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

NCT04207164 | Completed

• 1 other identifier: 1045762
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foot Diseases; Plantar Fascitis

Keywords

Foot Functional Index revised,; Translation and cultural adaption; Reliability; Validity; Responsiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Numeric Rating Scale (NRS)

  Baseline

• RAND-12

  Baseline

• Patient Global Impression Of Change Scale (PGIC)

  3 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Department of Physical Medicine and Rehabilitation

Oslo, 0450, Norway

Location

Related Publications (7)

• 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.

  PMID: 2037861 RESULT

• 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.

  PMID: 16842719 RESULT

• 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.

  PMID: 11491194 RESULT

• 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.

  PMID: 11124735 RESULT

• 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.

  PMID: 21856077 RESULT

• 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.

  PMID: 17161752 RESULT

• 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.

  PMID: 35505330 DERIVED

MeSH Terms

Conditions

Foot Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aasne F Hoksrud, MD, PhD

  Oslo University Hospital, Department of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: December 20, 2019
• Study Start: March 23, 2018
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)