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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05900999
• Other study ID #: HR-4044
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Marquette University
• Contact: Robert A Scheidt, PhD
• Phone: 414-288-6124
• Email: robert.scheidt[@]marquette.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Stroke

Intervention

Behavioral:
• Feasibility of idle time exercise
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.

Locations

Country	Name	City	State
United States	Froedtert Memorial Hospital	Wauwatosa	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Marquette University	Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of average Activity Duration (RAAD)	The amount of activity during cued exercise epochs compared to non-cued epochs	through study completion, specifically during device use in inpatient setting (3-12 days)
Primary	System Usability Score	A reliable scale for measuring wearable device usability	through study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)
Primary	Intrinsic Motivation Inventory Score	Measure of motivation during the specified activities	through study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)
Primary	Quebec User Evaluation of Satisfaction with assistive Technology score	Measure of user satisfaction with the wearable technology	through study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)
Secondary	Motor Activity Log	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)