Foot DiseasesNCT02536651
Reliability and Validity of the Finnish Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
An observational study of Foot Diseases and Ankle Disease, run by Helsinki University Central Hospital.
Trial summary
There are no validated patient-reported outcome measures to assess lower extremity function in Finnish language. The present study aimed to 1)translate and culturally validate the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale, and 2) study the psychometric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Diseases, Ankle Disease
- What is being tested?
- Ankle surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone surgery due to foot and ankle pathology
Who may be able to join
- Pathology of the foot and ankle and
- Surgery due to foot and ankle problems
Who cannot join
- Other than foot and ankle surgery
- age under 18 years
About this study
Official title: Reliability and Validity of the Finnish Versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
There are no validated patient-reported outcome measures to assess lower extremity function in Finnish language. The present study aimed to 1)translate and culturally validate the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale, and 2) study the psychometric properties of these two questionnaires
Read the detailed description
This study assesses the reliability and validity of the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale. The English versions were translated and trans-culturally adapted into Finnish language according to well accepted international translation guidelines. The psychometric properties are assessed by internal validity, intraclass correlation coefficient and test-retest reliability.
- Conditions
- Foot Diseases, Ankle Disease
- Being tested
- Ankle surgery
- Keywords
- validation studies, patient-reported outcome measures
- Medical subject headings
- Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle surgeryProcedure or surgery
Plastic or orthopedic surgery of the ankle
What is being measured
The primary outcome is the main question the study is designed to answer.
The validity of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
Assessment of the validity
Measured: 2 months to 10 years
The reliability of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
Assessment of the test-retest reliability
Measured: 2 months to 10 years
Secondary outcomes (6)
Visual Analogue Scale Foot and Ankle questionnaire
The questionnaire assesses function of the ankle
Measured: 2 months to 10 years
Lower Extremity Functional Scale questionnaire
The questionnaire assesses function of the ankle
Measured: 2 months to 10 years
Kasari FIT (Function Intensity Time) index
The questionnaire assesses the physical function level
Measured: 2 months to 10 years
The 15-Dimensions health-related quality of life instrument
The questionnaire assesses
Measured: 2 months to 10 years
Visual Analogue Scales
The Visual Analogue Scales assessed pain
Measured: 2 months to 10 years
Visual Analogue Scales
The Visual Analogue Scales assessed functional capabilities
Measured: 2 months to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DiseasesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Finland Hospital District
- Responsible party
- Principal investigator, Jussi Repo, Helsinki University Central Hospital
- Investigators
- Erkki J Tukiainen, MD, PhD, Study director, Helsinki University Hospital and University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536651
- Sponsor's protocol ID
- 343/13/03/02/13/5
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2015
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Finnish Versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
- ClinicalTrials.gov ID
- NCT02536651
- Acronym / sponsor ID
- 343/13/03/02/13/5
- Conditions
- Foot Diseases, Ankle Disease
- Keywords
- validation studies, patient-reported outcome measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Central Finland Hospital District
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Sep 2015 (estimated)
- 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 are no validated patient-reported outcome measures to assess lower extremity function in Finnish language. The present study aimed to 1)translate and culturally validate the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale, and 2) study the psychometric properties of these two questionnaires
Detailed description
This study assesses the reliability and validity of the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale. The English versions were translated and trans-culturally adapted into Finnish language according to well accepted international translation guidelines. The psychometric properties are assessed by internal validity, intraclass correlation coefficient and test-retest reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone surgery due to foot and ankle pathology
Key inclusion criteria (2 listed)
- Pathology of the foot and ankle and
- Surgery due to foot and ankle problems
Key exclusion criteria (2 listed)
- Other than foot and ankle surgery
- age under 18 years
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 |
|---|---|---|
| Ankle surgeryPlastic or orthopedic surgery of the ankle | Procedure or surgery | – |
Primary outcome
The validity of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
Time frame: 2 months to 10 years
Assessment of the validity
The reliability of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
Time frame: 2 months to 10 years
Assessment of the test-retest reliability
6 secondary outcomes
Visual Analogue Scale Foot and Ankle questionnaire
Time frame: 2 months to 10 years
Lower Extremity Functional Scale questionnaire
Time frame: 2 months to 10 years
Kasari FIT (Function Intensity Time) index
Time frame: 2 months to 10 years
The 15-Dimensions health-related quality of life instrument
Time frame: 2 months to 10 years
Visual Analogue Scales
Time frame: 2 months to 10 years
Visual Analogue Scales
Time frame: 2 months to 10 years
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 16 Aug 2017.
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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.
Erkki J Tukiainen, MD, PhD study director
Helsinki University Hospital and University of Helsinki
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Diseases and Ankle Disease, run by Helsinki University Central Hospital.
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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The validity of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale (time frame: 2 months to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2017.