Loading clinical trials...

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

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

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

NCT06055725•Ipsen

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

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 (59)

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

Key Dates

Start Date

November 1, 2023

Primary Completion Date

November 30, 2027

Completion Date

November 30, 2027

Last Updated

March 4, 2026

Enrollment

1,051

ESTIMATED participants

Conditions

Spasticity as Sequela of Stroke

Contacts

Ipsen Clinical Study Enquiries

CONTACT

See e mail clinical.trials@ipsen.com

Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity

NCT06358976

Spasticity as Sequela of Stroke

View study

COMPLETEDPHASE2

Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections

NCT04502264

Chronic StrokeSpasticity as Sequela of Stroke+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity

Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections

H-reflex Measurement in Hemiplegic Stroke Patients

Motor Imagery Technique on Lower Limb Function Among Stroke Patients.

Prevalence of Postural Patterns of Upper Extremity.