Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT05821803
Status:
COMPLETED
Last Update Posted:
2023-04-20
First Post:
2023-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Exercise Training and Arch Supported Insoles on Balance and Vertical Jump Performance in Football Players With Foot Pronation Deformity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Navicular Drop Test', 'timeFrame': '4 weeks', 'description': 'It is the one of the static foot assessment tool and is intended to represent the sagittal plane displacement of the navicular tuberosity from a neutral position.'}, {'measure': 'Y Balance Test/ Dynamic Balance Evaluation', 'timeFrame': '4 weeks', 'description': 'The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception. It is a measure of dynamic balance that provides a significant challenge to athletes and physically active individuals.'}, {'measure': 'Flamingo Balance Test/ Static Balance Evalutaion', 'timeFrame': '4 weeks', 'description': 'The flamingo balance test is a total body balance test in order to test static balance.'}, {'measure': 'Vertical Jump Test', 'timeFrame': '4 weeks', 'description': "Vertical jump test to determine an athlete's physical ability. The vertical jump as a test of lower body explosive power"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Foot pronation', 'Insoles', 'Footcore exercises'], 'conditions': ['Foot; Pronation, Congenital']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of foot pronation exercises and arch support insoles on balance and vertical jump test in football players.', 'detailedDescription': 'The study took place in FootBalance Turkey, which works on foot analysis and insoles.\n\n30 professional football players with pronation who divided into two groups. The football players in the Experimental Group used insoles and also participated the foot core exercise program twice a week for 4 weeks duration. The football players in the Control Group just used the insoles.We used the FootBalance assessmnet system for insoles. Navicular Drop Test, Y Balance Test, Flamingo Testand Vertical Jump Test applied to evalute foot pronation, dynamic balance, static balance and jump performace respectively.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntary participation in research\n2. To be between the ages of 18-45\n3. Overpronation foot ( navicular drop test over 10 mm and FootBalance device with visual display)\n4. Professional football players at least 5 years\n\nExclusion Criteria:\n\n1. History of surgery for musculoskeletal structures in both lower extremities\n2. History of fracture in both lower extremities\n3. Acute injury of the musculoskeletal structures of other joints of the lower extremity affecting joint function and integrity in the last 3 months\n4. Have any other knee pathology\n5. Balance or vestibular disorder'}, 'identificationModule': {'nctId': 'NCT05821803', 'briefTitle': 'The Effect of Exercise Training and Arch Supported Insoles on Balance and Vertical Jump Performance in Football Players With Foot Pronation Deformity', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'The Effect of Exercise Training and Arch Supported Insoles on Balance and Vertical Jump Performance in Football Players With Foot Pronation Deformity: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GizemK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Insoles\n\nFoot Core Exercises', 'interventionNames': ['Other: Using Insoles', 'Other: Foot Core Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Insoles', 'interventionNames': ['Other: Using Insoles']}], 'interventions': [{'name': 'Using Insoles', 'type': 'OTHER', 'description': 'FootBalance %100 Control Orthopedic insoles used for 4 weeks.', 'armGroupLabels': ['Control Group', 'Experimental Group']}, {'name': 'Foot Core Exercises', 'type': 'OTHER', 'description': '4 weeks including', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Şişli', 'country': 'Turkey (Türkiye)', 'facility': 'FootBalance Merkez', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'FootBalance', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Gizem Karadeniz', 'investigatorAffiliation': 'Yeditepe University'}}}}