Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:16 PM
Study NCT ID:
NCT07428902
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Of French Method With/Without Brace In Clubfoot Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003025', 'term': 'Clubfoot'}], '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': ['PARTICIPANT'], 'maskingDescription': 'Participants will get separate treatment protocols and possible efforts will be put to mask both groups about the treatment'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "This randomized controlled trial will be conducted at the Pakistan Society for the Rehabilitation of the Disabled (PSRD) and the Children's Hospital and Institute of Child Health, Lahore. Eighteen children aged 0-12 months diagnosed with congenital talipes equinovarus (CTEV) will be randomly divided into two equal groups. Children with neurological, orthopedic, or neuromuscular disorders, prior foot surgery, or severe systemic illness will be excluded. The experimental group will receive the French method with a foot abduction brace, while the control group will receive only the French method. Foot position, deformity severity, and functional mobility will be assessed pre- and post-intervention using the Pirani score and standardized clinical measures. Data will be analyzed using SPSS version 23.0."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pirani Scoring System for Clubfoot Assessment & Demeglio Classification System for Clubfoot Severity', 'timeFrame': 'Baseline,12 weeks', 'description': 'Pirani Scoring System for Clubfoot Assessment:The Pirani Score is a widely used clinical tool to assess the severity of congenital talipes equinovarus (clubfoot). This scoring system helps in evaluating the extent of deformity and in monitoring the progress of treatment, especially when using methods like the Ponseti method or the French method. It focuses on six key aspects of the foot, Each of these six components is scored from 0 to 1.The total score ranges from 0 (normal foot) to 6 (severely affected foot). The higher the score, the more severe the clubfoot.'}], 'secondaryOutcomes': [{'measure': 'Demeglio Classification System for Clubfoot Severity', 'timeFrame': 'Baseline,12 weeks', 'description': 'DimS is based on correction after applying a gentle reduction force.6 Four parameters are evaluated: varus (VA), equinus (E-Dim), derotation of calcaneo-forefoot block (DER) and midfoot adduction (ADD). Each is scored on a five-point scale (0 to 4 points) resulting in a maximum score of 16 points for the most severe deformity. An additional four points result from the absence/presence (0/1 point) of four pejorative items: posterior crease (PC-Dim), medial crease (MC-Dim), cavus and abnormal musculature (MUSC). Once a total score (0 to 20 points) is calculated, feet are divided in four grades: grade I (0-5 points), II (6-10), III (11-15) and IV (16-20 points).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clubfoot, French Method, Foot Abduction Brace'], 'conditions': ['Club Foot']}, 'referencesModule': {'references': [{'pmid': '31695815', 'type': 'BACKGROUND', 'citation': 'Bettuzzi C, Abati CN, Salvatori G, Zanardi A, Lampasi M. Interobserver reliability of Dimeglio and Pirani score and their subcomponents in the evaluation of idiopathic clubfoot in a clinical setting: a need for improved scoring systems. J Child Orthop. 2019 Oct 1;13(5):478-485. doi: 10.1302/1863-2548.13.190010.'}]}, 'descriptionModule': {'briefSummary': 'The current study will be a randomized control trial. Data will be collected from the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD) and the Children Hospital and Institute of Child Health, Lahore. The study will include 18 patients, equally divided into two groups and randomly allocated. Inclusion criteria will be children aged 0 to 12 months diagnosed with CTEV of either gender. Patients with neurological conditions, other orthopedic issues, previous surgical history related to the foot, severe systemic disorders, or neuromuscular disorders will be excluded from the study. The experimental group will receive the French method along with a foot abduction brace, while the control group will receive only the French method without the brace. Outcomes to be analyzed will include foot position, severity of deformity, and functional mobility. Data collection will occur before and after the intervention, utilizing clinical assessments for foot position, the Pirani score for severity of deformity, and standardized mobility assessments. Data will be analyzed using SPSS version 23.00.', 'detailedDescription': "Clubfoot, or talipes equinovarus, is a structural deformity of the foot and ankle characterized by hind foot equinus (plantar flexion), Varus of the heel (internal rotation), supination, and forefoot adduction (plantar cavus). The severity can range from mild to extremely rigid, manipulation-resistant cases. The incidence of clubfoot varies geographically, with a prevalence ranging from 0.5 to 2.0 cases per 1,000 live births across different regions. Early and effective intervention is crucial to prevent long-term disability, gait abnormalities, and functional limitations The French method, a conservative approach is widely used in treating CTEV. This approach involved daily manipulation of the newborn's foot, muscle stimulation (especially of the peroneal muscles), and temporary immobilization with adhesive strapping. However, the need for prolonged foot abduction bracing as a complement to the French method remains debatable. This study aims to compare the effects of the French method with and without the use of a foot abduction brace in managing CTEV in children.