RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-01
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06055725

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be aged 18 to 85 years at the time of providing informed consent
  2. * 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;
  3. * 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
  4. * Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
  1. * Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale \>2);
  2. * Presence of significant/major neurological impairment that might affect muscle tone (other than limb paresis);
  3. * Severe multi-impairment or diminished physical condition before stroke that could have caused paresis/spasticity/motor deficit per investigator judgement;
  4. * Life expectancy of less than 12 months as a result of severity of stroke or other illnesses (e.g. cardiac disease, malignancy, etc.)
  5. * Participation in any interventional study

Contacts and Locations

Study Contact

Ipsen Clinical Study Enquiries
CONTACT
See e mail
clinical.trials@ipsen.com

Principal Investigator

Ipsen Medical Director
STUDY_DIRECTOR
Ipsen

Study Locations (Sites)

Loma Linda
Anderson, California, 92354
United States
University Of California, Los Angeles Medical Center
Los Angeles, California, 90095
United States
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
Florida City, Florida, 13330
United States
Emory University Merge
Atlanta, Georgia, 30329-2206
United States
Medstar Health Research Institute, Inc
Hyattsville, Maryland, 20782
United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
University of Missouri Health Care
Columbia, Missouri, 65212
United States
Methodist Physicians Clinic
Omaha, Nebraska, 68114
United States
Duke University School of Medicine
Durham, North Carolina, 27705
United States
Moss Rehab
Elkins Park, Pennsylvania, 19027
United States
The University Of Texas Southwestern Medical Center
Dallas, Texas, 75390-8869
United States
The University of Texas Health Science Center
San Antonio, Texas, 78229
United States
University Of Utah
Salt Lake City, Utah, 84112
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Ipsen

  • Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2027-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Spasticity as Sequela of Stroke