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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21HD106132-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical College of Wisconsin | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This project evaluates the feasibility of using custom wearable technology and associated procedures to increase activity of the more-involved upper extremity during the earliest stages of recovery from stroke by increasing the amount of therapeutic exercise during idle-time. The proposed research is relevant to public health because it takes steps to mitigate a significant problem in physical rehabilitation using low-cost technology to motivate and monitor idle-time exercise without adding significantly to clinician workloads. The project aligns with the NICHD / NCMRR Research Plan on Rehabilitation by exploiting a mobile health (mHealth) and sensor-based approach to promote health and wellness through participant-engaged, data-driven, individualized care.
The experiments in this proposal will assess the functional utility and subjective patient experience using a personal exercise cueing system designed to reduce learned non-use of the hemiparetic arm in the days, and weeks immediately following stroke. Up to 36 stroke survivors will be asked to participate in 12 practice sessions each lasting approximately 90 minutes. Participants will be asked to perform simple exercises after receiving a vibration cue. In the first four sessions participants will tap the more-involved wrist; in the second four sessions they will passively move the more-involved elbow through a range of motion; in the final four sessions they will actively move the more-involved elbow through a range of motion.
Accelerometers in the wearable devices will monitor motion of the wrist during the exercise sessions. To verify functional utility of the system, the investigators will examine for differences in the duration of arm movement activity in the cued exercise sessions relative to uncued periods. After all the sessions are complete, subjective user experience will be assessed by asking participants to complete a series of surveys wherein they can provide information about their subjective experiences with the wearable device technology. To assess feasibility of long-term follow-up, the investigators will interview the participants two months later regarding how well they use the more-involved arm to perform daily activities. At this time, they will also be asked to wear the devices for two days to assess the ability to measure arm movement activity at follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survivors of stroke in early stages of recovery | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feasibility of idle time exercise | Behavioral | The experiments in this proposal will assess the utility and subjective patient experience performing idle time exercise intervention designed to reduce learned non-use of the hemiparetic arm in the days, and weeks immediately following stroke. Exercise will be cued by wearable technology that provides vibrotactile cues similar to those provided by FitBit devices. Participants will be asked to perform simple exercises after receiving a vibration cue. In the first four sessions they will tap the more-involved wrist; in the second four sessions they will passively move the more-involved elbow through a range of motion; in the final four sessions they will actively move the more-involved elbow through a range of motion. Accelerometers in the wearable devices will monitor motion of the wrist during the exercise sessions. We will interview the participants two months later regarding how well they use the more-involved arm to perform daily activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Average Activity Duration (RAAD) | The RAAD assesses the amount of measured arm activity during cued exercise epochs compared to non-cued epochs. A RAAD value greater than 1.0 indicates that the amount of arm activity in response to Souvenir cues exceeded the amount of activity during non-cued periods of time. | During device use in an inpatient setting (about 1 to 3 weeks of use). |
| System Usability Scale | The System Usability Scale (SUS) assesses the usability of the activity cueing system and monitoring system within the context of encouraging therapeutic arm activity. Scores are provided on a scale ranging from 1 to 100, with higher scores indicating greater perceived usability. Scores greater than 68 are generally considered to indicate "passable" usability. | Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use). |
| Intrinsic Motivation Inventory (IMI) | The IMI assesses subjective experience of motivation in response to the system's vibrotactile cues. IMI comprises 37 questions, with answers provided on a Likert scale (1-7). IMI questions span 6 psychosocial dimensions:
A composite score is computed within each dimension by averaging item responses after reversing specified negative items; a score of 4 separates (+) from (-) experiences. | After device use in an inpatient setting (after about 1 to 3 weeks of use). |
| Quebec User Evaluation of Satisfaction With Technology (QUEST) |
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Inclusion Criteria (General): The goal of this feasibility clinical trial is to assess the functional utility and subjective patient experience using a personal exercise cueing system designed to reduce learned non-use of the hemiparetic arm in the days, and weeks immediately following stroke. We therefore restrict inclusion to stroke survivors in the inpatient rehabilitation unit of Froedtert Memorial Hospital (Milwaukee, WI). Thus, candidate subjects will undergo screening by Dr. McGuire and his team prior to inclusion in the study. Stroke survivors shall have:
Exclusion Criteria (General) include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Memorial Hospital | Wauwatosa | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40727538 | Result | Bassindale K, Golus S, Horder J, Winkoski M, Sytsma M, Morelli WA, Casadio M, McGuire J, Scheidt RA. The Feasibility and User Experience of a Program of Progressive Cued Activity to Promote Functional Upper Limb Activity in the Inpatient Rehabilitation Setting with Follow-Up at Home. Appl Sci (Basel). 2025 Mar 2;15(6):3010. doi: 10.3390/app15063010. Epub 2025 Mar 11. |
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De-identified data have been shared, as described in our recent manuscript (Bassindate et al., 2025: https://www.mdpi.com/2076-3417/15/6/3010).
