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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2022
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.


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.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Norway Oslo University Hospital, Department of Physical Medicine and Rehabilitation Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (6)

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

Outcome

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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