search
Back to results

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

Primary Purpose

Stroke, Exercise

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feasibility of idle time exercise
Sponsored by
Marquette University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Froedtert Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Survivors of stroke in early stages of recovery

Arm Description

Outcomes

Primary Outcome Measures

Ratio of average Activity Duration (RAAD)
The amount of activity during cued exercise epochs compared to non-cued epochs
System Usability Score
A reliable scale for measuring wearable device usability
Intrinsic Motivation Inventory Score
Measure of motivation during the specified activities
Quebec User Evaluation of Satisfaction with assistive Technology score
Measure of user satisfaction with the wearable technology

Secondary Outcome Measures

Motor Activity Log
Measure of amount and quality of arm use in daily activities

Full Information

First Posted
May 16, 2023
Last Updated
June 2, 2023
Sponsor
Marquette University
Collaborators
Medical College of Wisconsin
search

1. Study Identification

Unique Protocol Identification Number
NCT05900999
Brief Title
Addressing Arm Non-use by Encouraging Idle-time Activity During Early Recovery From Stroke
Official Title
Addressing Arm Non-use by Encouraging Idle-time Activity During Early Recovery From Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marquette University
Collaborators
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Survivors of stroke in early stages of recovery
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Survivors of stroke in early stages of recovery
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Feasibility of idle time exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ratio of average Activity Duration (RAAD)
Description
The amount of activity during cued exercise epochs compared to non-cued epochs
Time Frame
through study completion, specifically during device use in inpatient setting (3-12 days)
Title
System Usability Score
Description
A reliable scale for measuring wearable device usability
Time Frame
through study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)
Title
Intrinsic Motivation Inventory Score
Description
Measure of motivation during the specified activities
Time Frame
through study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)
Title
Quebec User Evaluation of Satisfaction with assistive Technology score
Description
Measure of user satisfaction with the wearable technology
Time Frame
through study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)
Secondary Outcome Measure Information:
Title
Motor Activity Log
Description
Measure of amount and quality of arm use in daily activities
Time Frame
through study completion, specifically post-device use in inpatient setting (3-12 days) and again in a home setting (2 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert A Scheidt, PhD
Phone
414-288-6124
Email
robert.scheidt@marquette.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kim D Bassindale, DPT
Phone
262-391-1184
Email
kimberly.bassindale@marquette.edu
Facility Information:
Facility Name
Froedtert Memorial Hospital
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John R McGuire, MD
Phone
414-805-7342
Email
jmcguire@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs