Validation of the Foot Health Status Questionnaire in French Language (FHSQ-Fr)

April 29, 2026 updated by: Centre Hospitalier Régional d'Orléans

Psychometric Validation of the Foot Health Status Questionnaire in French Language

A French foot health survey showed that 73% of people examined felt pain and 38% don't left their home, which suggest a reduction in their life's quality and autonomy. Developed by Paul Bennett, FHSQ is a foot health-specific self administrated questionnaire. It sensitively detects changes in patients' foot health status, whatever their pathology, across multidimensional concepts of their quality of life. Actually, more than 150 scientific publications have cited it. Reliable and valid, it has already been translated and validated in multiple languages, but not in French. The subject of this study is to validate the translated and cross-cultural adapted French version FHSQ-fr through its psychometric results of validity and reliability. The study follows a 2-stage methodology.

The first, already completed, consisted of (back)translating the Australian FHSQ questionnaire into French by a scientific committee in order to obtain a pre-final version.

The second is to validate this final version using appropriate statistical analysis, including correlations studies with other French validated questionnaires, to determine its psychometric characteristics.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To assess validity, 150 volunteers will fill out French validated questionnaires, Foot Function Index (FFI), EuroQuality of life 5D-5L (EQ5D) , Visual Analogic Pain Scale (VAPS), and Short Form 12 Health survey (SF12). They will be evaluated about their pain, morphology, function and posture of their feet as usual at a podiatric school. To assess reliability, 50 respondents from the 150 who didn't receive any treatment after 7 to 10 days, will complete the FHSQ-fr again. It would improve knowledge of the status of foot health and its related quality of life in the general population and those suffering from specific pathologies such as diabetes or rheumatoid arthritis, the effectiveness of certain treatments on the same foot condition, and their evolutions using longitudinal studies in France. At the international, the French future results of studies using this clinimetric tool could be compared with those who come from other countries, and integrated to the Australian author's " Bigdataset" which compares, analyses and predicts more accurately the clinically significant efficacy of a treatment.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Alençon, France
        • Recruiting
        • Ifres Ecole de Pedicure Podologie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients coming to IFRES in Alençon (61) France for a pedicure or podiatry appointment,
  2. Age >= 18
  3. knowing how to speak, read and write French.

Exclusion Criteria:

1. Have already taking part in this research before the proposition to get in.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with foot problems
Patients will complete many questionnaires : FHSQ-fr, Foot Function Index, EQ-5D-5L, Visual Analog Pain Scale, SF-12
Other: Questionnaires

Patients will complete various questionnaires at J0: FHSQ-Fr, EQ-5D-5L, Foot Function Index, Visual analog pain scale, SF-12.

Patients who needs to come back for a visit at Day 7 (+ 3 days) will complete the FHSQ-Fr questionnaire for a second time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal consistency
Time Frame: Day 0
It is evaluated using Cronbach's alpha coefficient "α", which measures the internal consistency of a set of items, scales or sub-scales for a single clinical dimension. The value of this index is less than or equal to 1, and the closer alpha is to 1, the stronger it is. α" > 0.7 or >0.8 is considered fairly high. However, the coefficient must not be too close to 1, otherwise the items are redundant and duplicate each other.
Day 0
Temporal stability of patients' questionnaire scores FHSQ-en V 1.02
Time Frame: Day 0 and day 7

It is measured by the Intraclass Correlation Coefficient (ICC) and its 95% confidence interval, and/or the Pearson Correlation Coefficient.

By convention, fidelity is said to be:

  • Very good if ICC ≥0 91
  • Good if 0.9 ≤ ICC ≤ 0.71
  • Moderate if 0.70 ≤ ICC ≤ 0.51
  • Poor if 0.5 ≤ ICC ≤ 0.31
  • Very poor or nil if ICC ≤ 0.3
Day 0 and day 7
Measurement error
Time Frame: Day 0
To apply the criterion of good measurement error, the MIC (Minimal Important Change), the SDC (Smallest Detectable Change) or the LoA (Limits of Agreement) load will be calculated using a longitudinal approach based on anchoring.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Delphine GUYET, IFRES of Alençon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUO-2024-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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