Ifres Ecole de Pedicure Podologie
Alençon, France
Location status: Recruiting
Recruiting
NCT Number: NCT06933953
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients coming to IFRES in Alençon (61) France for a pedicure or podiatry appointment,
- Age >= 18
- knowing how to speak, read and write French.
Exclusion criteria
- Have already taking part in this research before the proposition to get in.
Treatment and study plan
questionnaires
OtherPatients 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
Primary outcomes
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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.
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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
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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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Régional d'Orléans
Other
Registry information
Official study title
Psychometric Validation of the Foot Health Status Questionnaire in French Language
Acronym: FHSQ-Fr
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 18, 2025
- Registry last updated
- Apr 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.