Active not recruitingOBSERVATIONAL

Validation of the French Version of the Primary Lateral Sclerosis Functioning Rating Scale (PLSFRS)

This study, taking place across eight hospitals in France, aims to check if a new questionnaire, called the PLSFR-S, is a good tool for understanding how Primary Lateral Sclerosis (PLS) affects people's daily lives. Currently, there's a different scale (ALSFRS-r) used, and this new one is specifically designed for PLS. Researchers want to make sure the French version of this new questionnaire accurately measures people's abilities and is easy to use for French patients with PLS. About 80 adult patients will take part. They will fill out questionnaires at three different times over six months to see how consistent and reliable the new one is. The goal is to have a validated and widely accepted tool to better assess PLS.

At a glance

Status

Active not recruiting

Sponsor

University Hospital, Tours

Enrolment target

Start

11 Apr 2025

Estimated completion

01 Jan 2027

Lateral Sclerosis

What is this study about?

This study is about a condition called Primary Lateral Sclerosis (PLS). This is a rare disease that gradually affects the nerve cells in your brain that control movement. It can make muscles weaker and stiffer over time, making everyday tasks like walking or talking more difficult.

Researchers are looking at a new questionnaire, or 'scale', which is a set of questions that helps doctors understand how PLS is affecting someone's daily life. This particular questionnaire is called the PLSFRS. This study is testing a French version of it to make sure it works well and gives accurate results for people with PLS in France. Think of it like a new way to measure something – the study wants to make sure the measuring tape is reliable and accurate.

By carefully checking this new questionnaire, the study hopes to give doctors a better tool to understand how PLS affects their patients. This could help them track the condition more precisely and understand how different treatments or care plans might be helping. Ultimately, having a good tool means better care and support for people living with PLS.

Key takeaways

Tests a new questionnaire for Primary Lateral Sclerosis (PLS).
Aims to improve how doctors understand PLS in daily life.
Participation involves filling out questionnaires over six months.
No new medication or medical procedures required.
Helps advance understanding and care for PLS patients.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over, and have been diagnosed with Primary Lateral Sclerosis (PLS). You must also be receiving care at a hospital in France that specialises in ALS, and be able to understand and sign a consent form, which explains everything about the study.

There are a few reasons why someone might not be able to join. If you don't speak or write French, or if for any reason you can't fill out a questionnaire, you wouldn't be able to take part. Also, if you don't agree for your information to be used for the study, then you wouldn't be able to participate.

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.

Do I have Primary Lateral Sclerosis (PLS)?
Am I 18 years old or older?
Am I a patient at a French ALS centre?
Can I understand and speak French fluently?
Am I able to complete questionnaires?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to complete some questionnaires. You'll do this three times over a six-month period. Twice, at the very beginning and at six months, you'll complete the questionnaires when you visit the outpatient clinic. There will also be one assessment at three months, which you can complete from home. You won't need to take any new medications as part of this study, as it's only about assessing your condition using questionnaires. The total time you'd be involved in the study is six months.

Potential risks and benefits

This study involves filling out questionnaires, so there are no direct medical risks. You might find completing the questionnaires a bit tiring or emotional, as they ask about your daily abilities. The main benefit is that you'll be helping researchers develop a better tool to understand and track PLS, which could help future patients. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (7)

University hospital
Verified postcode
Brest, France
University hospital
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Clermont-Ferrand, France
University hospital
Verified postcode
Lille, France
University hospital
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Limoges, France
University hospital
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Lyon, France
University Hospital
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Nice, France
University hospital
Verified postcode
Tours, France

Common questions

What is Primary Lateral Sclerosis (PLS)?

PLS is a rare disease that slowly causes muscle weakness and stiffness, making daily movements harder.

What is the PLSFRS questionnaire for?

It's a set of questions designed to help doctors understand how PLS is affecting a person's everyday life and abilities.

Will I have to take new medicine?

No, this study only involves answering questionnaires; you won't be given any new medications.

How long will I be involved in the study?

You will be involved for a total of six months, completing questionnaires at three different times.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time without any reason, and it won't affect your medical care.