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NCT Number: NCT02536651

Reliability and Validity of the Finnish 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

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Key information

Conditions

Foot Diseases Ankle Disease Musculoskeletal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ankle surgery

Procedure

Plastic or orthopedic surgery of the ankle

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Visual Analogue Scale Foot and Ankle questionnaire

    Time frame: 2 months to 10 years

    The questionnaire assesses function of the ankle

  2. Lower Extremity Functional Scale questionnaire

    Time frame: 2 months to 10 years

    The questionnaire assesses function of the ankle

  3. Kasari FIT (Function Intensity Time) index

    Time frame: 2 months to 10 years

    The questionnaire assesses the physical function level

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

    Time frame: 2 months to 10 years

    The questionnaire assesses

  5. Visual Analogue Scales

    Time frame: 2 months to 10 years

    The Visual Analogue Scales assessed pain

  6. Visual Analogue Scales

    Time frame: 2 months to 10 years

    The Visual Analogue Scales assessed functional capabilities

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Central Finland Hospital District

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 1, 2015
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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