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RIsE Stroke Mobility Study

ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Severe Acute Ischemic Stroke PatientsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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.

Time frame
Daily through Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: