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RIsE Stroke Mobility Study

RIsEStroke (Recovery Insights Into Early Mobility Post Stroke)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07638462
Acronym
RIsE
Enrollment
50
Registered
2026-06-10
Start date
2026-07-08
Completion date
2027-04-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

stroke, mobility, advanced therapy

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.

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.

Interventions

DEVICEactivPAL 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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Achievement of the Johns Hopkins Highest Level of Mobility (JH-HLM) goal based on the Activity Measure for Post-Acute Care (AM-PAC) scoreDaily through Day 14Proportion of participants who achieve the daily JH-HLM mobility goal derived from the AM-PAC "6-Clicks" score during hospitalization.

Secondary

MeasureTime frameDescription
Frequency of daily achievement of the JH-HLM goalDaily through Day 14Number of times per day the participant achieves the JH-HLM mobility goal during hospitalization.

Countries

United States

Contacts

CONTACTJeremy Rhoten, MHA, RN
Jeremy.Rhoten@advocatehealth.org704-355-7403
CONTACTSahra Khan, BS
Sahra.Khan@Advocatehealth.org704-355-9434
PRINCIPAL_INVESTIGATORRahul Karamchandani, MD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026