Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-Tissue Plasminogen Activator (IV-tPA) (EMISTPA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01331200|
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : February 27, 2013
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Observational Model:||Case Control|
|Official Title:||Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-tPA Infusion.|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
- Level of Patient Disability post-TPA Infusion. [ Time Frame: 30-days post-IV 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|