Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-Tissue Plasminogen Activator (IV-tPA) (EMISTPA)

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01331200
First received: February 4, 2011
Last updated: February 25, 2013
Last verified: February 2013

February 4, 2011
February 25, 2013
January 2011
November 2012   (final data collection date for primary outcome measure)
Level of Patient Disability post-TPA Infusion. [ Time Frame: 30-days post-IV tPA infusion ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01331200 on ClinicalTrials.gov Archive Site
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Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-Tissue Plasminogen Activator (IV-tPA)
Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-tPA Infusion.

The purpose of this study is to study the safety and feasibility of mobilization of acute ischemic stroke patients treated with IV-tPA between 12-24 hours of treatment.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients experiencing 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.

Ischemic Stroke
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2012
November 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01331200
10-007822
Yes
Scott Arnold, PT, Mayo Clinic Florida
Mayo Clinic
Not Provided
Principal Investigator: Scott M Arnold, PT Mayo Clinic Florida
Principal Investigator: Olivia S Chavez, MS, OTR/L Mayo Clinic Florida
Principal Investigator: William D Freeman, MD Mayo Clinic Florida
Principal Investigator: James Meschia, MD Mayo Clinic Florida
Principal Investigator: Lesia Mooney, RN Mayo Clinic Florida
Mayo Clinic
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP