Foot DiseasesNCT04207164
Translation and Psychometric Testing of the Norwegian Foot Functional Index Revised, Short Version.
An observational study of Foot Diseases and Plantar Fascitis, run by Oslo University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Foot Diseases, Plantar Fascitis
- How many people
- 139 participants
- Where
- 1 siteNorway
- Study dates
- 23 Mar 2018to 19 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients with pain localized in the foot
- Patients understanding oral and written Norwegian
Who cannot join
- Patients without pain in the foot
- Patients not understanding oral and written Norwegian
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Department of Physical Medicine and Rehabilitation
Oslo, 0450
About this study
Official title: 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.
Read the 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.
- Conditions
- Foot Diseases, Plantar Fascitis
- Keywords
- Foot Functional Index revised,, Translation and cultural adaption, Reliability, Validity, Responsiveness
- Medical subject headings
- Foot Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week, 3 months
Secondary outcomes (3)
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.
Measured: Baseline
RAND-12
Health related quality of life (12 items). RAND-12 will be used for evaluating the construct validity of FFI-RS.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start23 Mar 2018
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Foot DiseasesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Mørk, Oslo University Hospital
- Investigators
- Aasne F Hoksrud, MD, PhD, Study director, Oslo University Hospital, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207164
- Sponsor's protocol ID
- 1045762
- Status last verified
- Apr 2022
- First submitted
- 1 Nov 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 2037861Budiman-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.
PubMed 16842719Hays 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.
PubMed 11491194Beaton 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.
PubMed 11124735Ferreira-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.
PubMed 21856077Terwee 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.
PubMed 17161752Mork 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.
PubMed 35505330
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-culture Adaption of Foot Functional Index Revised, Short Version (FFI-RS) Into Norwegian. Testing of Psychometric Properties.
- ClinicalTrials.gov ID
- NCT04207164
- Acronym / sponsor ID
- 1045762
- Conditions
- Foot Diseases, Plantar Fascitis
- Keywords
- Foot Functional Index revised,, Translation and cultural adaption, Reliability, Validity, Responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with pain localized in the foot
- Patients understanding oral and written Norwegian
Key exclusion criteria (2 listed)
- Patients without pain in the foot
- Patients not understanding oral and written Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Foot Functional Index revised short version ( FFI-RS)
Time frame: Baseline, 1 week, 3 months
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.
3 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: Baseline
RAND-12
Time frame: Baseline
Patient Global Impression Of Change Scale (PGIC)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Results publication: PubMed 2037861Budiman-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.
- Results publication: PubMed 16842719Budiman-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.
- Results publication: PubMed 11491194Hays 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.
- Results publication: PubMed 11124735Beaton 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.
- Results publication: PubMed 21856077Ferreira-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.
- Results publication: PubMed 17161752Terwee 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.
- Derived from this study: PubMed 35505330Mork 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aasne F Hoksrud, MD, PhD study director
Oslo University Hospital, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Diseases and Plantar Fascitis, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Functional Index revised short version ( FFI-RS) (time frame: Baseline, 1 week, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207164, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.