Acute Ischemic StrokeRIsENCT07638462
RIsE Stroke Mobility Study
A study testing activPAL device in people with Acute Ischemic Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- activPAL device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2026to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- activPAL device
- Keywords
- stroke, mobility, advanced therapy
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activPAL deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: activPAL device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily through Day 14
Secondary outcomes (1)
Frequency of daily achievement of the JH-HLM goal
Number of times per day the participant achieves the JH-HLM mobility goal during hospitalization.
Measured: Daily through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start8 Jul 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rahul Karamchandani, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638462
- Sponsor's protocol ID
- IRB00148157
- Acronym
- RIsE
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.