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Completed

NCT Number: NCT05900999

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

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Exercise Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert Memorial Hospital

Wauwatosa, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Ratio of Average Activity Duration (RAAD)

    Time frame: During device use in an inpatient setting (about 1 to 3 weeks of use).

    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.

  2. System Usability Scale

    Time frame: 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).

    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.

  3. Intrinsic Motivation Inventory (IMI)

    Time frame: After device use in an inpatient setting (after about 1 to 3 weeks of use).

    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.

  4. Quebec User Evaluation of Satisfaction With Technology (QUEST)

    Time frame: 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).

    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.

Sponsors and collaborators

Lead sponsor

Marquette University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Medical College of Wisconsin

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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