Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT07235267
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reliability and Validity of Tele-Assessment for Functional Performance in Older vs. Younger Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go (TUG)', 'timeFrame': 'Baseline', 'description': 'Time (seconds) to complete the test, assessed face-to-face and via tele-assessment.'}, {'measure': 'Timed Up and Go (TUG)', 'timeFrame': 'One week later', 'description': 'Time (seconds) to complete the test, assessed face-to-face and via tele-assessment.'}, {'measure': '30-second Sit-to-Stand Test (30sSTS)', 'timeFrame': 'Baseline', 'description': 'Number of sit-to-stand repetitions performed within 30 seconds, assessed face-to-face and via tele-assessment.'}, {'measure': '30-second Sit-to-Stand Test (30sSTS)', 'timeFrame': 'One week later', 'description': 'Number of sit-to-stand repetitions performed within 30 seconds, assessed face-to-face and via tele-assessment.'}, {'measure': 'Gait Speed Test (GST)', 'timeFrame': 'Baseline', 'description': 'Gait speed (m/s) over a 4-meter course, assessed face-to-face and via tele-assessment.'}, {'measure': 'Gait Speed Test (GST)', 'timeFrame': 'One week later', 'description': 'Gait speed (m/s) over a 4-meter course, assessed face-to-face and via tele-assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Older Adults (65 Years and Older)', 'Geriatric Health', 'Young Adults']}, 'descriptionModule': {'briefSummary': 'This cross-sectional, comparative study aims to examine the intra-rater reliability, validity, and feasibility of tele-assessment versions of three functional mobility tests-the Timed Up and Go (TUG), 30-second Sit-to-Stand (30sSTS), and Gait Speed Test (GST)-in community-dwelling older adults (≥65 years). To provide a comparative perspective, the same assessments will also be administered to a younger, healthy control group (18-44 years). The study seeks to determine whether tele-assessment can serve as a robust and practical alternative to in-person testing, thereby enhancing accessibility and ensuring high-quality functional evaluation in geriatric populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Older Adults and Younger Adults (as control)', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion Criteria (Older Adults, ≥65 years) Community-dwelling Independent in activities of daily living Able to provide informed consent Capable of performing TUG, 30sSTS, and GST without assistance\n* Inclusion Criteria (Younger Adults, 18-44 years) Healthy individuals without acute or chronic conditions affecting mobility Able to provide informed consent Capable of performing TUG, 30sSTS, and GST independently\n* Exclusion Criteria (both groups) Diagnosed neurological disorders (other than age-related decline) Uncontrolled cardiovascular or metabolic disease Recent surgery or fractures Severe cognitive impairment Contraindications to physical activity Lack of access to required telecommunication technology'}, 'identificationModule': {'nctId': 'NCT07235267', 'briefTitle': 'Reliability and Validity of Tele-Assessment for Functional Performance in Older vs. Younger Adults', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Establishing the Reliability and Validity of Tele-Assessment for Functional Performance in Older Adults: A Comparative Study With Younger Individuals', 'orgStudyIdInfo': {'id': '2025.17031'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Cohort: Older Adults', 'description': 'Primary Cohort (Older adults) included individuals aged ≥65 years, living independently in the community, without severe cognitive, visual, or musculoskeletal impairments that would prevent participation.'}, {'label': 'Comparison Cohort: Young Adults', 'description': 'Comparison Cohort (Young Adults) included healthy individuals aged 18-44 years, without acute or chronic health conditions affecting mobility.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'state': 'Buyukcekmece', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Derya Celik, Professor', 'role': 'CONTACT', 'email': 'deryacelik@iuc.edu.tr', 'phone': '+90 212 866 37 00', 'phoneExt': '28023'}, {'name': 'Sezen Karaborklu Argut, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istanbul University-Cerrahpaşa Faculty of Health Sciences', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Sezen Karaborklu Argut, PhD', 'role': 'CONTACT', 'email': 's.karaborkluargut@iuc.edu.tr', 'phone': '+90 212 866 37 00'}, {'name': 'Sezen Karabörklü Argut, PhD', 'role': 'CONTACT', 'email': 's.karaborkluargut@iuc.edu.tr', 'phone': '+90 212 866 37 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr., Assistant Professor', 'investigatorFullName': 'Sezen Karaborklu Argut', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}