Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT04720651
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2021-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Calf Muscle Tightness in Flat Foot Subjects
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 174}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-19', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tightness of the calf muscle', 'timeFrame': '3 months', 'description': 'measuring of ankle dorsi flexion range of motion with knee extension and with knee flexion in flat foot subjects with navicular drop more than 1 cm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flat Feet']}, 'referencesModule': {'references': [{'pmid': '14560897', 'type': 'BACKGROUND', 'citation': 'Meehan RE, Brage M. Adult acquired flat foot deformity: clinical and radiographic examination. Foot Ankle Clin. 2003 Sep;8(3):431-52. doi: 10.1016/s1083-7515(03)00019-6.'}, {'pmid': '17017268', 'type': 'BACKGROUND', 'citation': 'Tome J, Nawoczenski DA, Flemister A, Houck J. Comparison of foot kinematics between subjects with posterior tibialis tendon dysfunction and healthy controls. J Orthop Sports Phys Ther. 2006 Sep;36(9):635-44. doi: 10.2519/jospt.2006.2293.'}, {'pmid': '14560896', 'type': 'BACKGROUND', 'citation': 'Van Boerum DH, Sangeorzan BJ. Biomechanics and pathophysiology of flat foot. Foot Ankle Clin. 2003 Sep;8(3):419-30. doi: 10.1016/s1083-7515(03)00084-6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the current work is to determine the prevalence of calf muscle tightness in asymptomatic flat foot subjects.', 'detailedDescription': 'Pes planus (Flat foot) deformity is a common chronic foot and ankle condition characterized by flattening of the medial longitudinal arch (MLA), rearfoot valgus and abduction of the midfoot on the hind foot.\n\nA flexible pes planus is caused by tibialis posterior dysfunction, ligament loosening, Achilles tendon shortening, and weakness of the intrinsic foot muscles. These deformations cause plantar flexion and adduction of the talus bone and valgus of the calcaneus bone.\n\nUp to our knowledge:\n\n1. No previous studies investigated whether all flat foot is usually associated with gastrocnemius and soleus muscle tightness or it is a random association.\n2. And whether tightness of gastrocnemius and soleus is highly found in all cases of flat foot.\n\nConsequently this study is conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with flexible flat foot aged between 20 and 40 years old . They should have navicular drop more than 10 mm and their body mass index is between 18.5 kg/m2 to 29.9 kg/m2.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects should have flexible flat foot.\n2. Age between 20 and 40 years.\n3. Navicular drop of more than 10 mm.\n4. Body Mass Index from 18.5 kg/m2 to 29.9 kg/m2.\n5. Subjects will sign the written consent form after the aim and methods of the study are explained clearly.\n\nExclusion Criteria:\n\n1. Subjects with history of foot and ankle surgery, trauma, fracture or dislocation.\n2. Subjects with congenital deformities in the ankle and foot.\n3. Subjects with systemic or neurologic diseases that could affect lower extremity biomechanics.'}, 'identificationModule': {'nctId': 'NCT04720651', 'briefTitle': 'Calf Muscle Tightness in Flat Foot Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence of Calf Muscle Tightness in Asymptomatic Flat Foot Subjects', 'orgStudyIdInfo': {'id': 'Calf muscle in flat foot'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sara Hassan, Bachelor', 'role': 'CONTACT', 'email': 'Sara.Hassan@buc.edu.eg', 'phone': '+20-01068999632'}, {'name': 'Enas Fawzy, Professor', 'role': 'CONTACT', 'email': 'enas.fawzy@pt.cu.edu.eg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assisstant', 'investigatorFullName': 'Sara Hassan Kamel', 'investigatorAffiliation': 'Cairo University'}}}}