Anyone with access to the web-links can access the data and analysis codes.
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Recruitment dates: 11/29/2022 through 7/18/2023. Recruitment location: inpatient rehabilitation facility
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| ID | Title | Description |
|---|---|---|
| FG000 | Survivors of Stroke in Early Stages of Recovery | This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke. Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1).
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| ID | Title | Description |
|---|---|---|
| BG000 | Survivors of Stroke in Early Stages of Recovery | This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke. Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | units of measure: years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ratio of Average Activity Duration (RAAD) | The RAAD assesses the amount of measured arm activity during cued exercise epochs compared to non-cued epochs. A RAAD value greater than 1.0 indicates that the amount of arm activity in response to Souvenir cues exceeded the amount of activity during non-cued periods of time. | Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1). | Posted | Mean | Standard Deviation | ratio | During device use in an inpatient setting (about 1 to 3 weeks of use). |
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from enrollment until end of follow-up (up to 6 months post-discharge)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Survivors of Stroke in Early Stages of Recovery | This was a single cohort study. We evaluated the feasibility, functional utility, and subjective user experience of a progressive-challenge cued activity program, delivered via wearable technology, to promote upper limb activity in an inpatient rehabilitation facility during the early days and weeks following stroke. Quantitative movement data was collected using accelerometry (motion trackers worn on both wrists) to estimate compliance with the cue responses. We assessed user experience using validated quantitative surveys that measure motivation to engage with the system, perceptions of system usability, and the degree of user satisfaction while using the technology. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert A. Scheidt, PhD | Marquette University | 414-288-6124 | robert.scheidt@marquette.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2025 | Dec 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2023 | Dec 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Survivors of stroke in early stages of recovery
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|
The QUEST assesses user satisfaction with the system and its delivery by the research team.. The QUEST comprises 12 questions, with answers provided on a Likert scale (1-5). For each question, a score of "1" = not at all satisfied where "5" is "very satisfied". A composite score (min = 1; max = 5) is computed for the QUEST by averaging across all questions. A score of 3 separates (+) from (-) experiences. |
| Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use). |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Montreal Cognitive Assessment (MoCA) | a screening tool to assess cognitive ability (max score: 30; scores 26 to 30 indicate normal cognition; scores 18-25 indicate mild cognitive impairment; scores 10-19 indicate moderate impairment; scores 0-9 indicate severe impairment) | 12 participants withdrew or were withdrawn | Mean | Standard Deviation | numerical score (ordinal) |
|
| Fugl-Meyer Upper Extremity Motor Score | Possible score range: 0 (most impaired) to 66 (unimpaired) | Mean | Standard Deviation | numerical score (ordinal) |
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| Fugl-Meyer Upper Extremity Sensory Score | Possible score range: 0 (most impaired) to 12 (unimpaired) | Mean | Standard Deviation | numerical score (ordinal) |
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|
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| Primary | System Usability Scale | The System Usability Scale (SUS) assesses the usability of the activity cueing system and monitoring system within the context of encouraging therapeutic arm activity. Scores are provided on a scale ranging from 1 to 100, with higher scores indicating greater perceived usability. Scores greater than 68 are generally considered to indicate "passable" usability. | Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1). | Posted | Mean | Standard Deviation | units on a scale | Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use). |
|
|
|
| Primary | Intrinsic Motivation Inventory (IMI) | The IMI assesses subjective experience of motivation in response to the system's vibrotactile cues. IMI comprises 37 questions, with answers provided on a Likert scale (1-7). IMI questions span 6 psychosocial dimensions:
A composite score is computed within each dimension by averaging item responses after reversing specified negative items; a score of 4 separates (+) from (-) experiences. | Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1). | Posted | Mean | Standard Deviation | units on a scale | After device use in an inpatient setting (after about 1 to 3 weeks of use). |
|
|
|
| Primary | Quebec User Evaluation of Satisfaction With Technology (QUEST) | The QUEST assesses user satisfaction with the system and its delivery by the research team.. The QUEST comprises 12 questions, with answers provided on a Likert scale (1-5). For each question, a score of "1" = not at all satisfied where "5" is "very satisfied". A composite score (min = 1; max = 5) is computed for the QUEST by averaging across all questions. A score of 3 separates (+) from (-) experiences. | Of the 42 recruited participants, 12 withdrew or were withdrawn. Reasons for withdrawal included: disliking the vibrotactile cues after initial demonstration with the device (4), disliking the cues after 1-2 days of use (5), transfer of care to outside facility (1), complex therapy schedule (1), and physician withdraw (1). | Posted | Mean | Standard Deviation | units on a scale | Two time points: After device use in an inpatient setting (after about 1 to 3 weeks of use); after device use in home settings (after 2 days of use). |
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| Title | Measurements |
|---|---|
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| perceived choice dimension |
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| perceived competence dimension |
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| pressure/tension dimension |
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