Ankle Injuries and DisordersNCT03262324
The Aim of Study is Translate and Adapt the Visual Analog Scale Foot and Ankle (VAS-FA) Instrument Into Turkish and Psycho-metrically Test Its Reliability and Validity Among Patients Who Had Foot and Ankle Disorders or Surgery
An observational study of Ankle Injuries and Disorders and Foot Injuries and Disorders, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
Trial summary
There have previously been no validated a specific foot and ankle patient-reported outcome measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and adapted into Turkish language. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Injuries and Disorders, Foot Injuries and Disorders
- What is being tested?
- VAS-FA Turkish version
- How many people
- 69 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Sep 2020to 30 Aug 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants must be sedentary person from Turkey and receiving treatment intervention between study dates for ankle or foot disorders
Who may be able to join
- Age between 18 and 65
- Participants who have foot and ankle disorders
- Participants must have an orthopedic intervention last 3 months;
- Conservative intervention
- Surgery intervention
Who cannot join
- Age less than 18 or more than 65
- Positive medical history concerning the entire lower extremity,
- Diabetes mellitus
- Drug abuse
- Psychiatric diseases
- Rheumatoid arthritis
- Neurological diseases
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hasan kalyoncu üniversity
Gaziantep, 27144
İstanbul Haseki Training and Research Hospital
Istanbul
About this study
Official title: Reliability and Validity of the Turkish Version of the Visual Analogue Scale Foot and Ankle (VAS-FA)
There have previously been no validated a specific foot and ankle patient-reported outcome measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and adapted into Turkish language. Thereafter, 200 patients who had foot and ankle disorders or surgery will complete VAS-FA questionnaire set on two separate occasions. Analyses included testing of floor-ceiling effect, internal consistency, reproducibility, and validity.
- Being tested
- VAS-FA Turkish version
- Keywords
- Foot and Ankle, Disorders, Outcome Measure
- Medical subject headings
- Ankle Injuries, Disease, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAS-FA Turkish versionOther
Also called Foot Function Index, Short Form-36
Self-reported outcome questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS-FA Turkish version
The VAS-FA contains 20 questions for the patient with five possible answers. For each question a VAS-value from 0 to 100 points is possible. The total value for the entire score (all 20 questions answered) is therefore 0-2000 points. This total value is then divided by 20, resulting in a possible total score ranging from 0 to 100 points.
Measured: 1 week
Secondary outcomes (2)
Foot Function Index (FFI)
It is a self-administered index consisting of 23 items divided into three subscales. To obtain a subscale score, the item scores for subscales are totaled and then divided by the maximum total possible for all of the subscale items that the patient indicates is applicable. Therefore, subscale scores range from 0 to 100, with higher scores indicating greater impairment. A total foot function score is derived by calculating the average of the three subscale scores.
Measured: 1 week
Short Form-36 (SF-36)
Completion of the 36 items yielded an 8-subscale profile of patient functional health and well being, as well as empirically derived physical and mental health component summary (PCS and MCS) measures. The subscales are scored as percentages and the summary measures are scaled to provide a score out of 50%.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start30 Sep 2020
- Primary completion30 Mar 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ankle Injuries and DisordersStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Usgu, Hasan Kalyoncu University
- Investigators
- Serkan Usgu, PhD, Study director, Hasan Kalyoncu UniversityGünseli Usgu, Phd, Principal investigator, Hasan Kalyoncu UniversityCan Muslu, MD, Study chair, İstanbul Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262324
- Sponsor's protocol ID
- 2017-09
- Status last verified
- Mar 2022
- First submitted
- 24 Aug 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hunt KJ, Hurwit D. Use of patient-reported outcome measures in foot and ankle research. J Bone Joint Surg Am. 2013 Aug 21;95(16):e118(1-9). doi: 10.2106/JBJS.L.01476.
PubMed 23965711Angthong C, Chernchujit B, Suntharapa T, Harnroongroj T. Visual analogue scale foot and ankle: validity and reliability of Thai version of the new outcome score in subjective form. J Med Assoc Thai. 2011 Aug;94(8):952-7.
PubMed 21863677Richter, M., Zech, S., Geerling, J., Frink, M., Knobloch, K., & Krettek, C. (2006). A new foot and ankle outcome score: Questionnaire based, subjective, Visual-Analogue-Scale, validated and computerized. Foot and ankle surgery, 12(4), 191-199.
Nair AV, Shamsuddin K, John PS, Hamalainen JA, Kurien MA. Correlation of visual analogue scale foot and ankle (VAS-FA) to AOFAS score in malleolar fractures using Indian language questionnare. Foot Ankle Surg. 2015 Jun;21(2):125-31. doi: 10.1016/j.fas.2014.10.006. Epub 2014 Dec 12.
PubMed 25937413Stuber J, Zech S, Bay R, Qazzaz A, Richter M. Normative data of the Visual Analogue Scale Foot and Ankle (VAS FA) for pathological conditions. Foot Ankle Surg. 2011 Sep;17(3):166-72. doi: 10.1016/j.fas.2010.05.005. Epub 2010 Jun 2.
PubMed 21783078Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
PubMed 10201543Lin CW, Moseley AM, Refshauge KM, Bundy AC. The lower extremity functional scale has good clinimetric properties in people with ankle fracture. Phys Ther. 2009 Jun;89(6):580-8. doi: 10.2522/ptj.20080290. Epub 2009 May 7.
PubMed 19423644Button G, Pinney S. A meta-analysis of outcome rating scales in foot and ankle surgery: is there a valid, reliable, and responsive system? Foot Ankle Int. 2004 Aug;25(8):521-5. doi: 10.1177/107110070402500802.