\n\nThe current study will be a randomized control trial. Data will be collected from the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD) and the Children Hospital and Institute of Child Health, Lahore. The study will include 18 patients, equally divided into two groups and randomly allocated. Inclusion criteria will be children aged 0 to 12 months diagnosed with CTEV of either gender. Patients with neurological conditions, other orthopedic issues, previous surgical history related to the foot, severe systemic disorders, or neuromuscular disorders will be excluded from the study. The experimental group will receive the French method along with a foot abduction brace, while the control group will receive only the French method without the brace. Outcomes to be analyzed will include foot position, severity of deformity, and functional mobility. Data collection will occur before and after the intervention, utilizing clinical assessments for foot position, the Pirani score for severity of deformity, and standardized mobility assessments. Data will be analyzed using SPSS version 23.00."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under 12 months of age with clubfeet.\n* All patients without previous clubfoot surgery were included.\n* Children who have not received any prior corrective treatment or bracing for CTEV.\n\nExclusion Criteria:\n\n* Patients with prior clubfoot surgery were excluded.\n* Non-idiopathic cases (patients with underlying conditions) typically did not respond well to the nonoperative interventions and were less likely to be included for purely nonoperative treatment.'}, 'identificationModule': {'nctId': 'NCT07428902', 'briefTitle': 'Effects Of French Method With/Without Brace In Clubfoot Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects Of French Method With And Without Foot Abduction Brace In Children With Congenital Talipes Equinovarus', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/SHAMAKHIZAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A:Intervention Group(French Method with Foot Abduction Brace)', 'description': 'The experimental group will receive the French method with a foot abduction brace worn to maintain correction.', 'interventionNames': ['Other: French method and Foot Abduction Brace']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B:Control Group(French Method only)', 'description': 'The control group will receive the French method only, without a foot abduction brace.', 'interventionNames': ['Other: French Method only']}], 'interventions': [{'name': 'French method and Foot Abduction Brace', 'type': 'OTHER', 'description': 'The experimental group will follow the French method with the addition of a foot abduction brace, which is worn after each session.', 'armGroupLabels': ['Group A:Intervention Group(French Method with Foot Abduction Brace)']}, {'name': 'French Method only', 'type': 'OTHER', 'description': 'The control group will receive the French method only, without a foot abduction brace. The intervention includes manual manipulation to correct deformities through soft tissue stretching and joint mobilization; stretching exercises for dorsiflexion, abduction, and eversion to maintain range of motion; and taping for stabilization after manipulation. Gentle calf and foot massage will reduce stiffness and promote relaxation. Daily sessions of 30-45 minutes will be conducted for 2-3 months. Parents will be trained to perform gentle stretches, monitor foot position, recognize signs of poor circulation or discomfort, and apply taping correctly. They will be advised to continue exercises at home between follow-up visits to maintain correction and ensure continued improvement.', 'armGroupLabels': ['Group B:Control Group(French Method only)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Asif Javed, MSPT', 'role': 'CONTACT', 'email': 'a.javed@riphah.edu.pk', 'phone': '923224209422'}], 'facility': 'Pakistan Society for the Rehabilitation of the Disabled', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'IMRAN AMJAD, PhD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '9233224390125'}, {'name': 'Muhammad Asif Javed, MS-PT', 'role': 'CONTACT', 'email': 'a.javed@riphah.edu.pk', 'phone': '923224209422'}], 'overallOfficials': [{'name': 'Shama Khizar, MSPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}