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CompletedNCT02536651Updated Aug 16, 2017

Reliability and Validity of the Finnish Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale

An observational study in Foot Diseases and Ankle Disease, sponsored by Helsinki University Central Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-16.

Sponsored by Helsinki University Central Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Foot Diseases
  • Ankle Disease

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Keywords

  • validation studies, patient-reported outcome measures
03

In context

Foot Diseases

55 studies on the registry are indexed under Foot Diseases; 11 are open to participants now.

This study's enrollment of 120 is close to the median of 120 across 13 observational studies indexed under Foot Diseases.

Browse Foot Diseases studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have undergone surgery due to foot and ankle pathology

Inclusion criteria

  • Pathology of the foot and ankle and
  • Surgery due to foot and ankle problems

Exclusion criteria

Exclusion Criteria:

  • Other than foot and ankle surgery
  • age under 18 years
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
120 participants (actual)
Patient registry
No

Interventions

  • ProcedureAnkle surgery

    Plastic or orthopedic surgery of the ankle

06

What researchers measure

Primary outcomes

  1. The validity of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale

    Assessment of the validity

    Time frame: 2 months to 10 years

  2. The reliability of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale

    Assessment of the test-retest reliability

    Time frame: 2 months to 10 years

Secondary outcomes

  1. Visual Analogue Scale Foot and Ankle questionnaire

    The questionnaire assesses function of the ankle

    Time frame: 2 months to 10 years

  2. Lower Extremity Functional Scale questionnaire

    The questionnaire assesses function of the ankle

    Time frame: 2 months to 10 years

  3. Kasari FIT (Function Intensity Time) index

    The questionnaire assesses the physical function level

    Time frame: 2 months to 10 years

  4. The 15-Dimensions health-related quality of life instrument

    The questionnaire assesses

    Time frame: 2 months to 10 years

  5. Visual Analogue Scales

    The Visual Analogue Scales assessed pain

    Time frame: 2 months to 10 years

  6. Visual Analogue Scales

    The Visual Analogue Scales assessed functional capabilities

    Time frame: 2 months to 10 years

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02536651
Lead sponsor
Helsinki University Central Hospital
Collaborators
Central Finland Hospital District
Responsible party
Jussi Repo (Researcher, Helsinki University Central Hospital) — Principal investigator
First posted
Sep 1, 2015
Start date
Sep 2014
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Aug 16, 2017

Study contacts

Erkki J Tukiainen, MD, PhD
study director · Helsinki University Hospital and University of Helsinki

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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