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

Translation, Cross-culture Adaption of Foot Functional Index Revised, Short Version (FFI-RS) Into Norwegian. Testing of Psychometric Properties.

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.

Study Overview

• Status: Completed
• Conditions: Foot Diseases; Plantar Fascitis

Detailed 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 Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Oslo University Hospital, Department of Physical medicine and rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with foot pain attending the Department of Physical Medicine and Rehabilitation at Oslo University Hospital (OUS), Norway will be included. Some of the patients will have the diagnosis Plantar Fasciopathy (PF) and is a part of the ongoing RCT from the same department at OUS: "The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham rESWT, standardised exercised exercise programme or usual care for patients with plantar fasciopathy." (NCT03472989)(2017/1325 Regional Comimittee for Medical and Health Research Ethics,Norway).

Rest of the study population will be patients with othe foot complaints.

Description

Inclusion Criteria:

• Patients with pain localized in the foot
• Patients understanding oral and written Norwegian

Exclusion Criteria:

• Patients without pain in the foot
• Patients not understanding oral and written Norwegian

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Functional Index revised short version ( FFI-RS)	FFI-RS is a foot specific pain and function score. We will evaluate the reliability of the FFI-RS by testing the internal consistency (Cronbach's Alpha). Furthermore test-retest will be done with a second FFI-RS recording after one week (weighted Kappa). We will evaluate construct validity with other instruments (RAND-12 and NRS). To test the responsiveness of FFI-RS, we will evaluate the change in FFI-RS from baseline to 3 months with Patient Global Impression of Change score.	Baseline, 1 week, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS)	Change in heel pain (during Activity last week). NRS is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain). NRS will by used for evaluating the construct validity of FFI-RS.	Baseline
RAND-12	Health related quality of life (12 items). RAND-12 will be used for evaluating the construct validity of FFI-RS.	Baseline
Patient Global Impression Of Change Scale (PGIC)	7-point scale ranging from "very much improved" to "very much worse". PGIC will be used for evaluating the responsiveness of FFI-RS.	3 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Aasne F Hoksrud, MD, PhD, Oslo University Hospital, Department of Physical medicine and rehabilitation

Publications and helpful links

General Publications

• Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4.
• Budiman-Mak E, Conrad K, Stuck R, Matters M. Theoretical model and Rasch analysis to develop a revised Foot Function Index. Foot Ankle Int. 2006 Jul;27(7):519-27. doi: 10.1177/107110070602700707.
• Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089.
• Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
• Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
• Mork M, Hoksrud AF, Soberg HL, Zucknick M, Heide M, Groven KS, Roe C. "Psychometric properties of the Norwegian foot function index revised short form". BMC Musculoskelet Disord. 2022 May 3;23(1):416. doi: 10.1186/s12891-022-05374-x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2018
• Primary Completion (ACTUAL): February 19, 2021
• Study Completion (ACTUAL): February 19, 2021

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (ACTUAL): December 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Validity; Reliability; Responsiveness; Foot Functional Index revised,; Translation and cultural adaption
• Additional Relevant MeSH Terms: Skin Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar; Foot Diseases
• Other Study ID Numbers: 1045762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No