Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-29 @ 1:42 AM
Study NCT ID:
NCT06294093
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2024-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure
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': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultrasound tissue characterized', 'timeFrame': 'baseline', 'description': 'percentage of type 1,2,3,4 fibers within the tendon'}, {'measure': 'Balance test', 'timeFrame': 'baseline', 'description': 'Y Balance Test - composite score: sum of 3 reach directions in centimeters divided by 3 times the limb length then multiplied by 100'}, {'measure': 'Proprioception test', 'timeFrame': 'baseline', 'description': 'AMEDA device - scores between 0 and 1, A higher score represents better proprioception ability.'}, {'measure': 'muscle strength test', 'timeFrame': 'baseline', 'description': 'hand held dynamometer dynamometer assessment of Gastrocnemius muscle'}, {'measure': 'endurance test gastrocnemius muscle', 'timeFrame': 'baseline', 'description': 'number of single leg heel raise test until fatigue'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Achilles tendon', 'running'], 'conditions': ['Achilles Tendon Injury']}, 'referencesModule': {'references': [{'pmid': '31762215', 'type': 'BACKGROUND', 'citation': 'Dar G, Waddington G, Stern M, Dotan N, Steinberg N. Differences Between Long Distance Road Runners and Trail Runners in Achilles Tendon Structure and Jumping and Balance Performance. PM R. 2020 Aug;12(8):794-804. doi: 10.1002/pmrj.12296. Epub 2020 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners.', 'detailedDescription': 'Healthy runners (road and treadmill runners) who run regularly at least twice a week for half an hour, over 80% of the training on the treadmill or road, will be recruited for the study.\n\nAll subjects will fill out a demographic questionnaire for personal details (age, sex, height, weight, past injuries, training). Each participant will undergo functional tests in random order: 1. Examination of the morphology of the Achilles tendon - will be examined by ultrasound tissue characterized (UTC) 2. Balance test - Y Balance Test 3. Proprioception test - AMEDA device 4. Muscle strength test - manual dynamometer for testing gastrocnemius muscle strength. 5. Gastrocnemius muscle endurance test - single leg heel raise test until fatigue.\n\nA comparison will be made between the two study groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy runners who run on a regular basis, without injuries or pain during the last 6 months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* run regularly at least twice a week for half an hour,\n* over 80% of the training on a treadmill or road\n\nExclusion Criteria:\n\n* pain or injury to Achilles tendon during the 6 months, preventing running for at least 3 days.\n* past Achilles tendon surgeries,\n* sprained ankle in the last six months,\n* lower limb and back pain while running\n* participants who report running with minimalist shoes.'}, 'identificationModule': {'nctId': 'NCT06294093', 'briefTitle': 'Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure, Muscle Strength, Proprioception and Balance Performance', 'orgStudyIdInfo': {'id': '026/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'treadmill group', 'description': 'healthy subjects who run regularly at least twice a week for half an hour, over 80% of the training on treadmill.'}, {'label': 'road group', 'description': 'healthy subjects who run regularly at least twice a week for half an hour, over 80% of the training on road.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Nili Steinberg, PhD', 'role': 'CONTACT', 'email': 'knopp@l-w.ac.il'}], 'facility': 'The Academic College at Wingate', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'Gali Dar, Prof', 'role': 'CONTACT', 'email': 'galidar@yahoo.com', 'phone': '+972505662054'}], 'overallOfficials': [{'name': 'Gali Dar, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Haifa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zinman College of Physical Education and Sports Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gali Dar', 'investigatorAffiliation': 'University of Haifa'}}}}