Addressing Arm Non-use by Encouraging Idle-time Activity During Early Recovery From Stroke
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Wisconsin
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Wauwatosa, Wisconsin, United States, 53226
- Froedtert Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- had a unilateral stroke within the last 30 days;
- ability to give informed consent and be able to follow two-stage instructions;
- a broad range of motor impairment as assessed using the upper extremity portion of the Fugl-Meyer Motor Assessment (i.e., UE-FM score <= 50 out of a possible 66);
- age ≥ 18 yr. of age.
Exclusion Criteria (General) include:
- Inability of subjects to give informed consent or follow two-stage instructions;
- concurrent illness or severe pain limiting the capacity to conform to study requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Survivors of stroke in early stages of recovery
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratio of Average Activity Duration (RAAD)
Time Frame: During device use in an inpatient setting (about 1 to 3 weeks of use).
|
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
Time Frame: 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).
|
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)
Time Frame: After device use in an inpatient setting (after about 1 to 3 weeks of use).
|
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)
Time Frame: 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).
|
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).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Activity Log
Time Frame: through study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)
|
Measure of amount and quality of arm use in daily activities
|
through study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCW PRO00042316 / MU HR-4044
- 5R21HD106132-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
- https://doi.org/10.5281/zenodo.14990338 (4 March 2025 onward; no end date).
- https://www.mdpi.com/2076-3417/15/6/3010 (select Download -> Download Supplementary Material)
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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