Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900999
Status:
RECRUITING
Last Update Posted:
2023-06-13
First Post:
2023-05-16
Brief Title:
Addressing Arm Non-use by Encouraging Idle-time Activity During Early Recovery From Stroke
Sponsor:
Marquette University
Organization:
Marquette University
Study Overview
Official Title:
Addressing Arm Non-use by Encouraging Idle-time Activity During Early Recovery From Stroke
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None