Translation & Psychometric Testing of the Norwegian Foot Functional Index

Status Completed

Clinical Trial Summary

The aim of this study is to translate into Norwegian and cross-culturally adapt the Foot Functional Index- revised, short form (FFI-RS) according to international guidelines. Furthermore, the reliability and the validity, responsiveness as well as floor and ceiling effect of the Norwegian version of the FFI-RS will be determined.

Clinical Trial Description

Foot Functional Index, revised short form is a foot specific patient reported outcome measurement (PROM) which covers pain, stiffness, activity limitations, disability as well as psychosocial issues. The aim of this study is to translate into Norwegian and cross-culturally adapt Foot Functional Index revised, short form (NFFI-RS). Furthermore, the reliability, validity, interpretability and responsiveness will be determined. The Department of Physical Medicine and Rehabilitation at Oslo University Hospital has an ongoing double blind, randomized sham-controlled trial (RCT) comparing the effect of radial extracorporeal shock wave therapy (rESWT), sham rESWT, standardized exercise program and usual care for patients with longstanding plantar fasciopathy (NCT03472989). The testing of the psychometric properties of the NFFI-RS will include totally hundred patients, both from the mentioned RCT as well as patients with other foot diagnosis recruited from our department. The translation of the original FFI-RS into Norwegian has been done following the official guidelines. In the test-retest study fifty patients will complete the NFFI-RS at a one week interval. Smallest detectable change, measurement error, floor and ceiling effects as well as internal consistency will be calculated by using the baseline data. To decide the construct validity we will test the various hypothesis at baseline. To calculate the responsiveness and the minimal clinically important change three months data will be assessed. Patient Global Impression of Change Scale will be used to assess the minimal clinically important change and responsiveness of the NFFI-RS with ROC and AUC analyses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04207164
Study type	Observational
Source	Oslo University Hospital
Contact
Status	Completed
Phase
Start date	March 23, 2018
Completion date	February 19, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Translation and Psychometric Testing of the Norwegian Foot Functional Index Revised, Short Version.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms