Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07638462

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

activPAL device

Study Details

Brief 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.

Conditions

Acute Ischemic Stroke

Study ID

NCT07638462

Start date

Jul 8, 2026

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Severe Acute Ischemic Stroke Patients

Hospitalized adult patients with severe acute ischemic stroke who are observed prospectively for mobility patterns during hospitalization using the activPAL4pro device and routine clinical mobility assessments.

Interventions

activPAL 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 outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jeremy Rhoten, MHA, RN

704-355-7403Jeremy.Rhoten@advocatehealth.org

Sahra Khan, BS

704-355-9434Sahra.Khan@Advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 10, 2026

Last verified

May, 2026

Keywords

  • stroke
  • mobility
  • advanced therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-10.