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

Description

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.

Conditions

Spasticity as Sequela of Stroke

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Spasticity as Sequela of Stroke
Intervention / Treatment

-

Contacts and Locations

Anderson

Loma Linda, Anderson, California, United States, 92354

Los Angeles

University Of California, Los Angeles Medical Center, Los Angeles, California, United States, 90095

Florida City

University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare), Florida City, Florida, United States, 13330

Atlanta

Emory University Merge, Atlanta, Georgia, United States, 30329-2206

Hyattsville

Medstar Health Research Institute, Inc, Hyattsville, Maryland, United States, 20782

Boston

Spaulding Rehabilitation Hospital, Boston, Massachusetts, United States, 02129

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Columbia

University of Missouri Health Care, Columbia, Missouri, United States, 65212

Omaha

Methodist Physicians Clinic, Omaha, Nebraska, United States, 68114

Durham

Duke University School of Medicine, Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must be aged 18 to 85 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
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ipsen,

Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

2027-01-01