Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT07140861
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Core Stability Exercises in Individuals With Bilateral Flexible Flat Foot
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Navicular height', 'timeFrame': 'at enrollment and at the end of 6 weeks of treatment'}, {'measure': 'Balance', 'timeFrame': 'at enrollment and at the end of 6 weeks of treatment', 'description': 'Dynamic balance will be assessed by Biodex system'}], 'secondaryOutcomes': [{'measure': 'Medial longitudinal arch height', 'timeFrame': 'at enrollment and at the end of 6 weeks of treatment'}, {'measure': 'Function of ankle joint', 'timeFrame': 'at enrollment and at the end of 6 weeks of treatment', 'description': 'Function of ankle joint will be assessed by Arabic version of foot function index scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['core stability exercises', 'medial longitudinal arch height', 'balance', 'bilateral flexible flat foot'], 'conditions': ['Flat Feet']}, 'descriptionModule': {'briefSummary': 'There is a gap of literature about the role of core stability exercises on management of flexible flatfoot, as a result this study will take a deeper look on the effect of core stability exercises on navicular height, Arch height index, balance and disability function of ankle joint in individuals with bilateral flexible flat foot.', 'detailedDescription': 'It was proved that Individuals with flexible flat foot have reduced core stability. Thus, core stability must be assessed while treating individuals with flexible flat foot and interventions that address core stability must be included in the treatment of flexible flat foot . It was demonstrated that there was a poorer balance in individual with bilateral flexible flat foot. Therefore, it is recommended to add balance training exercises to traditional physical therapy program in cases of flatfoot patients .\n\n40 Participants of both genders with bilateral flexible flatfoot. will be assigned randomly into 2 equal groups: Group A (control group): will receive conventional therapy. Group B (Experimental group): will receive core training protocol and conventional therapy. Subjects will receive 3 sessions per week for 6 weeks.\n\nOutcome measures:\n\n1. Navicular height: will be evaluated by navicular drop test.\n2. Medial longitudinal arch height: will be evaluated by Arch height index (AHI).\n3. Balance: will be evaluated by Biodex Balance System.\n4. Disability function of ankle joint: will be evaluated by Arabic version of foot function index scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 40 Participants of both genders with bilateral flexible flatfoot.\n2. Their age ranges from 18 to 39 years.\n3. All Participants with a navicular drop (ND) greater than 10 mm.\n4. Body mass index from 18.5-25 kg/m2\n\nExclusion Criteria:\n\n1. Traumatic condition of the lower limbs.\n2. History of Fracture of the lower limbs.\n3. previous orthopedic disorders or neurologic deficit of the lower limbs.\n4. Previous surgery of the lower limbs.\n5. Any sensory problems.\n6. Leg length discrepancy.\n7. Neuromuscular disease like multiple scelerosis.\n8. Unilateral flexible flat foot.\n9. Rigid flat foot.\n10. Any lumbar spine problems'}, 'identificationModule': {'nctId': 'NCT07140861', 'briefTitle': 'Effect of Core Stability Exercises in Individuals With Bilateral Flexible Flat Foot', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Core Stability Exercises on Medial Longitudinal Arch Height and Balance in Individuals With Bilateral Flexible Flat Foot', 'orgStudyIdInfo': {'id': 'Physical Therapy 52043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Control group will receive conventional treatment', 'interventionNames': ['Other: Conventional']}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Study group: will receive core training protocol and conventional therapy.', 'interventionNames': ['Other: Conventional', 'Other: Experimental']}], 'interventions': [{'name': 'Conventional', 'type': 'OTHER', 'description': 'patients will receive conventional therapy that include\n\n1. Short foot exercises\n2. Towel-curl exercise\n3. Heel raise exercise\n4. Calf stretch', 'armGroupLabels': ['Control group', 'Study group']}, {'name': 'Experimental', 'type': 'OTHER', 'description': 'Core stability exercises:\n\nThe training programs will last 6 weeks and comprise 3 training sessions per week. Each training session lasted 30 min, starting with a brief, standardized warm-up program mainly consisting of low-intensity core strength exercises to prepare the neuromuscular system for the training loads and ending with a cool-down program (i.e., dynamic stretching). During the main part of training, research group will conduct the "big 3" exercises as described by McGill (Mcgill, 2001). These include the curl-up, side bridge, and quadruped position. In other words, every single training session consisted of frontal, dorsal, and lateral core exercises. Training intensity will be progressed and individually increased over the 6-week training program by modulating lever lengths, movement velocity', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Abdou', 'role': 'CONTACT', 'email': 'ahmed_pt2010@cu.edu.eg', 'phone': '00201005591580'}], 'facility': 'Physical therapy College - Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Doaa Assistant professor of physical therapy, Assistant professor', 'role': 'CONTACT', 'email': 'doaa.rafat@pt.cu.edu.eg', 'phone': '00201005591580'}], 'facility': 'Physical Therapy faculty, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Doaa Rafat Assistant professor of physical therapy - Cairo university, Assistant professor', 'role': 'CONTACT', 'email': 'doaa.rafat@pt.cu.edu.eg', 'phone': '201005591580'}, {'name': 'Mohamed Elgendy Professor of physical therapy - Cairo university', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Magda Gaid Professor of physical therapy - Cairo University', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Basic sciences for physical therapy, Faculty of Physical Therapy , Cairo university, Cairo, Egypt'}, {'name': 'Ahmed Abdou, Assistant lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Basic sciences for physical therapy, Faculty of Physical Therapy , Cairo university, Cairo, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of physical therapy', 'investigatorFullName': 'Doaa Rafat', 'investigatorAffiliation': 'Cairo University'}}}}