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

NCT ID: NCT06878235

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-11

Study Completion Date

2026-06-30

Brief Summary

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This is a national, multicentric, prospective, descriptive study evaluating the psychometric properties of the French version PLSFRS scale

Detailed Description

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This is a prospective study conducted in 8 French ALS centers which will enroll 80 patients with PLS. All these patients will undergo an evaluation of their functional status from the ALSFRS-r and PLSFRS scales. All patients will be evaluated at 3 time points (T0,M6 at the outpatient clinic) and at M3 remotely. The aim of the study will be to validate a trans-cultural and psychometric version of the PLSFRS available for the French PLS population.

Conditions

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Lateral Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with a primary lateral sclerosis

Assessment of the functional status

Intervention Type OTHER

assessment of their functional status using the French version of the PLSFRS scale during a routine multidisciplinary assessment every 3-6 months for all patients with motor neurone disease, as recommended by the FILSLAN network

Interventions

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Assessment of the functional status

assessment of their functional status using the French version of the PLSFRS scale during a routine multidisciplinary assessment every 3-6 months for all patients with motor neurone disease, as recommended by the FILSLAN network

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with primary lateral sclerosis (PLS)
* Age over 18 years
* Informed consent signed
* Patients cared in a French ALS centre

Exclusion Criteria

* patients with no oral and written command of the French language
* Patients unable to answer a questionnaire
* Opposition to data processing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe CORCIA, PR

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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University hospital

Brest, , France

Site Status RECRUITING

University hospital

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

University hospital

Lille, , France

Site Status NOT_YET_RECRUITING

University hospital

Limoges, , France

Site Status NOT_YET_RECRUITING

University hospital

Lyon, , France

Site Status NOT_YET_RECRUITING

University Hospital

Nice, , France

Site Status NOT_YET_RECRUITING

University hospital

Tours, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Philippe CORCIA, Pr

Role: CONTACT

0247473724 ext. +33

Facility Contacts

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Steeve GENESTET, Dr

Role: primary

0298347309 ext. +33

Nathalie GUY, Dr

Role: primary

0473752043 ext. +33

Véronique DANEL, Dr

Role: primary

0320445962 ext. +33

Philippe COURATIER, Pr

Role: primary

0555056559 ext. +33

Emilien BERNARD, Dr

Role: primary

0472357218 ext. +33

Marie-Hélène SORIANI, Dr

Role: primary

Philippe CORCIA, Pr

Role: primary

0247473724 ext. +33

Other Identifiers

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DR240260-FRENPRILS

Identifier Type: -

Identifier Source: org_study_id

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