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Recruiting

NCT Number: NCT07638462

RIsE Stroke Mobility Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

activPAL device

Device

The activPAL measures physical activities. When a Participant moves, it moves generating totals for the time spent lying, sitting, standing and stepping, every second of the day.

Primary outcomes

  1. Achievement of the Johns Hopkins Highest Level of Mobility (JH-HLM) goal based on the Activity Measure for Post-Acute Care (AM-PAC) score

    Time frame: Daily through Day 14

    Proportion of participants who achieve the daily JH-HLM mobility goal derived from the AM-PAC "6-Clicks" score during hospitalization.

Secondary outcomes

  1. Frequency of daily achievement of the JH-HLM goal

    Time frame: Daily through Day 14

    Number of times per day the participant achieves the JH-HLM mobility goal during hospitalization.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeremy Rhoten, MHA, RN

CONTACT

[email protected]

704-355-7403

Sahra Khan, BS

CONTACT

[email protected]

704-355-9434

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

RIsEStroke (Recovery Insights Into Early Mobility Post Stroke)

Acronym: RIsE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jul 10, 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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