Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT06251804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Short-Foot Exercises in Water and on Land in Pes Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005413', 'term': 'Flatfoot'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foot Posture Index', 'timeFrame': '6 weeks', 'description': 'A widely used method to assess foot posture and classify individuals according to different foot types.\n\nEach criterion is scored on a 5-point scale ranging from -2 to +2.'}, {'measure': 'Navicular Drop Test', 'timeFrame': '6 weeks', 'description': 'It is a clinical assessment used to evaluate the degree of foot pronation or flattening of the medial longitudinal arch during weight bearing. It is commonly used to assess foot pronation, especially the vertical displacement of the navicular bone during weight bearing.'}, {'measure': 'Biodex Balance System', 'timeFrame': '6 weeks', 'description': 'It is a computerized balance assessment system widely used in clinical and research settings to assess and improve balance and stability. The Biodex Balance System typically consists of a computerized platform with force sensors, visual feedback display and various training modes. It provides quantitative measurements of balance parameters, allowing accurate assessment and monitoring of progress'}], 'secondaryOutcomes': [{'measure': 'Pittsburg Sleep Index', 'timeFrame': '6 weeks', 'description': 'It is a widely used scale that evaluates sleep quality and disorders related to sleep problems.\n\nThe Pitssburg sleep index includes 19 questions Each question is scored from 0 to 3 points, with a high score indicating poor sleep quality. The scale has a total score with a minimum score of 0 and a maximum score of 21 points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pes Planus']}, 'descriptionModule': {'briefSummary': 'Pes planus is caused by the elongation of the intrinsic muscles in the medial arch of the foot, causing the arch to approach the ground or the sole of the foot to touch the ground completely.', 'detailedDescription': 'For this purpose, in this project, the effectiveness of short foot exercises in water and on land will be compared in young adults with pes planus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-25\n* Having bilateral pes planus\n* People with a score of 6 and above on the Foot Posture Index Score\n* Individuals with more than 10 millimeters of pronation according to the navicular drop test were included.\n\nExclusion Criteria:\n\n* Rigid pes planus, hallux valgus, hallux rigidus, epin calcanei\n* Lower extremity surgery\n* Neurological or orthopedic problems and history of disease\n* Regular exercise for the treatment of pes planus in the last three months'}, 'identificationModule': {'nctId': 'NCT06251804', 'briefTitle': 'Effectiveness of Short-Foot Exercises in Water and on Land in Pes Planus', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Effectiveness of Short-Foot Exercises in Water and on Land in Pes Planus', 'orgStudyIdInfo': {'id': '2023-19/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Water exercise program', 'description': 'The treatment program includes in-water exercise program. Participants will be exercised twice a week for six weeks.', 'interventionNames': ['Other: Water exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Land-based-program', 'description': 'The treatment program includes land-based exercise program. Participants will be exercised twice a week for six weeks.', 'interventionNames': ['Other: Land-based-program']}], 'interventions': [{'name': 'Water exercise program', 'type': 'OTHER', 'description': 'The exercise program includes a short foot exercise and will be given in water.', 'armGroupLabels': ['Water exercise program']}, {'name': 'Land-based-program', 'type': 'OTHER', 'description': 'The exercise program includes a short foot exercise and will be given on land.', 'armGroupLabels': ['Land-based-program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bahçehir University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Hazal GENÇ, PhD', 'role': 'CONTACT', 'email': 'hazaloksuz@gmail.com', 'phone': '+905413204291'}, {'name': 'Mustafa Emre Kıyık', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hazal genc', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}