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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01EB027777-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Massachusetts, Amherst | OTHER |
| University of Maryland, College Park | OTHER |
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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The goal of this clinical trial is to learn if wearable sensor data visualization on smartphones can improve the use of the stroke-affected limb during everyday activities. Chronic stroke survivors (>12 months from onset) ages 18-80 years old with residual upper extremity motor impairments may be eligible to participate. The main question it aims to answer is:
Does the mobile health (mHealth) intervention help to improve the use of the stroke-affected upper-limb during daily living?
The study is designed so each participant serves as their own control. Researchers will compare information from the baseline and intervention time periods to see if visualizing the data on the smartphone impacts the participant's daily use of the arm.
Participants will be asked to wear a set of wearable ring and wrist sensors and interact with a custom-designed smartphone app, aiming to increase the use of their stroke-affected limb during daily activities as much as possible. They will receive feedback from the app, communicate with study therapists, participate in goal setting, complete clinical assessments, and share about their experience using the system during a virtual interview.
To test the efficacy of the mHealth intervention elements (i.e., feedback, goal setting, and communication), we will use the A (Baseline)-B (Intervention) design. The A-B design allows for an analysis of the effects of the introduction of the intervention elements, while providing all participants an opportunity to experience the novel intervention components.
During the baseline phase (week 0 - week 1), study participants will wear the wrist and index finger-worn sensors, bilaterally, for a total of 7 days. The app will also allow study participants to self-annotate their activities approximately every 90 minutes.
During the intervention phase (week 1 - week 4), study participants will be asked to wear the wrist and/or index finger-worn sensors, bilaterally, for the next 3 weeks, similar to the baseline phase. The primary difference is that the patient will be asked to actively interact with the Intervention app, which will provide visualization of the patient's limb activity level. The platform will send auto-reminders to subjects every day at their preferred morning time to remind them to wear the wearable sensors and interact with the app. Using the sensor data collected from the wearable devices, the app will visualize the daily and weekly summary of the participants' limb activity data and the goals set by the therapist and patient. Additionally, the app will allow participants to annotate their activities and show the annotations along with the data. During the intervention phase, the participant will engage in 2 separate Zoom calls with a research therapist to 1) review the limb activity during the week, 2) discuss barriers to using the more impaired arm and ways to overcome them, 3) adjust the goal setting for the following week, and 4) document the discussions.
Clinical assessments will be completed after enrollment and following the intervention phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHealth Intervention | Experimental | Members of this group will receive the wearable sensors and mHealth smartphone application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth | Device | The experimental design is composed of two phases: baseline and intervention. During the first week (baseline), subjects will wear sensors, but no additional features (e.g., feedback, goal-setting, and weekly Zoom calls with clinicians) will be provided. For the next three weeks (intervention), subjects will wear sensors and have access to all intervention features, including weekly Zoom calls and goal-setting with clinicians. They will be encouraged to use the more impaired arm as much as possible. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Activity Log - Amount of Use | This outcome measure assesses upper extremity function and use through patient report. Items are scored using a 6-point ordinal scale. For the Amount Scale, 0=the weaker arm was not used at all for that activity (not used), while 5=the weaker arm was used as often as before the stroke (same as pre-stroke). The score is calculated by adding the rating scores for each item and dividing by the number of items asked. | Week 0, Week 1, Week 4 |
| Use Duration | This measure evaluates the duration for which a patient actively uses their stroke-affected limb during daily activities, as recorded by a wearable accelerometer placed on the stroke-affected index finger. The unit is minutes, with a range from 0 to 3600. A value of 0 indicates no use of the stroke-affected limb during the 24-hour period, while 3600 indicates continuous activity of the limb throughout the day. To compute Use Duration, the continuous accelerometer data is segmented into short intervals (e.g., one second), and the duration is calculated by counting the time intervals where the acceleration magnitude exceeds a threshold (e.g., > 1.134 g). | From enrollment to the end of the intervention period at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Activity Log - Quality of Movement | This outcome measure assesses upper extremity function and use through patient report. Items are scored using a 6-point ordinal scale. For the How Well Scale, 0=the weaker arm was not used at all for that activity (not used), while 5=the ability to use the weaker arm for that activity was as good as before the stroke (normal). The score is calculated by adding the rating scores for each item and dividing by the number of items asked. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment, Upper Extremity - Motor | This is a motor function assessment for stroke survivors who have hemiplegia. Items are scored on a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. Higher scores are indicative of higher function. Maximum score=66. | Week 0, Week 1, Week 4 |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathy Piela, PT, DPT | Contact | 617-952-6388 | kpiela@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Director of Motion Analysis Laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital, Motion Analysis Laboratory | Recruiting | Charlestown | Massachusetts | 02474 | United States |
This is not included in the study participant consent form.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| D001247 | Asthenia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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We will use the A (Baseline)-B (Intervention) design. Each participant will serve as their own control.
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| Week 0, Week 1, Week 4 |
| Use Ratio | This measure compares the activity levels of the stroke-affected limb to the less-affected limb. The range is from -log(3600) to log(3600). where -log(3600) indicates exclusive use of the stroke-affected limb, log(3600) indicates exclusive use of the less-affected limb, and 0 represents equal use of both limbs. Use Ratio is computed by first determining the Use Duration for both the stroke-affected and less-affected limbs using wearable accelerometers placed on their respective index fingers. The relationship is then calculated as the logarithm of the ratio of Use Durations: log(stroke-affected use duration/less-affected use duration). | From enrollment to the end of the intervention period at 4 weeks |
| Wolf Motor Function Test - Functional Ablility |
This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Functional ability scores are assigned using a 6-point ordinal scale, and the maximum score is 75. A score of 0=does not attempt with the involved arm and a score of 5=arm does participate; movement appears to be normal. Higher scores are indicative of higher function. |
| Week 0, Week 1, Week 4 |
| Wolf Motor Function Test - Performance Time | This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Performance time is measured in seconds, with up to 120 seconds allowed. | Week 0, Week 1, Week 4 |
| Box and Block Test | The test is an assessment of unilateral gross manual dexterity. It is performed with each hand separately, the stroke-affected hand and the non-affected hand. The scored is calculated by counting the number of blocks that were carried over the partition from one side of the box to the other side of the box in 1 minute. Higher scores are indicative of better gross manual dexterity. | Week 0, Week 1, Week 4 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |