Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-18 @ 12:43 AM
Study NCT ID:
NCT06539533
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2024-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilates on Dynamic Balance in Flexible Flat Feet
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': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2024-07-28', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dynamic balance', 'timeFrame': '6months', 'description': 'is the ability to remain standing and stable while performing movements or actions that require displacing or moving oneself. In this way, each time that we take a step in any direction, we will be testing this type of balance. And, of course, the ability to walk requires its continuous use.\n\nBalance check 636 device (Dr Wolff, Arnsberg, Germany)for assessment of dynamic balance in each subject individually'}], 'secondaryOutcomes': [{'measure': 'quialty of life', 'timeFrame': '6months', 'description': 'sense of wellbeing embracing the physical, psychological, social, and spiritual state. • Foot function index Questionnaire (FFI) for quality of life assessment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flexible Flatfoot']}, 'descriptionModule': {'briefSummary': "Flexible flatfoot is one of the most common types of flatfeet. It has an arch that is present in open kinetic chain and lost in closed kinetic chain Balance is defined as the process that maintains the center of gravity within the body's support base.\n\nPilates exercises is a whole body conditioning program which was initially used for managing low back pain and improving balance in elderly. Now-a-days it is used for posture correction and fitness training.", 'detailedDescription': 'Individuals with flatfeet are more unstable when compared with normal individuals during quiet standing. About 10% to 25% of population exhibits a flat foot to varying degrees. In clinical practice, some subjects become symptomatic with feet pain or lower extremity soreness and limitation in their functional activities such as limitation of long-distance walking or running and high-impact sports.Patients with flexible flat feet have poorer static and dynamic balance than healthy individuals. Taking into consideration effect of flat feet on body alignment, the implication of flat feet on balance have received little attention to date Pilates is an individual body-based exercise, it has an advantage in that exercise load can be controlled according to the body\'s center of balance.Pilates based exercise works on the principles of trunk stability, also known as "core stability". "Core is described as a box, with the abdominals (transversus) in front, paraspinals (multifidus) in back, diaphragm in top and pelvic floor at the bottom". Pilates is a popular form of exercise training program which includes series of stretching and strengthening exercises with proper trunk control and breathing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '21 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject's age ranged from 18-21 years old\n2. Subjects had bilateral pronated feet posture according to the Navicular Drop Test by Brody method: normal feet (between five and nine mm of navicular drop), a pronated foot (more than 10 mm of navicular drop)\n3. Body Mass Index (MBI) ranged from 18.5 to 25 kg/ m2\n\nExclusion Criteria:\n\n* 1-Repeated lower extremity injuries as fractures or deformities. 2-History of surgery to the lower extremity. 3- Any neurological deficit affecting balance. 4-Any medication can affect the balance. 5- pregnant and breast feeding females"}, 'identificationModule': {'nctId': 'NCT06539533', 'briefTitle': 'Pilates on Dynamic Balance in Flexible Flat Feet', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Pilates Training on Dynamic Balance in Flexible Flat Feet', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Experimental group):22 subjects', 'description': '22 subjects will receive Pilates training. twice a week for 5 consecutive weeks, with The duration of Pilates is 30 minutes. 10 repetitions for each exercise with 10 seconds of rest between each Pilates.And short feet exercises daily 3 minutes per time, for a total of five weeks', 'interventionNames': ['Other: pilates training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (control group):22 subjects', 'description': '22 subjects will receive short feet exercise daily 3 minutes per time for a total of five weeks.', 'interventionNames': ['Other: pilates training']}], 'interventions': [{'name': 'pilates training', 'type': 'OTHER', 'otherNames': ['short feet exercises'], 'description': 'The Pilates that will be used in this study are articulating bridge, Hundreds, Plank , rolls up, one leg stretch, lift leg supine.', 'armGroupLabels': ['Group A (Experimental group):22 subjects', 'Group B (control group):22 subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of physical therapy basic science departement', 'investigatorFullName': 'Nora Mohamed Badran', 'investigatorAffiliation': 'Cairo University'}}}}