Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02536651
Status:
COMPLETED
Last Update Posted:
2017-08-16
First Post:
2015-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity of the Finnish Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005534', 'term': 'Foot Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-14', 'studyFirstSubmitDate': '2015-08-23', 'studyFirstSubmitQcDate': '2015-08-27', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The validity of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale', 'timeFrame': '2 months to 10 years', 'description': 'Assessment of the validity'}, {'measure': 'The reliability of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale', 'timeFrame': '2 months to 10 years', 'description': 'Assessment of the test-retest reliability'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale Foot and Ankle questionnaire', 'timeFrame': '2 months to 10 years', 'description': 'The questionnaire assesses function of the ankle'}, {'measure': 'Lower Extremity Functional Scale questionnaire', 'timeFrame': '2 months to 10 years', 'description': 'The questionnaire assesses function of the ankle'}, {'measure': 'Kasari FIT (Function Intensity Time) index', 'timeFrame': '2 months to 10 years', 'description': 'The questionnaire assesses the physical function level'}, {'measure': 'The 15-Dimensions health-related quality of life instrument', 'timeFrame': '2 months to 10 years', 'description': 'The questionnaire assesses'}, {'measure': 'Visual Analogue Scales', 'timeFrame': '2 months to 10 years', 'description': 'The Visual Analogue Scales assessed pain'}, {'measure': 'Visual Analogue Scales', 'timeFrame': '2 months to 10 years', 'description': 'The Visual Analogue Scales assessed functional capabilities'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['validation studies, patient-reported outcome measures'], 'conditions': ['Foot Diseases', 'Ankle Disease']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have undergone surgery due to foot and ankle pathology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathology of the foot and ankle and\n* Surgery due to foot and ankle problems\n\nExclusion Criteria:\n\n* Other than foot and ankle surgery\n* age under 18 years'}, 'identificationModule': {'nctId': 'NCT02536651', 'briefTitle': 'Reliability and Validity of the Finnish Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Reliability and Validity of the Finnish Versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale', 'orgStudyIdInfo': {'id': '343/13/03/02/13/5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ankle surgery', 'type': 'PROCEDURE', 'description': 'Plastic or orthopedic surgery of the ankle'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Erkki J Tukiainen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Hospital and University of Helsinki'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Finland Hospital District', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Jussi Repo', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}