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CompletedNCT01331200EMISTPAUpdated Feb 27, 2013

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

An observational study in Ischemic Stroke, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-27.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • ischemic stroke
  • tissue plasminogen activator
  • early mobilization
  • patient safety
  • length of stay
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 20 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)
06

What researchers measure

Primary outcomes

  1. Level of Patient Disability post-TPA Infusion.

    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.

    Time frame: 30-days post-IV tPA infusion

07

Study locations

1 site
  • Mayo Clinic Hospital
    Jacksonville, Florida 32224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01331200
Lead sponsor
Mayo Clinic
First posted
Apr 7, 2011
Start date
Jan 2011
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Feb 27, 2013

Study contacts

Scott M Arnold, PT
principal investigator · Mayo Clinic
Olivia S Chavez, MS, OTR/L
principal investigator · Mayo Clinic
William D Freeman, MD
principal investigator · Mayo Clinic
James Meschia, MD
principal investigator · Mayo Clinic
Lesia Mooney, RN
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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