PubMed 15363371Goldstein CL, Schemitsch E, Bhandari M, Mathew G, Petrisor BA. Comparison of different outcome instruments following foot and ankle trauma. Foot Ankle Int. 2010 Dec;31(12):1075-80. doi: 10.3113/FAI.2010.1075.
PubMed 21189208Repo JP, Tukiainen EJ, Roine RP, Kautiainen H, Lindahl J, Ilves O, Jarvenpaa S, Hakkinen A. Reliability and validity of the Finnish version of the Visual Analogue Scale Foot and Ankle (VAS-FA). Foot Ankle Surg. 2018 Dec;24(6):474-480. doi: 10.1016/j.fas.2017.05.009. Epub 2017 Jun 7.
PubMed 29409192
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Visual Analogue Scale Foot and Ankle (VAS-FA)
- ClinicalTrials.gov ID
- NCT03262324
- Acronym / sponsor ID
- 2017-09
- Keywords
- Foot and Ankle, Disorders, Outcome Measure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 25 Aug 2017 (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.
There have previously been no validated a specific foot and ankle patient-reported outcome measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and adapted into Turkish language. Thereafter, 200 patients who had foot and ankle disorders or surgery will complete VAS-FA questionnaire set on two separate occasions. Analyses included testing of floor-ceiling effect, internal consistency, reproducibility, and validity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants must be sedentary person from Turkey and receiving treatment intervention between study dates for ankle or foot disorders
Key inclusion criteria (5 listed)
- Age between 18 and 65
- Participants who have foot and ankle disorders
- Participants must have an orthopedic intervention last 3 months;
Key exclusion criteria (7 listed)
- Age less than 18 or more than 65
- Positive medical history concerning the entire lower extremity,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAS-FA Turkish versionAlso: Foot Function Index, Short Form-36Self-reported outcome questionnaires | Other | – |
Primary outcome
VAS-FA Turkish version
Time frame: 1 week
The VAS-FA contains 20 questions for the patient with five possible answers. For each question a VAS-value from 0 to 100 points is possible. The total value for the entire score (all 20 questions answered) is therefore 0-2000 points. This total value is then divided by 20, resulting in a possible total score ranging from 0 to 100 points.
2 secondary outcomes
Foot Function Index (FFI)
Time frame: 1 week
Short Form-36 (SF-36)
Time frame: 1 week
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 31 Mar 2022.
- Results publication: PubMed 23965711Hunt KJ, Hurwit D. Use of patient-reported outcome measures in foot and ankle research. J Bone Joint Surg Am. 2013 Aug 21;95(16):e118(1-9). doi: 10.2106/JBJS.L.01476.
- Results publication: PubMed 21863677Angthong C, Chernchujit B, Suntharapa T, Harnroongroj T. Visual analogue scale foot and ankle: validity and reliability of Thai version of the new outcome score in subjective form. J Med Assoc Thai. 2011 Aug;94(8):952-7.
- Results publicationRichter, M., Zech, S., Geerling, J., Frink, M., Knobloch, K., & Krettek, C. (2006). A new foot and ankle outcome score: Questionnaire based, subjective, Visual-Analogue-Scale, validated and computerized. Foot and ankle surgery, 12(4), 191-199.
- Results publication: PubMed 25937413Nair AV, Shamsuddin K, John PS, Hamalainen JA, Kurien MA. Correlation of visual analogue scale foot and ankle (VAS-FA) to AOFAS score in malleolar fractures using Indian language questionnare. Foot Ankle Surg. 2015 Jun;21(2):125-31. doi: 10.1016/j.fas.2014.10.006. Epub 2014 Dec 12.
- Results publication: PubMed 21783078Stuber J, Zech S, Bay R, Qazzaz A, Richter M. Normative data of the Visual Analogue Scale Foot and Ankle (VAS FA) for pathological conditions. Foot Ankle Surg. 2011 Sep;17(3):166-72. doi: 10.1016/j.fas.2010.05.005. Epub 2010 Jun 2.
- Results publication: PubMed 10201543Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Results publication: PubMed 19423644Lin CW, Moseley AM, Refshauge KM, Bundy AC. The lower extremity functional scale has good clinimetric properties in people with ankle fracture. Phys Ther. 2009 Jun;89(6):580-8. doi: 10.2522/ptj.20080290. Epub 2009 May 7.
- Results publication: PubMed 15363371Button G, Pinney S. A meta-analysis of outcome rating scales in foot and ankle surgery: is there a valid, reliable, and responsive system? Foot Ankle Int. 2004 Aug;25(8):521-5. doi: 10.1177/107110070402500802.
- Results publication: PubMed 21189208Goldstein CL, Schemitsch E, Bhandari M, Mathew G, Petrisor BA. Comparison of different outcome instruments following foot and ankle trauma. Foot Ankle Int. 2010 Dec;31(12):1075-80. doi: 10.3113/FAI.2010.1075.
- Results publication: PubMed 29409192Repo JP, Tukiainen EJ, Roine RP, Kautiainen H, Lindahl J, Ilves O, Jarvenpaa S, Hakkinen A. Reliability and validity of the Finnish version of the Visual Analogue Scale Foot and Ankle (VAS-FA). Foot Ankle Surg. 2018 Dec;24(6):474-480. doi: 10.1016/j.fas.2017.05.009. Epub 2017 Jun 7.
- Individual participant dataSharing planned: Undecided
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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.
Serkan Usgu, PhD study director
Hasan Kalyoncu University
Günseli Usgu, Phd principal investigator
Hasan Kalyoncu University
Can Muslu, MD study chair
İstanbul Haseki Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries and Disorders and Foot Injuries and Disorders, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
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 5 inclusion and 7 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
VAS-FA Turkish version (time frame: 1 week). 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 NCT03262324, which also lists 10 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 31 Mar 2022.