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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manumeter with interactive feedback | Experimental | Study participants will receive an experimental manumeter and interactive feedback from the manumeter to monitor and motivate their upper extremity functional activities. |
|
| Manumeter without interactive feedback | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manumeter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Box and Blocks Test (BBT) | To measure unilateral gross manual dexterity | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Reinkensmeyer, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 20, 2024 | |
| Reset | Oct 15, 2024 | |
| Release | Apr 24, 2025 | |
| Reset | May 9, 2025 | |
| Release | Jul 2, 2025 | |
| Reset | Jul 22, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 20, 2024 | Oct 15, 2024 | |||
| Apr 24, 2025 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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 |
| May 9, 2025 |
| Jul 2, 2025 | Jul 22, 2025 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |