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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03444441

Enrollment

290

Registered

2018-02-23

Start date

2018-01-15

Completion date

2019-03-14

Last updated

2021-01-19

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

Conditions

Ankle Disease, Foot Diseases

Keywords

Foot, Ankle, Finnish, Validation, FAOS, EFAS, LEFS, FAAM, VAS-FA, MOxFA

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.

Interventions

PROCEDUREFoot or ankle surgery

Surgery for foot or ankle

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Minimal important difference	Baseline, 6 months	Change from baseline scores at 6 months

Secondary

Measure	Time frame	Description
Reliability	6 months, 6.5 months	Change from 6 months scores at 6.5 months
General health question	Baseline, 6 months	Change from baseline scores at 6 months
Global assessment scale	6 months	Change from baseline scores at 6 months
Validity	Baseline	Baseline scores

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026