RIsE Stroke Mobility Study

NCT07638462 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB00148157
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; mobility; advanced therapy

Outcome Measures

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

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

  Daily through Day 14

Secondary Outcomes (1)

• Frequency of daily achievement of the JH-HLM goal

  Daily through Day 14

Study Arms (1)

Severe Acute Ischemic Stroke Patients

EXPERIMENTAL

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.

Device: activPAL device

Interventions

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.

Severe Acute Ischemic Stroke Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rahul Karamchandani, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Rhoten, MHA, RN

CONTACT

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

Sahra Khan, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)