Clinical trial NCT01331200: Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-Tissue Plasminogen Activator (IV-tPA)
Official title: Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-tPA Infusion.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: ischemic stroke
tissue plasminogen activator
early mobilization
patient safety
length of stay
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Level of Patient Disability post-TPA Infusion.
timeFrame: 30-days post-IV tPA infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Hospital
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Scott M Arnold, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Olivia S Chavez, MS, OTR/L
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: William D Freeman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: James Meschia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Lesia Mooney, RN
role: PRINCIPAL_INVESTIGATOR
References: