Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-26 @ 6:15 AM
Study NCT ID:
NCT05054192
Status:
UNKNOWN
Last Update Posted:
2021-09-23
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity of Modified Four Square Step Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic Balance', 'timeFrame': '6 minutes', 'description': 'Dynamic balance is the ability of an object to balance while in motion or switching between positions. Dynamic balance will be evaluated with the modified four square step test. The duration as second will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Dynamic Balance', 'timeFrame': '4 minutes', 'description': 'Dynamic balance will be evaluated with the timed and go test and the test completion time will be recorded in seconds.'}, {'measure': 'Dynamic Balance', 'timeFrame': '25 minutes', 'description': 'Dynamic balance will be evaluated with the Berg Balance Test. The scores from the test will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postural Balance', 'Total Hip Arthroplasty', 'Falling'], 'conditions': ['Total Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Functional improvements are reached in patients with primary total hip arthroplasty compared to the pre-operative term however some problems as continued range of motion limitations, loss of joint proprioception sensation, and resulting balance and gait disorders may result in failure of the Four Square Step Test. Therefore, the need for the apply of the Modified Four Square Step Test in individuals with primary THA is necessary. The aim of this study is to evaluate the test-retest reliability, concurrent validity and minimal detectable change of the Modified Four Square Step Test in individuals with primary total hip arthroplasty.', 'detailedDescription': 'Roos et al. improved the Modified Four-Square Step Test to complete the test by stroke patients and not to fall due to practices of the test while performing the test. The Modified Four Square Step Test variates from the The Four Square Step Test is that the person is not asked to look ahead during the test, and instead of using a cane, tapes are used to prevent people from losing their balance by tripping over the obstacle. Thus, although the height of the obstacle is reduced, the boundaries of the obstacle are preserved.\n\nFunctional improvements are reached in patients with primary total hip arthroplasty compared to the pre-operative term however some problems as continued range of motion limitations, loss of joint proprioception sensation, and resulting balance and gait disorders may result in failure of the Four Square Step Test. Therefore, the need for the apply of the Modified Four Square Step Test in individuals with primary THA is necessary. The aim of this study is to evaluate the test-retest reliability, concurrent validity and minimal detectable change of the Modified Four Square Step Test in individuals with primary total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this study, the participants will consist of individuals who have previously undergone primary total hip arthroplasty in Afyonkarahisar Health Sciences University Health Practice and Research Center Orthopedics and Traumatology Polyclinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 18-85.\n* Having undergone primary total hip arthroplasty at least ≥6 months ago.\n\nExclusion Criteria:\n\n* Having severe cardiovascular or lung disease\n* Having severe dementia or communication difficulties\n* Having a musculoskeletal or neurological problem that may affect participation in balance tests\n* Having an uncorrectable visual impairment\n* Having a body mass index of more than 40 kg/m2'}, 'identificationModule': {'nctId': 'NCT05054192', 'briefTitle': 'Reliability and Validity of Modified Four Square Step Test', 'organization': {'class': 'OTHER', 'fullName': 'Afyonkarahisar Health Sciences University'}, 'officialTitle': 'Evaluation of Test-retest Reliability, Concurrent Validity and Minimal Detectable Change of the Modified Four Square Step Test in Individuals With Primary Total Hip Arthroplasty.', 'orgStudyIdInfo': {'id': '2021/414'}}, 'contactsLocationsModule': {'locations': [{'zip': '03030', 'city': 'Afyonkarahisar', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'EMEL TAŞVURAN HORATA, PhD', 'role': 'CONTACT', 'email': 'ethorata@gmail.com', 'phone': '+905547759663'}, {'name': 'EMEL TAŞVURAN HORATA, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'FATMA EKEN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'MURAT YEŞİL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'ÖZAL ÖZCAN, Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Afyonkarahisar Health Science University', 'geoPoint': {'lat': 38.75667, 'lon': 30.54333}}], 'centralContacts': [{'name': 'EMEL TAŞVURAN HORATA, PhD', 'role': 'CONTACT', 'email': 'ethorata@gmail.com', 'phone': '+905547759663'}], 'overallOfficials': [{'name': 'EMEL TAŞVURAN HORATA, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Afyonkarahisar Health Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Afyonkarahisar Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD; Assistant Professor', 'investigatorFullName': 'Emel Taşvuran Horata', 'investigatorAffiliation': 'Afyonkarahisar Health Sciences University'}}}}