Translation and Psychometric Testing of the Norwegian Foot Functional Index Revised, Short Version.
NCT ID: NCT04207164
Last Updated: 2022-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
139 participants
OBSERVATIONAL
2018-03-23
2021-02-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients understanding oral and written Norwegian
Exclusion Criteria
* Patients not understanding oral and written Norwegian
18 Years
100 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Marianne Mørk
Physical Therapist
Principal Investigators
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Aasne F Hoksrud, MD, PhD
Role: STUDY_DIRECTOR
Oslo University Hospital, Department of Physical Medicine and Rehabilitation
Locations
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Oslo University Hospital, Department of Physical Medicine and Rehabilitation
Oslo, , Norway
Countries
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References
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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.
Other Identifiers
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1045762
Identifier Type: -
Identifier Source: org_study_id
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