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

Completed

• Conditions: Foot Diseases; Ankle Disease

• Registration Number: NCT03444441
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-13
• Study Start: 2018-01-15
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-23
• Primary Completion: 2019-03-06
• Study Completion: 2019-03-14
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Full understanding of Finnish language
• Undergoing foot or ankle surgery
• At least 18 years old

Exclusion Criteria

• Unbalanced mental disorder such as schizophrenia or depression
• Age under 18
• Does not understand Finnish
• Undergoing operation other than foot or ankle

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Minimal important difference	Baseline, 6 months	Change from baseline scores at 6 months

Secondary Outcome Measures

Name	Time	Method
Validity	6 months	6 months scores
Reliability	6 months, 6.5 months	Change from 6 months scores at 6.5 months
General health question	6 months, 6.5 months	Change from baseline scores at 6 months
Global assessment scale	6 months	Change from baseline scores at 6 months

Trial Locations

Locations (4)

Oulu University Hospital; 🇫🇮 Oulu, Finland

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland

Peijas Hospital; 🇫🇮 Vantaa, Finland