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Monitoring post-stroke spasticity occurrence and guidelines

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

Observational Ipsen · NCT06055725

This study is tracking people who have had their first stroke for a year to see how often they develop stiff muscles and to create guidelines for managing this condition.

Quick facts

Study typeObservational
Enrollment1051 (estimated)
Ages18 Years to 90 Years
SexAll
SponsorIpsen Industry-sponsored
Locations42 sites (Anderson, California and 41 other locations)
Trial IDNCT06055725 on ClinicalTrials.gov

What this trial studies

This observational study aims to monitor patients who have experienced their first-ever stroke over the course of one year. The primary goal is to estimate the frequency of post-stroke spasticity, a condition characterized by stiff or rigid muscles, and to develop standard guidelines for monitoring its development. Participants will be assessed for signs of spasticity and their ability to provide informed consent will be evaluated. The findings will help establish a framework for identifying and managing spasticity in stroke survivors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 who have had their first-ever stroke within the past four weeks and exhibit confirmed muscle weakness.

Not a fit: Patients with significant neurological impairments or functional impairments prior to the stroke may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for patients experiencing post-stroke spasticity.

How similar studies have performed: While there have been studies on post-stroke conditions, this specific approach to monitoring spasticity is novel and aims to establish standardized guidelines.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Anderson, California and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Spasticity as Sequela of Stroke
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.