All studies
Active not recruitingOBSERVATIONAL

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

This study aims to understand how often muscle stiffness, called spasticity, affects people in the year after their first stroke. Stroke is a serious condition caused by a sudden interruption of blood flow to the brain. Spasticity can make muscles feel tight or rigid. Researchers will monitor participants to identify how many develop spasticity that could benefit from treatment. The findings of this study will help develop clear guidelines for healthcare professionals on the best way to watch for and identify spasticity early on, ensuring people receive timely support and care after a stroke.

At a glance

Status
Active not recruiting
Sponsor
Ipsen
Enrolment target
1,058
Start
01 Nov 2023
Estimated completion
30 Nov 2027

What is this study about?

This study is looking into a common problem called spasticity, which can happen after someone has a stroke. A stroke is a very serious event where the blood supply to part of the brain is suddenly cut off. This can lead to various difficulties, and one of these is spasticity, which makes muscles stiff or rigid.

The main goal of this research is to understand how many people who have had a stroke for the first time then go on to develop spasticity that would benefit from medication. The study will carefully follow these individuals for a year after their stroke. By doing this, the researchers hope to gather vital information about how often spasticity occurs and how it develops over time.

Ultimately, the results of this study are expected to help doctors and nurses by providing clear, standard guidelines on the best way to monitor people for spasticity after a stroke. This means that if you've had a stroke, healthcare professionals will have better tools to look out for spasticity and decide when treatment might be helpful, leading to better care and support for stroke survivors.

Key takeaways

  • The study looks at spasticity after a stroke.
  • It aims to find out how many stroke survivors get spasticity needing treatment.
  • Participants will be followed for one year.
  • Results will help doctors monitor spasticity better.
  • Participation contributes to improving future stroke care.

Who may be eligible?

To take part in this study, you must be between 18 and 90 years old. You should have had your very first stroke within the last four weeks, and this stroke must have caused some weakness in your arms or legs that didn't get better within a day. You also need to be able to understand the study and agree to participate.

You wouldn't be able to join if you had significant walking or movement problems before your stroke, or if you have another serious brain condition that affects your muscles. People with other severe health problems that might affect their physical condition or reduce their life expectancy to less than a year, including serious heart conditions or cancer, wouldn't be eligible. Also, if you're already involved in another medical study that involves receiving a treatment, you won't be able to participate in this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 90 years old?
  2. Did you have your first stroke within the last 4 weeks?
  3. Did your stroke cause weakness in your arm or leg that lasted more than a day?
  4. Do you have no significant movement problems before your stroke?
  5. Are you not currently involved in another medical trial with a new treatment?
Answer every question to see your result.

What does participation involve?

This study involves monitoring patients for a full year after their stroke. The exact details of how many visits or assessments are needed aren't specified, but the overall involvement is about observing you as you recover. There isn't information provided about specific medications or interventions you would receive as part of this study, as it primarily focuses on observation and understanding the development of spasticity. The study's total duration for each participant is one year.

Potential risks and benefits

Participating in this study may not offer direct personal benefits, as it focuses on observation rather than providing a new treatment. However, the information gathered will help future stroke survivors by improving how spasticity is identified and managed. The risks associated with this observational study are generally low, likely involving only the time and effort of attending appointments and providing information. You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (54)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Loma Linda
    Verified postcode
    Anderson, United States
  • Knight Neurology
    Verified postcode
    Rockledge, United States
  • Medstar Health Research Institute, Inc
    Verified postcode
    Hyattsville, United States
  • Massachusetts General Hospital
    Verified postcode
    Boston, United States
  • Spaulding Rehabilitation Hospital
    Verified postcode
    Boston, United States
  • University of Missouri Health Care
    Verified postcode
    Columbia, United States
  • Methodist Physicians Clinic
    Verified postcode
    Omaha, United States
  • Madonna Rehabilitation Hospital - Omaha Campus
    Verified postcode
    Omaha, United States
  • Duke University School of Medicine
    Verified postcode
    Durham, United States
  • Dayton Center for Neurological Disorders
    Verified postcode
    Centerville, United States
  • Moss Rehab
    Verified postcode
    Elkins Park, United States
  • Medical University of South Carolina
    Verified postcode
    Charleston, United States

Common questions

What is spasticity?

Spasticity is a condition that can happen after a stroke, causing your muscles to become stiff or tight.

What will I have to do in this study?

You will be monitored for a year after your stroke to see if you develop spasticity that could be helped by treatment.

Will I receive new medication in this study?

This study is focused on observation and understanding spasticity; it does not involve giving new medications as part of the research itself.

How long does the study last?

Each person involved in the study will be monitored for one year after their stroke.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and it will not affect your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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