Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
Study NCT ID:
NCT04392466
Status:
UNKNOWN
Last Update Posted:
2020-05-21
First Post:
2020-05-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Dual Task Gait Characteristics in Individuals With Amputation and Healty Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-20', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking speed', 'timeFrame': 'Two minutes', 'description': 'Distance per second'}, {'measure': 'Coefficient of variation', 'timeFrame': 'Two minutes', 'description': 'Stride length variability coefficient'}], 'secondaryOutcomes': [{'measure': 'Step length', 'timeFrame': 'Two minutes', 'description': 'Length of right and left steps in cm'}, {'measure': 'Time on each foot', 'timeFrame': 'Two minutes', 'description': 'The period on right foot and left foot'}, {'measure': 'Average step cycle', 'timeFrame': 'Two minutes', 'description': 'Yhe period of step cycle'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dual Task', 'Amputation', 'Gait']}, 'referencesModule': {'references': [{'pmid': '34741932', 'type': 'DERIVED', 'citation': 'Demirdel S, Erbahceci F, Yazicioglu G. The effects of cognitive versus motor concurrent task on gait in individuals with transtibial amputation, transfemoral amputation and in a healthy control group. Gait Posture. 2022 Jan;91:223-228. doi: 10.1016/j.gaitpost.2021.10.036. Epub 2021 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'In amputee, dual task has been found to cause a decrease in walking speed. However, there is no study of how gait characteristics are affected when the speed does not change. The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.', 'detailedDescription': 'Walking is a complex task in which sensory and cognitive systems must be involved. The lower extremity amputee may need to use cognitive resources to focus on walking, monitor and control the prosthetic movements. The need to use cognitive resources may be higher in those with more proximal level amputation, such as above-knee level. The role of cognition and concentration is revealed by a cognitive task performed with posture and gait control using the dual task method. The dual task paradigm provides information about the automation of the default processes that underpin good performance disclosure. This approach involves performing two tasks at the same time. Dual task is divided into primary task and secondary task. The performance of the primary task while performing a single task is recorded. If there is a drop in performance when the secondary task is added, this indicates that the primary task needs high attention.\n\nIn proximal amputations, with the lost of movement system structures, functional impairment increases. Amputation from the proximal level affects daily life activities and walking ability more. Above-knee amputees reported more functional difficulties in ambulatory ambulation than transtibial amputee.\n\nThe aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Transtibial amputees, Transfemoral amputees, Healty individuals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Using a transtibial or transfemoral prosthesis for at least 1 year,\n* Between the ages of 18-65,\n\nExclusion Criteria:\n\n* To be diagnosed as a neurological, orthopedic, cognitive disorder,\n* Having a condition other than amputation that may affect gait.\n* Having different permanent disabilities other than amputation,\n* Using walking aid,'}, 'identificationModule': {'nctId': 'NCT04392466', 'briefTitle': 'Comparison of Dual Task Gait Characteristics in Individuals With Amputation and Healty Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Comparison of Cognitive and Motor Dual Task Gait Characteristics in Individuals With Transtibial, Transfemoral Amputation and Healty Individuals', 'orgStudyIdInfo': {'id': 'GO 20/23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transtibial amputees', 'description': 'People who use transtibial prosthesis.', 'interventionNames': ['Other: walking on the treadmill']}, {'label': 'Transfemoral amputees', 'description': 'People who use transfemoral prosthesis.', 'interventionNames': ['Other: walking on the treadmill']}, {'label': 'Healty individuals', 'description': 'Healty individuals', 'interventionNames': ['Other: walking on the treadmill']}], 'interventions': [{'name': 'walking on the treadmill', 'type': 'OTHER', 'description': 'Participants will walk on the treadmill under single task, cognitive dual task and motor dual task conditions.', 'armGroupLabels': ['Healty individuals', 'Transfemoral amputees', 'Transtibial amputees']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Altındağ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'senem demirdel, PhD', 'role': 'CONTACT', 'email': 'fzt_sb@hotmail.com'}], 'facility': 'Hacettepeu', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Senem Demirdel, PhD', 'role': 'CONTACT', 'email': 'fzt_sb@hotmail.com', 'phone': '+905432168216'}, {'name': 'Senem Demirdel, PhD', 'role': 'CONTACT', 'email': 'sdemirdel@hacettepe.edu.tr', 'phone': '+903213051576', 'phoneExt': '138'}], 'overallOfficials': [{'name': 'Fatih Erbahçeci, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Pricipal Investigator', 'investigatorFullName': 'Senem Demirdel', 'investigatorAffiliation': 'Hacettepe University'}}}}