NCT03444441

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 290 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed 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.

Conditions

• Foot Diseases
• Ankle Disease

Interventions

Type	Name	Description
PROCEDURE	Foot or ankle surgery	Surgery for foot or ankle

Timeline

• Start date: 2018-01-15
• Primary completion: 2019-03-06
• Completion: 2019-03-14
• First posted: 2018-02-23
• Last updated: 2021-01-19

Locations

4 sites across 1 country: Finland