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New study aims to predict who gets muscle stiffness after stroke

NCT ID NCT06055725

Knowledge-focused Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study follows over 1,000 adults who had their first stroke to see how many develop spasticity—a condition where muscles become stiff or rigid—within the first year. Researchers will monitor participants and create a best-practice guide for doctors to spot and treat this common complication. The goal is to improve care and quality of life for stroke survivors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could establish a standard guideline for monitoring post-stroke spasticity, helping doctors identify patients who need treatment earlier.
What could go wrong
This is an observational study, not testing a new treatment. It may not change outcomes directly, and results might not apply to all stroke patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,057 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The Main Population will be participants aged 18 to 90 years with confirmed paresis within 2 weeks after a first-ever clinical stroke that has occurred within the past 4 weeks

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spasticity as sequela of stroke

Contacts and locations

Locations

  • AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno

    Salerno, 84131, Italy

  • AOU maggiore della Carita'

    Novara, 28100, Italy

  • Angelholm Northern Hospital

    Ängelholm, 26281, Sweden

  • Azienda Ospedaliero Universitaria OO RR di Foggia

    Foggia, 71100, Italy

  • CHU Bordeaux-Hopital Pellegrin

    Bordeaux, 33076, France

  • CHU Nantes

    Saint-Jacques, France

  • CHU de Caen

    Caen, 14033, France

  • CHU de Rennes, Hopital de Pontchaillou

    Rennes, 35033, France

  • Charité - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117, Germany

  • Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro

    Vigo, 36200, Spain

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459, United States

  • Duke University School of Medicine

    Durham, North Carolina, 27705, United States

  • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)

    Düsseldorf, Germany

  • Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle

    Saint-Genis-Laval, 69230, France

  • Hospital Clinic i Provincial

    Barcelona, Spain

  • Hospital Mutua De Terrassa

    Barcelona, 08221, Spain

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet de Zaragoza

    Zaragoza, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Karnsjukhuset Skaraborg

    Skövde, 54185, Sweden

  • Kings College Hospital NHS Foundation Trust

    London, United Kingdom

  • Klinikum Altenburger Land GmbH

    Altenburg, Germany

  • Knight Neurology

    Rockledge, Florida, 32955, United States

  • Las Vegas Neurology Center

    Las Vegas, Nevada, 89106, United States

  • Loma Linda

    Anderson, California, 92354, United States

  • Madonna Rehabilitation Hospital - Omaha Campus

    Omaha, Nebraska, 68118, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • McGovern Medical School - UT Physicians - Neurology (Adult Neurology Clinic) - Texas Medical Center Location

    Houston, Texas, 77030, United States

  • Medical College of Wisconsin

    Milwauke, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medstar Health Research Institute, Inc

    Hyattsville, Maryland, 20782, United States

  • Methodist Physicians Clinic

    Omaha, Nebraska, 68114, United States

  • Milan University, Humanitas Clinical Institute

    Milan, Italy

  • Moss Rehab

    Elkins Park, Pennsylvania, 19027, United States

  • Neurological Rehabilitation Unit- Policlinico Borgo Roma.

    Verona, 37134, Italy

  • Neuromotor And Cognitive Rehabilitation Research Centre; Dep. Of Neurological, Neuropsychological, Morphological And Movement Sciences; Univ. Of Verona - Neurological Rehabilitation Unit- Policlinico Borgo Roma

    Verona, Italy

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham, United Kingdom

  • Ospedal Valduce

    Lecco, 23845, Italy

  • Skane University Hospital

    Malmö, 20502, Sweden

  • Sodra Alvsborgs Sjukhus

    Borås, 50455, Sweden

  • South Tees Hospitals Foundation Nhs Trust

    Middlesbrough, United Kingdom

  • Spaulding Rehabilitation Hospital

    Boston, Massachusetts, 02129, United States

  • The University Of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8869, United States

  • The Walton Centre

    Liverpool, United Kingdom

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa

    Madrid, Spain

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck

    Lübeck, 23562, Germany

  • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel

    Kiel, 24105, Germany

  • Universitaetsklinikum Tuebingen (UKT)

    Tübingen, Germany

  • Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz

    Mainz, 55131, Germany

  • University Hospital Carl Gustav Carus

    Dresden, Germany

  • University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)

    Leicester, LE5 4PW, United Kingdom

  • University Of Utah

    Salt Lake City, Utah, 84112, United States

  • University of Missouri Health Care

    Columbia, Missouri, 65212, United States

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