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

NCT ID: NCT05900999

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2025-10-03

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.

Conditions

Stroke; Exercise

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Survivors of stroke in early stages of recovery

Group Type: EXPERIMENTAL

Feasibility of idle time exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Marquette University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Froedtert Memorial Hospital

Wauwatosa, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 40727538 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R21HD106132-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCW PRO00042316 / MU HR-4044

Identifier Type: -

Identifier Source: org_study_id