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

NCT05900999 | Completed Results

• 2 other identifiers: MCW PRO00042316 / MU HR-40445R21HD106132-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Exercise

Outcome Measures

Primary Outcomes (4)

• Ratio of Average Activity Duration (RAAD)

  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

  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)

  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: * interest/enjoyment; higher scores = more interest/enjoyment with cued activities * effort/importance; higher scores = more perceived importance and more effort put into performing cued activities * value/usefulness higher scores = more perceived value and usefulness of cued activities * perceived choice; higher scores = greater degree to which participants felt that they had choice in engaging with the cued activities * perceived competence; higher scores = greater degree of competence performing cued activities * pressure/tension; higher scores = more anxiety/tension performing cued activities. 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)

  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).

Study Arms (1)

Survivors of stroke in early stages of recovery

EXPERIMENTAL

Behavioral: Feasibility of idle time exercise

Interventions

Feasibility of idle time exercise BEHAVIORAL

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.

Survivors of stroke in early stages of recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marquette University: lead
• Medical College of Wisconsin: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Froedtert Memorial Hospital

Wauwatosa, Wisconsin, 53226, United States

Location

Related Publications (1)

• Bassindale K, Golus S, Horder J, Winkoski M, Sytsma M, Morelli WA, Casadio M, McGuire J, Scheidt RA. The Feasibility and User Experience of a Program of Progressive Cued Activity to Promote Functional Upper Limb Activity in the Inpatient Rehabilitation Setting with Follow-Up at Home. Appl Sci (Basel). 2025 Mar 2;15(6):3010. doi: 10.3390/app15063010. Epub 2025 Mar 11.

  PMID: 40727538 RESULT

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Robert A. Scheidt, PhD
• Organization: Marquette University

robert.scheidt@marquette.edu

414-288-6124

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Survivors of stroke in early stages of recovery

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 13, 2023
• Study Start: November 29, 2022
• Primary Completion: February 7, 2025
• Study Completion: October 3, 2025
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• 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)
• Access Criteria: Anyone with access to the web-links can access the data and analysis codes.

Locations

US (1)