How well stroke patients move early after a severe stroke using a wearable
Official title: RIsEStroke (Recovery Insights Into Early Mobility Post Stroke)
Run by Wake Forest University Health Sciences · NCT07638462 · Data updated 2026-11-12
This study tests how adults with severe acute ischemic stroke move during their hospital stay by wearing a small activity monitor to see early mobility patterns.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | July 8, 2026 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT07638462 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older hospitalized with acute ischemic stroke and NIHSS score ≥10, with baseline mRS 0-2 and current mRS 3-5.
✕Probably not a fit
Patients who are not ambulatory or cannot safely use the wearable device due to medical or physical constraints may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with acute ischemic stroke and a high initial stroke severity will wear the activPAL4pro device to collect data on posture, movement, and sleep while receiving standard care. The study aims to describe typical early mobility patterns and how well patients meet mobility goals in the hospital. Data from the wearables will be used alongside routine mobility assessments to understand how early movement relates to recovery potential. This is an observational, device-based add-on to standard care, focusing on mobility insights to inform future treatment approaches.
Why it matters
Potential benefit: Gaining a clearer picture of early mobility after severe stroke could help tailor rehabilitation strategies to improve long-term mobility.
How similar studies have gone: Wearable devices like activPAL have been used in stroke mobility research, supporting feasibility, though studies in severe AIS are less common.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Rahul Karamchandani, MD — Wake Forest University Health Sciences
- Study coordinator: Jeremy Rhoten, MHA, RN
- Email: Jeremy.Rhoten@advocatehealth.org
- Phone: 704-355-7403
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.