Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 6:25 PM
Study NCT ID:
NCT05373160
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2022-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reference Values of Different Functional Tests With or Without Cognitive Dual-task in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}], 'ancestors': [{'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go Test without dual task', 'timeFrame': 'Baseline', 'description': 'The test measures the time (in seconds) will taken by a participant to stand up from a chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. To perform the test, the participants will sit on a chair, placing his/her back against the backrest and resting his/her arms on armrests. On the instruction "Go", the participants will rise up from a chair, walk to a line/block on the floor 3 m away, turn around, return, and sit back on a chair.'}, {'measure': '4 Meter Gait Speed Test without dual task', 'timeFrame': 'Baseline', 'description': 'The participant will walk briskly through the 1-meter "test" zone for acceleration, the central 4-meter "test" zone, and the 1-meter deceleration zone. Time starts with the first leg after the 0 meter line and time is stopped with the first leg after the 4 meter line. In this test, the result is recorded in meters per second (m/s).'}, {'measure': '10 Meter Walk Test without dual task', 'timeFrame': 'Baseline', 'description': "In this test, the participant will walk at the best possible speed in a pre-measured 10-meter area. The time starts when the participant's foot is on the starting line and ends when they cross the finish line. In this test, the result is recorded in total seconds."}, {'measure': 'Timed 25-Foot Walk Test without dual task', 'timeFrame': 'Baseline', 'description': 'The participant walks the distance of 7.62 meters as fast as possible but without running. The time to complete the distance will recorded in seconds.'}, {'measure': '1 min-Sit-to-Stand Test without dual task', 'timeFrame': 'Baseline', 'description': 'Participants put their hands on their hips and they had to stand up and sit down completely and as many times as possible from a chair (height = 46 cm) without arm rests during one minute. Participants are not allowed to use their arms as support. The number of sit-ups performed during 1 minute will recorded.'}, {'measure': 'Timed Up and Go Test with dual task', 'timeFrame': 'Baseline', 'description': 'The test measures the time (in seconds) will taken by a participant to stand up from a chair, walk a distance of 3 m, turn, walk back to the chair, and sit down. To perform the test, the participants will sit on a chair, placing his/her back against the backrest and resting his/her arms on armrests. On the instruction "Go", the participants will rise up from a chair, walk to a line/block on the floor 3 m away, turn around, return, and sit back on a chair. The participants will perform with dual task. This dual task will be to say the names of animals.'}, {'measure': '4 Meter Gait Speed Test with dual task', 'timeFrame': 'Baseline', 'description': 'The participant will walk briskly through the 1-meter "test" zone for acceleration, the central 4-meter "test" zone, and the 1-meter deceleration zone. Time starts with the first leg after the 0 meter line and time is stopped with the first leg after the 4 meter line. In this test, the result is recorded in meters per second (m/s). The participants will perform with dual task. This dual task will be counting down the months of the year starting from December.'}, {'measure': '10 Meter Walk Test with dual task', 'timeFrame': 'Baseline', 'description': "In this test, the participant will walk at the best possible speed in a pre-measured 10-meter area. The time starts when the participant's foot is on the starting line and ends when they cross the finish line. In this test, the result is recorded in total seconds. The participants will perform with dual task. This dual task will be counting numbers back from 100 by threes."}, {'measure': 'Timed 25-Foot Walk Test with dual task', 'timeFrame': 'Baseline', 'description': 'The participant walks the distance of 7.62 meters as fast as possible but without running. The time to complete the distance will recorded in seconds. The participants will perform with dual task. This dual task will be counting numbers back from 100 by sevens.'}, {'measure': '1 min-Sit-to-Stand Test with dual task', 'timeFrame': 'Baseline', 'description': 'Participants put their hands on their hips and they had to stand up and sit down completely and as many times as possible from a chair (height = 46 cm) without arm rests during one minute. Participants are not allowed to use their arms as support. The number of sit-ups performed during 1 minute will recorded. The participants will perform with dual task. This dual task will be counting city names.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dual-task', 'functional test', 'healthy young', 'reference value'], 'conditions': ['Dual-task', 'Functional Test']}, 'referencesModule': {'references': [{'pmid': '34272869', 'type': 'BACKGROUND', 'citation': 'Ahman HB, Berglund L, Cedervall Y, Giedraitis V, McKee KJ, Rosendahl E, Aberg AC. Timed "Up & Go" Dual-Task Tests: Age- and Sex-Specific Reference Values and Test-Retest Reliability in Cognitively Healthy Controls. Phys Ther. 2021 Oct 1;101(10):pzab179. doi: 10.1093/ptj/pzab179.'}]}, 'descriptionModule': {'briefSummary': 'In this study, reference values for the five basic functional tests that are commonly used, with and without the addition of dual-task activity, will be determined. It will be ensured that healthy normative data that researchers and clinicians can compare in determining the effects in different pathologies by using easy-to-perform evaluations. The aim of this study is to determine the reference values performed with and without dual-task of the five functional tests for young adults according to age and gender by considering the interaction between both mobility and cognitive tasks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy young people', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-35 years\n* Individuals who were not diagnosed with musculoskeletal disorder\n* Volunteers\n\nExclusion Criteria:\n\n* Using an assistive device for walking\n* Having cognitive problems\n* Individuals who had undergone lower extremity surgery due to musculoskeletal problems in the last six months\n* Body mass index greater than 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT05373160', 'briefTitle': 'Reference Values of Different Functional Tests With or Without Cognitive Dual-task in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Bilgi University'}, 'officialTitle': 'Determination of Age- and Gender-specific Reference Values of Different Functional Tests With or Without Cognitive Dual-task in Young Adults', 'orgStudyIdInfo': {'id': 'qH25cGJv'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy young group', 'description': 'Individuals who are 18-35 years, did not diagnosed with musculoskeletal disorder, and volunteers', 'interventionNames': ['Other: Assessment study']}], 'interventions': [{'name': 'Assessment study', 'type': 'OTHER', 'description': 'Assessment of functional tests with and without dual tasks', 'armGroupLabels': ['Healthy young group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yildiz Analay Akbaba, PT, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Bilgi University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Cigdem Emirza', 'investigatorAffiliation': 'Istanbul Bilgi University'}}}}