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RECRUITINGOBSERVATIONAL

A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development

A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study will monitor patients during the first year following their stroke. Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain. The main aim of the study will be to find out how many of those who experience their first-ever stroke then go on to develop spasticity that would benefit from treatment with medication. Spasticity is a common post-stroke condition that causes stiff or ridged muscles. The results of this study will provide a standard guideline on the best way to monitor the development of post-stroke spasticity.

Who May Be Eligible (Plain English)

Who May Qualify: - Participant must be aged 18 to 90 years at the time of providing willing to sign a consent form - First-ever clinical stroke, defined according to World Health Organization criteria as rapidly developing clinical signs of focal (at times global) disturbance of cerebral function lasting more than 24 hours, within the past 4 weeks; - Confirmed paresis of the arms and/or legs which does not resolve within 1 day, according to the NIHSS score (a score of \> 0 on Question 5 or 6 of the scale) within 2 weeks after the stroke - Capable of giving willing to sign a consent form which includes compliance with the requirements and restrictions listed in the ICF and in this protocol Who Should NOT Join This Trial: - Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale \>2); - Presence of significant/major neurological impairment that might affect muscle tone (other than limb paresis); - Severe multi-impairment or diminished physical condition before stroke that could have caused paresis/spasticity/motor deficit per investigator judgement; - Life expectancy of less than 12 months as a result of severity of stroke or other illnesses (e.g. cardiac disease, malignancy, etc.) - Participation in any interventional study Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participant must be aged 18 to 90 years at the time of providing informed consent * First-ever clinical stroke, defined according to World Health Organization criteria as rapidly developing clinical signs of focal (at times global) disturbance of cerebral function lasting more than 24 hours, within the past 4 weeks; * Confirmed paresis of the arms and/or legs which does not resolve within 1 day, according to the NIHSS score (a score of \> 0 on Question 5 or 6 of the scale) within 2 weeks after the stroke * Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol Exclusion Criteria: * Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale \>2); * Presence of significant/major neurological impairment that might affect muscle tone (other than limb paresis); * Severe multi-impairment or diminished physical condition before stroke that could have caused paresis/spasticity/motor deficit per investigator judgement; * Life expectancy of less than 12 months as a result of severity of stroke or other illnesses (e.g. cardiac disease, malignancy, etc.) * Participation in any interventional study

Locations (20)

Loma Linda
Anderson, California, United States
University Of California, Los Angeles Medical Center
Los Angeles, California, United States
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
Florida City, Florida, United States
Knight Neurology
Rockledge, Florida, United States
Emory University Merge
Atlanta, Georgia, United States
Medstar Health Research Institute, Inc
Hyattsville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri Health Care
Columbia, Missouri, United States
Methodist Physicians Clinic
Omaha, Nebraska, United States
Madonna Rehabilitation Hospital - Omaha Campus
Omaha, Nebraska, United States
Duke University School of Medicine
Durham, North Carolina, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, United States
Moss Rehab
Elkins Park, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University Of Texas Southwestern Medical Center
Dallas, Texas, United States
McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location
Houston, Texas, United States
The University of Texas Health Science Center
San Antonio, Texas, United States
University Of Utah
Salt Lake City, Utah, United States