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Validation of the Foot Health Status Questionnaire in French Language

Psychometric Validation of the Foot Health Status Questionnaire in French Language

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06933953
Acronym
FHSQ-Fr
Enrollment
150
Registered
2025-04-18
Start date
2025-03-31
Completion date
2027-02-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Foot Problems

Keywords

Surveys and Questionnaires, FHSQ French translation, Health status, Foot, Validity, Reliability

Brief summary

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.

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.

Interventions

OTHERQuestionnaires

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

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Internal consistencyDay 0It 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.
Temporal stability of patients' questionnaire scores FHSQ-en V 1.02Day 0 and day 7It 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
Measurement errorDay 0To 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.

Countries

France

Contacts

CONTACTStéphanie MARDHEL
stephanie.mardhel@gmail.com0788586556
PRINCIPAL_INVESTIGATORDelphine GUYET

IFRES of Alençon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026