Plantar Fascitis Clinical Trial
Official title:
Translation, Cross-culture Adaption of Foot Functional Index Revised, Short Version (FFI-RS) Into Norwegian. Testing of Psychometric Properties.
NCT number | NCT04207164 |
Other study ID # | 1045762 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 23, 2018 |
Est. completion date | February 19, 2021 |
Verified date | April 2022 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 139 |
Est. completion date | February 19, 2021 |
Est. primary completion date | February 19, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital, Department of Physical Medicine and Rehabilitation | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. Review. — View Citation
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. Epub 2006 Aug 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | RAND-12 | Health related quality of life (12 items). RAND-12 will be used for evaluating the construct validity of FFI-RS. | Baseline | |
Secondary | 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 |
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