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NCT02536651 Clinical Trial

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

Foot Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02536651
Other study ID # 343/13/03/02/13/5
Secondary ID
Status Completed
Phase N/A
First received August 23, 2015
Last updated August 14, 2017
Start date September 2014
Est. completion date August 2015

Study information
Verified date August 2017
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 properties of these two questionnaires

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ankle surgery
Plastic or orthopedic surgery of the ankle

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Helsinki University Central Hospital Central Finland Hospital District

Outcome
Type Measure Description Time frame Safety issue
Primary The validity of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale Assessment of the validity 2 months to 10 years
Primary The reliability of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale Assessment of the test-retest reliability 2 months to 10 years
Secondary Visual Analogue Scale Foot and Ankle questionnaire The questionnaire assesses function of the ankle 2 months to 10 years
Secondary Lower Extremity Functional Scale questionnaire The questionnaire assesses function of the ankle 2 months to 10 years
Secondary Kasari FIT (Function Intensity Time) index The questionnaire assesses the physical function level 2 months to 10 years
Secondary The 15-Dimensions health-related quality of life instrument The questionnaire assesses 2 months to 10 years
Secondary Visual Analogue Scales The Visual Analogue Scales assessed pain 2 months to 10 years
Secondary Visual Analogue Scales The Visual Analogue Scales assessed functional capabilities 2 months to 10 years
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