremity Fugl-Meyer Score < 60 out of 66 Absence of moderate to severe upper limb pain (< 3 on the a 10 point visual-analog pain scale) Ability to understand the instructions to operate the device Exclusion Criteria: 80 years of age and above Implanted pacemaker moderate to severe pain in affected arm severe tone in affected arm as measured on a standard clinical scale language problem that would prevent from properly understanding instructions currently pregnant difficulty in understanding or complying with the instructions given by the experimenter inability to perform the experimental task that will be studied

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Manumeter with interactive feedback<br>Study participants will receive an experimental manumeter and interactive feedback from the manumeter to monitor and motivate their upper extremity functional activities. | Device: Manumeter<br>* A manumeter is a first-of-its-kind magnetic sensor to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The study participants will wear a small magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband can detect arm accelerations.<br>|
| Experimental: Manumeter without interactive feedback<br>Study participants will receive an experimental manumeter but receive no feedback from the manumeter, and will be given the current standard-of-care for increasing upper extremity exercise booklet to perform at home. | Device: Manumeter<br>* A manumeter is a first-of-its-kind magnetic sensor to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The study participants will wear a small magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband can detect arm accelerations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Blocks Test (BBT) | To measure unilateral gross manual dexterity | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test (ARAT) | To evaluate specific changes in arm function from handling objects differing in size, weight and shape | 3 months | 
| Fugl-Meyer Motor Assessment (FM) | To assess motor functioning, balance, joint functioning thru performance based movement | 3 months | 
| Motor Activity Log (MAL) | To evaluate self-reported functional use of the limb | 3 months | 
| Amount of upper extremity activity | To evaluate the daily amount of upper extremity activity by using the wearable sensor | 3 months |