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

January 15, 2021 updated by: Jussi Repo, Helsinki University Central Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland
        • Central Finland Central Hospital
      • Oulu, Finland
        • Oulu University Hospital
      • Seinäjoki, Finland
        • Seinäjoki Central Hospital
      • Vantaa, Finland
        • Peijas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study recruits adult patients who are undergoing foot or ankle surgery for various reasons.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal important difference
Time Frame: Baseline, 6 months
Change from baseline scores at 6 months
Baseline, 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Oulu University Hospital
Seinajoki Central Hospital
Central Finland Hospital District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

March 6, 2019

Study Completion (Actual)

March 14, 2019

Study Registration Dates

First Submitted

January 13, 2018

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FA2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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