Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-01 @ 8:23 PM
Study NCT ID:
NCT06987435
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elasticity of Structures Around the Ankle in Chronic Ankle Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-05-16', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Ankle Identification', 'timeFrame': 'Baseline', 'description': 'The Functional Ankle Identification method is a scale developed to evaluate the functional ankle instability of individuals.'}, {'measure': 'Foot Posture Index', 'timeFrame': 'Baseline', 'description': 'Foot Posture Index will be applied in this study to evaluate the foot postures of the participants.'}, {'measure': 'Navicular Drop Test', 'timeFrame': 'Baseline', 'description': "The Navicular Drop Test will be administered to measure how much the participants' navicular bones have fallen."}, {'measure': 'Myoton', 'timeFrame': 'Baseline', 'description': "Participants' gastrocnemius, tibialis anterior, peroneus longus, achilles tendon and plantar fascia flexibility will be evaluated using a myotonometer device."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Ankle Instability']}, 'referencesModule': {'references': [{'pmid': '31704588', 'type': 'BACKGROUND', 'citation': 'Tas S, Salkin Y. An investigation of the sex-related differences in the stiffness of the Achilles tendon and gastrocnemius muscle: Inter-observer reliability and inter-day repeatability and the effect of ankle joint motion. Foot (Edinb). 2019 Dec;41:44-50. doi: 10.1016/j.foot.2019.09.003. Epub 2019 Sep 29.'}, {'pmid': '15468023', 'type': 'BACKGROUND', 'citation': 'Rydahl SJ, Brouwer BJ. Ankle stiffness and tissue compliance in stroke survivors: a validation of Myotonometer measurements. Arch Phys Med Rehabil. 2004 Oct;85(10):1631-7. doi: 10.1016/j.apmr.2004.01.026.'}, {'pmid': '16182419', 'type': 'BACKGROUND', 'citation': 'Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the flexibility of the structures around the ankle in individuals with unilateral chronic ankle instability. Individuals between the ages of 18-45 who have been diagnosed with chronic ankle instability by an orthopedist and who have unilateral instability will be included in the study. The flexibility of the healthy and instability sides will be evaluated. Demographic information of the individuals will be recorded and clinical evaluations will be made. The severity of ankle instability will be evaluated with the Functional Ankle Identification (FABIT). The foot posture of the individuals participating in the study will be evaluated with the Foot Posture Index, and the degree of flat feet will be evaluated with the Navicular Drop Test. The flexibility of the gastrocnemius, tibialis anterior, peroneus longus, achilles tendon and plantar fascia of the individuals participating in the study will be measured with a myotonometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with Chronic Ankle Instability', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 to 45\n* Mini Mental State Exam (MMSE) score of 24 to 30\n* Diagnosed with unilateral chronic ankle instability by a physician\n\nExclusion Criteria:\n\n* Inability to communicate verbally\n* Use of a walking aid\n* Any history of lower extremity surgery\n* People with severe visual impairment, neurological disorders and/or congestive heart failure.'}, 'identificationModule': {'nctId': 'NCT06987435', 'briefTitle': 'Elasticity of Structures Around the Ankle in Chronic Ankle Instability', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Flexibility of Structures Around the Ankle in Individuals With Chronic Ankle Instability', 'orgStudyIdInfo': {'id': '604.01.02-423'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Atılım University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Süleyman Korkusuz, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Atılım University'}, {'name': 'Büşra Seçkinoğulları Korkusuz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Busra Seckinogullari Korkusuz', 'investigatorAffiliation': 'Hacettepe University'}}}}