MedPath

Addressing Arm Non-use by Encouraging Idle-time Activity During Early Recovery from Stroke

Not Applicable
Active, not recruiting
Conditions
Stroke
Exercise
Interventions
Behavioral: Feasibility of idle time exercise
Registration Number
NCT05900999
Lead Sponsor
Marquette University
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
36
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Survivors of stroke in early stages of recoveryFeasibility of idle time exercise-
Primary Outcome Measures
NameTimeMethod
System Usability Scorethrough study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)

A reliable scale for measuring wearable device usability

Intrinsic Motivation Inventory Scorethrough study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)

Measure of motivation during the specified activities

Quebec User Evaluation of Satisfaction with assistive Technology scorethrough study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)

Measure of user satisfaction with the wearable technology

Ratio of average Activity Duration (RAAD)through study completion, specifically during device use in inpatient setting (3-12 days)

The amount of activity during cued exercise epochs compared to non-cued epochs

Secondary Outcome Measures
NameTimeMethod
Motor Activity Logthrough 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

Trial Locations

Locations (1)

Froedtert Memorial Hospital

🇺🇸

Wauwatosa, Wisconsin, United States

© Copyright 2025. All Rights Reserved by MedPath