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

Marquette University

Status

Active, not recruiting

Conditions

Stroke

Exercise

Treatments

Behavioral: Feasibility of idle time exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05900999

HR-4044

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.