Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-Tissue Plasminogen Activator (IV-tPA) (EMISTPA)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-tPA Infusion.|
- 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.
|Study Start Date:||January 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
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.
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.
Medical and surgical intensive care units at Mayo Clinic Florida.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331200
|United States, Florida|
|Mayo Clinic Hospital|
|Jacksonville, Florida, United States, 32224|
|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|