Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT03403218
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2017-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spanish Version of the Balance Evaluation Systems Test and Mini Balance Evaluation Systems Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-01-30', 'releaseDate': '2022-04-29'}, {'resetDate': '2025-01-23', 'releaseDate': '2024-12-21'}], 'estimatedResultsFirstSubmitDate': '2022-04-29'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D003953', 'term': 'Diagnosis-Related Groups'}], 'ancestors': [{'id': 'D011445', 'term': 'Prospective Payment System'}, {'id': 'D012051', 'term': 'Reimbursement Mechanisms'}, {'id': 'D007349', 'term': 'Insurance, Health, Reimbursement'}, {'id': 'D005381', 'term': 'Financing, Organized'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-23', 'size': 40128, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-09-23T06:29', 'hasProtocol': False}, {'date': '2017-09-23', 'size': 283017, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-09-23T06:38', 'hasProtocol': False}, {'date': '2018-01-09', 'size': 74537, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-01-09T15:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single group assignment. cross-sectional survey.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-17', 'studyFirstSubmitDate': '2017-09-23', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'concurrent validity of mini-BESTest', 'timeFrame': '1 month', 'description': 'concurrent validity of mini-BESTest compare to Berg scale and FES.'}], 'primaryOutcomes': [{'measure': 'Concurrent validity of Best test- 1', 'timeFrame': '1 month', 'description': 'concurrent validity of BESTest compare to other model balance tests'}], 'secondaryOutcomes': [{'measure': 'Psychometric properties of Spanish version of BESTest.', 'timeFrame': '1 year', 'description': 'To perform a detailed analysis of the psychometric properties of the BESTest Spanish version.'}, {'measure': 'Psychometric properties of Spanish version of mini-BESTest.', 'timeFrame': '1 year', 'description': 'To perform a detailed analysis of the psychometric properties of the mini-BESTest Spanish version.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['balance, risk of falling'], 'conditions': ['Balance']}, 'referencesModule': {'references': [{'pmid': '33148216', 'type': 'DERIVED', 'citation': 'Dominguez-Olivan P, Gasch-Gallen A, Aguas-Garcia E, Bengoetxea A. Validity and reliability testing of the Spanish version of the BESTest and mini-BESTest in healthy community-dwelling elderly. BMC Geriatr. 2020 Nov 4;20(1):444. doi: 10.1186/s12877-020-01724-3.'}]}, 'descriptionModule': {'briefSummary': 'This study aim to translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish population.', 'detailedDescription': 'To translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish. Check its metric properties in relation to other balance tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: healthy subjects without diagnosed balance problems.\n\n\\-\n\nExclusion Criteria:\n\n* Diagnosed balance problems.\n* One falling in the last three months.'}, 'identificationModule': {'nctId': 'NCT03403218', 'acronym': 'BESTest', 'briefTitle': 'Spanish Version of the Balance Evaluation Systems Test and Mini Balance Evaluation Systems Test', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Translation and Validation of the Spanish Version of the BESTest and Mini-BESTest', 'orgStudyIdInfo': {'id': 'PI17/0282'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'case group', 'description': 'BESTest, mini-BESTest, Berg scale and FES (falls efficacy scale) (in Spanish version is administrated in case group.', 'interventionNames': ['Behavioral: Case group']}], 'interventions': [{'name': 'Case group', 'type': 'BEHAVIORAL', 'description': 'assessment of quality on posture, transfers and displacement', 'armGroupLabels': ['case group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Facultad de Ciencias de la Salud', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Angel Mr Lanas-Arbeloa', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Investigacion Sanitaria de Aragon'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'data will become available from October 2017 and for three months.', 'ipdSharing': 'YES', 'description': 'Blind date analysis researcher. By coding affiliation information.', 'accessCriteria': 'affiliation date are code. The rest of registration is shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Aragones de Ciencias de la Salud', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD. Titular de Universidad.', 'investigatorFullName': 'Pilar Dominguez-Olivan', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-29', 'type': 'RELEASE'}, {'date': '2023-01-30', 'type': 'RESET'}, {'date': '2024-12-21', 'type': 'RELEASE'}, {'date': '2025-01-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Pilar Dominguez-Olivan, PhD. Titular de Universidad., Universidad de Zaragoza'}}}}