Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04700605
Status:
UNKNOWN
Last Update Posted:
2021-01-08
First Post:
2021-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-rater Reliability and Agreement Between Two Dual Task Tests; WBB and Gait Test.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-27', 'size': 1231611, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-05T10:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2021-01-04', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-rater reliability for the gait test and the WBB test.', 'timeFrame': 'Through study completion, app. 8 months.', 'description': 'Comparing the dual task costs for each test between test and retest. Assessments through intraclass correlation coefficient and reportings in accordance with Guidelines for Reporting Reliability and Agreement Studies (GRRAS).'}], 'secondaryOutcomes': [{'measure': 'Agreement between the gait test and the WBB test as dual task measurements.', 'timeFrame': 'Through study completion, app. 8 months.', 'description': 'Comparing the dual task costs between the gait test and the Wii Balance Board test. Data assessment through Bland Altman plots and reportings in accordance with Guidelines for Reporting Reliability and Agreement Studies (GRRAS).'}, {'measure': 'Descriptive data.', 'timeFrame': 'Through study completion, app. 8 months.', 'description': 'Qustionnairies consisting of Tilburg Frailty Indicator, Vulnerable Elders Survey 13, Short Falls Efficacy Scale, previous falls, medications and Orientations-Memory-Concentrations test. Data assessment through histograms and Shapiro Wilk tests and reported by means and standard deviations, medians and interquartile ranges, and numbers and percentages.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Balance; Distorted']}, 'descriptionModule': {'briefSummary': 'Agreement and intra-rater reliability between static balance test using Nintendo Wii Balance Board and gait test under dual-task conditions in community-dwelling older adults.', 'detailedDescription': 'Participants:\n\nInvestigators aim to recruit a minimum of 30 participants aged 65 years or above through convenience sampling at an senior activity centre in the Municipality of Aalborg. Participants inclusion critiria is age about 65, the ability to stand for 30 seconds unaided and the ability to walk 8 meters. Exclusion critiria is severe cognitive impairment (e.g., dementia).\n\nProcedure:\n\nEach participant will undergo two testdays separated by approximately two weeks. Both testdays have the same number and order of tests and are placed approximately the same time of the day. At the first testday descriptive information for each participant is collected.\n\nMeasuring device:\n\nThe Nintendo Wii Balance Board (Nintendo, Kyoto, Japan) is a small portable force plate measuring sway ellipse area and sway speed.\n\nAnalysis:\n\nWill include intra-rater reliability for each test and agreement between the two. Calculations of balance/gait costs will be made to unify the unit and to compare the two tests to each other. Results shown by intraclass correlation coeffients and Bland Altman plots.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Minimum 65 year-old community dwelling citizens at activity centers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum 65 years old.\n* Community dwelling\n\nExclusion Criteria:\n\n* Unable to stand unsupported for 30 seconds\n* Unable to walk 8 meters unsupported'}, 'identificationModule': {'nctId': 'NCT04700605', 'briefTitle': 'Intra-rater Reliability and Agreement Between Two Dual Task Tests; WBB and Gait Test.', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Intra-rater Reliability and Agreement Between Static Balance Test Using Nintendo Wii Balance Board and Gait Test Under Dual Task Conditions in Community-dwelling Older Adults.', 'orgStudyIdInfo': {'id': '2020-096'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dual task balance test', 'type': 'BEHAVIORAL', 'description': 'Participants will be conducting two dual task tests; an 8m gait test and a Wii Balance Board test with simultaneous various cognitive tests.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9310', 'city': 'Vodskov', 'state': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Elstrøm', 'role': 'CONTACT', 'email': 'qr-aeh@aalborg.dk', 'phone': '004599313298'}], 'facility': 'Liselund Aktivitets Center', 'geoPoint': {'lat': 57.10854, 'lon': 10.02215}}], 'centralContacts': [{'name': 'Eriksen, student', 'role': 'CONTACT', 'email': 'martin.eriksen@rn.dk', 'phone': '004522234454'}, {'name': 'Gade, MD', 'role': 'CONTACT', 'email': 'gustav.soerensen@rn.dk', 'phone': '004552505753'}], 'overallOfficials': [{'name': 'Martin Eriksen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical student', 'investigatorFullName': 'Martin Eriksen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}