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NCT07638462NARecruiting

RIsE Stroke Mobility Study

Wake Forest University Health Sciences

Start Date

7/8/2026

Completion Date

4/1/2027

Summary

This study is designed to better understand how patients with severe stroke move during their hospital stay. It will track their activity using a small wearable device (activPAL) along with standard mobility information already collected in clinical care. The goal is to learn what typical movement patterns look like early after a stroke and how well patients meet mobility goals while in the hospital. What is learned from this study may allow determination of how treatment for stroke patients may be improved to improve patient long-term mobility.

Detailed Description

Acute Ischemic Stroke (AIS) is a leading cause of disability and death in the United States. However rehabilitation after stroke has shown to reduce the risk of medical and neurological complications and improved brain recovery. There has been extensive research on early mobilization and advanced therapy after AIS in low to moderate stroke severity patients. There has been little research in the mobility of severe AIS patients. Research studies have utilized several different devices to track movement of subjects. The activPAL device has been used extensively in research studies in a variety of diseases and age groups. The activPAL4pro provides data on posture, limb movement, sleep, sitting and ambulatory movement. For this reason, the activPAL4pro device will be utilized to provide extensive data on our AIS patients.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adults aged 18 years and older * Hospitalized patients with acute ischemic stroke * Initial National Institutes of Health Stroke Scale (NIHSS) score of 10 or greater * Baseline modified Rankin Scale (mRS) score of 0-2 * Current modified Rankin Scale (mRS) score of 3-5 Exclusion Criteria: * Current or expected End-of-life discussions * Current plans for surgical intervention * Patients with pre-mRS of 3-5 * Patients with orthopedic, musculoskeletal, integumentary injury that would prevent safe weight bearing, mobility or equipment use * Uncontrolled cardiorespiratory dysfunction or disease * Active/uncontrolled seizures * Isolation status that would prevent mobility outside of the room * Weight that exceeds the safe limits of mobility equipment

Interventions

DEVICE

activPAL device

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Conditions

Acute Ischemic Stroke

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States