Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-04 @ 5:18 AM
Study NCT ID:
NCT03557866
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2018-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinematic Parameters of Running in Individuals With Pronated Foot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012420', 'term': 'Running'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups. Individuals with and without pronated foot.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-26', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stride length', 'timeFrame': 'up to 6 months', 'description': 'stride length in cm'}, {'measure': 'cadence', 'timeFrame': 'up to 6 months', 'description': 'steps per minute'}], 'secondaryOutcomes': [{'measure': 'velocity', 'timeFrame': 'up to 6 months', 'description': 'running velocity in Km/hour'}, {'measure': 'heel raise test', 'timeFrame': 'up to 6 months', 'description': 'how many good heel raise till fatigue'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['foot posture', 'running', 'foot index'], 'conditions': ['Pronation; Ankle']}, 'referencesModule': {'references': [{'pmid': '19450247', 'type': 'RESULT', 'citation': 'McPoil TG, Cornwall MW, Medoff L, Vicenzino B, Fosberg KK, Hilz D. Arch height change during sit-to-stand: an alternative for the navicular drop test. J Foot Ankle Res. 2009 May 18;2:17. doi: 10.1186/1757-1146-2-17.'}, {'pmid': '19939283', 'type': 'RESULT', 'citation': 'Murley GS, Menz HB, Landorf KB. Foot posture influences the electromyographic activity of selected lower limb muscles during gait. J Foot Ankle Res. 2009 Nov 26;2:35. doi: 10.1186/1757-1146-2-35.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine the kinematic parameters of individuals with pronated foot compared with individuals with normal foot', 'detailedDescription': 'Individual with and without pronated foot will be recruited. Pronation will be defined according to navicular drop test. Inclusion criteria : individual who run on a regular basis at least 3 times per week for one hour, can run 5 Km in less then 40 minutes, without past injuries during the last year of Achilles tendon or other lower extremities pain.\n\nIndividuals will be asked to run for 5 Km in self selected velocity. The Milestone pod device will be used to monitor kinematic parameters.\n\nfunctional test will be conducted before and after the running as follows: heel raise test and one leg hop for distance test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* running on a daily basis at least 3 times per week with minimum of 1 hour\n* capable to run 5 km in less then 40 minutes\n* willing to participate in the study\n\nExclusion Criteria:\n\n* previous surgery in lower extremities\n* Achilles tendon pain during the last year'}, 'identificationModule': {'nctId': 'NCT03557866', 'briefTitle': 'Kinematic Parameters of Running in Individuals With Pronated Foot', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'Kinematic Parameters of Running in Individuals With Pronated Foot', 'orgStudyIdInfo': {'id': '380/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pronated group', 'description': 'individuals with pronated foot', 'interventionNames': ['Diagnostic Test: running']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'individuals with normal foot posture', 'interventionNames': ['Diagnostic Test: running']}], 'interventions': [{'name': 'running', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['kinematic parameters of running'], 'description': 'individuals will be asked to run for 5 km in self selected speed', 'armGroupLabels': ['control group', 'pronated group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'University of Haifa', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Gali Dar, PHd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Haifa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'following completion of data collection', 'ipdSharing': 'YES', 'description': 'the results of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol and results', 'accessCriteria': 'according to journal policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Gali Dar', 'investigatorAffiliation': 'University of Haifa'}}}}