NCT05900999

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

Completed NA Results posted Last updated 16 January 2026

What this trial tests

NA trial testing Feasibility of idle time exercise in Stroke in 42 participants. Completed in 3 October 2025.

Timeline

29 November 2022

Primary endpoint
7 February 2025

3 October 2025

Quick facts

Lead sponsor	Marquette University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	42
Start date	29 November 2022
Primary completion	7 February 2025
Estimated completion	3 October 2025
Sites	1 location across United States

Drugs / interventions tested

• Feasibility of idle time exercise

Conditions studied

• Stroke — all drugs for Stroke →
• Exercise — all drugs for Exercise →

Sponsor

Marquette University

Who can join

18 and older, any sex, with Stroke or Exercise. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ratio of Average Activity Duration (RAAD) Primary · 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.

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	1.223	± 0.63

System Usability Scale Primary · 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.

SUS obtained after using the device in an inpatient setting

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	80.1	± 13.8

SUS obtained after using the device in home settings

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	83.3	± 15.2

Intrinsic Motivation Inventory (IMI) Primary · 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 h

interest/enjoyment dimension

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	4.9	± 1.3

effort/importance dimension

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	5.4	± 1.4

value/usefulness dimension

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	6.2	± 0.9

perceived choice dimension

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	6.0	± 0.9

perceived competence dimension

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	5.8	± 1.2

pressure/tension dimension

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	2.8	± 1.0

Quebec User Evaluation of Satisfaction With Technology (QUEST) Primary · 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.

QUEST post-device use in an inpatient setting

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	4.52	± 0.46

QUEST after use in home settings

Group	Value	95% CI
Survivors of Stroke in Early Stages of Recovery	4.5	± 0.5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.