RIsE Stroke Mobility Study (RIsE)

RIsEStroke (Recovery Insights Into Early Mobility Post Stroke)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: activPAL device

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy Rhoten, MHA, RN; Phone Number: 704-355-7403; Email: Jeremy.Rhoten@advocatehealth.org
• Study Contact Backup: Name: Sahra Khan, BS; Phone Number: 704-355-9434; Email: Sahra.Khan@Advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of daily achievement of the JH-HLM goal	Number of times per day the participant achieves the JH-HLM mobility goal during hospitalization.	Daily through Day 14

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Rahul Karamchandani, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: stroke; mobility; advanced therapy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: IRB00148157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared because there is no plan to provide participant-level data to external researchers. Data will be used internally for analysis only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No