- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02536651
Reliability and Validity of the Finnish Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
August 14, 2017 updated by: Jussi Repo, Helsinki University Central Hospital
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
120
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have undergone surgery due to foot and ankle pathology
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 months to 10 years
|
|
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
|
2 months to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale Foot and Ankle questionnaire
Time Frame: 2 months to 10 years
|
The questionnaire assesses function of the ankle
|
2 months to 10 years
|
|
Lower Extremity Functional Scale questionnaire
Time Frame: 2 months to 10 years
|
The questionnaire assesses function of the ankle
|
2 months to 10 years
|
|
Kasari FIT (Function Intensity Time) index
Time Frame: 2 months to 10 years
|
The questionnaire assesses the physical function level
|
2 months to 10 years
|
|
The 15-Dimensions health-related quality of life instrument
Time Frame: 2 months to 10 years
|
The questionnaire assesses
|
2 months to 10 years
|
|
Visual Analogue Scales
Time Frame: 2 months to 10 years
|
The Visual Analogue Scales assessed pain
|
2 months to 10 years
|
|
Visual Analogue Scales
Time Frame: 2 months to 10 years
|
The Visual Analogue Scales assessed functional capabilities
|
2 months to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
August 23, 2015
First Submitted That Met QC Criteria
August 27, 2015
First Posted (Estimate)
September 1, 2015
Study Record Updates
Last Update Posted (Actual)
August 16, 2017
Last Update Submitted That Met QC Criteria
August 14, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 343/13/03/02/13/5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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