- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01331200
Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-Tissue Plasminogen Activator (IV-tPA) (EMISTPA)
Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-tPA Infusion.
Study Overview
Status
Conditions
Detailed Description
Abstract:
Introduction
Historical precedence exists demonstrating that early intensive care unit (ICU) mobilization of patients reduces risks of complication and lengths of hospital stay, and may improve long-term health status of patients.
Objective
To determine the safety of early mobilization by physical and/or occupational therapy in acute ischemic stroke patients within 24-hours of IV-tPA infusion and to examine if early mobilization leads to shortened ICU and hospital length of stay.
Methods
Prospective study of incidence of adverse response and functional mobility status of study patients mobilized by occupational and/or physical therapy between 12- 24 hours after IV-tPA infusion with comparison of ICU and hospital Length of Stay data between study group and pre-study patients who were mobilized by occupational and/or physical therapy services at no pre-determined time after IV-tPA infusion. Additionally, patients will be contacted by study personnel approximately 3 to 5-days and 30-days post-infusion for completion of Modified Rankin Scale stroke disability survey as follow up of stroke recovery.
Setting
Medical and surgical intensive care units at Mayo Clinic Florida.
Patients
All patients with acute ischemic stroke who receive intravenous tissue plasminogen activator (IV-tPA) infusion, survive to discharge from the hospital, are hemodynamically stable, and are mobilized by physical and/or occupational therapy within 24 hours post-tPA infusion.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients post acute ischemic stroke that have been treated with intravenous tissue plasminogen activator (IV-tPA)
- 13 hours have elapsed since initiation of intravenous TPA infusion
- Patients are hemodynamically stable (e.g., not on vasopressors or antihypertensive drips or requiring multiple IV PRN boluses of either medication)
- Patient is able to actively engage in the evaluation
Exclusion Criteria:
- Patients with femoral sheaths or recent removal of femoral sheaths
- Patients who are hemodynamically unstable, with active bleeding from lines, catheters, INT site or wounds or angioedema
- Electrocardiogram showing (HR>100)
- Vital signs (HR > 100, SBP <90 or >180, DBP <70 or > 105)
- Patients experiencing marked diaphoresis, facial pallor, intense anxious or painful facial expression (especially in aphasic patients)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of Patient Disability post-TPA Infusion.
Time Frame: 30-days post-IV tPA infusion
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Study participants will be contacted at approximately 3 to 5-days and 30-days post-IV tPA infusion to capture level of disability by use of Modified Rankin Scale.
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30-days post-IV tPA infusion
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Meschia, MD, Mayo Clinic
- Principal Investigator: Scott M Arnold, PT, Mayo Clinic
- Principal Investigator: Olivia S Chavez, MS, OTR/L, Mayo Clinic
- Principal Investigator: William D Freeman, MD, Mayo Clinic
- Principal Investigator: Lesia Mooney, RN, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-007822
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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