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Estimation of the Minimal Important Difference and Validation of Foot and Ankle Instruments

Foot Diseases Clinical Trial

Official title:
Estimation of the Minimal Important Difference and Validation of Finnish Versions of Foot and Ankle Patient-reported Outcome Instruments

Clinical Trial Summary

The present study investigates the minimal important change and validity of foot and ankle measures.

Clinical Trial Description

Patients who are waiting for foot and ankle surgery are recruited from four large referral centers (Peijas Hospital, Seinäjoki Central Hospital, Central Finland Central Hospital, Oulu University Hospital). Participants fill in foot and ankle-specific, generic and sosiodemographic questionnaires on the day of surgery, 6 months after surgery, and 6 months 2 weeks after surgery. Both pen-and-paper and electronic options for completing the questionnaire set are provided. The data obtained from the Foot and ankle outcome score (FAOS), European foot and ankle society (EFAS) score, modified Lower extremity functional scale (LEFS), Visual analog scale foot and ankle (VAS-FA), Manchester Oxford foot and ankle (MOxFA) questionnaire, and the Foot and ankle ability measure (FAAM) are analyzed using the Rasch Measurement Theory and several other psychometric approaches to investigate minimal important change, reliability, responsiveness and validity of foot and ankle PRO instruments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03444441
Study type Observational
Source Helsinki University Central Hospital
Contact
Status Completed
Phase
Start date January 15, 2018
Completion date March 14, 2019
View Details
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