Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-31 @ 11:08 AM
Study NCT ID:
NCT06146959
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-17
First Post:
2023-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corrective Calcaneal Kinesiology Tape in Adolescents With Pronated Foot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055052', 'term': 'Athletic Tape'}], 'ancestors': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-12', 'studyFirstSubmitDate': '2023-11-18', 'studyFirstSubmitQcDate': '2023-11-18', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diagnostic ultrasound', 'timeFrame': '4 weeks', 'description': 'A sonographic picture of plantar fascia'}], 'primaryOutcomes': [{'measure': 'Pain Visual Analogue Scale', 'timeFrame': '4 weeks', 'description': 'minimum score is 0, and the maximum score is 10 ; higher scores means worse outcome'}], 'secondaryOutcomes': [{'measure': 'Foot function Index', 'timeFrame': '4 weeks', 'description': 'This questionnaire has been designed to give therapists information on how foot pain has affected your ability to to manage in everyday life. each question on a scale from 0 (no pain) to 10 (worst pain imaginable)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kinesiology tape , plantar fasciitis'], 'conditions': ['Physical Disability', 'Physical Therapy Modalities']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to find the effect of a program of corrective kinesiotaping on pain intensity, foot function, and the sonographic picture of plantar fascia in adolescents with pronated feet.This study hypothesizes that there will be a statistically significant effect of a program of application of the corrective technique of kinesiotaping on plantar heel pain, foot function, and the sonographic picture of plantar fascia in a sample of Egyptian adolescents suffering from pronated feet.', 'detailedDescription': 'This study will be conducted to find the effect of a program of corrective kinesiotaping on pain intensity, foot function, and the sonographic picture of the plantar fascia in adolescents with pronated feet. Thirty adolescents suffering from plantar heel pain associated with pronated feet will be included in this study. They will be distributed randomly into 2 groups: Group A will receive corrective kinesiotaping (50-75% stretch) for 6 weeks, 2 times per week with 1 day of rest; Group B will receive a home program of intrinsic foot strengthening and stretching exercises. Data will be collected pre- and post-intervention for all groups by using the visual analog scale (VAS), the first two subscales of the foot function index (FFI), and a sonographic picture of the foot for each adolescent. Participants will be recruited from outpatient clinics and schools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with unilateral or bilateral plantar fasciitis.\n* pronated foot or foot on weightbearing in the navicular drops test.\n* Pain and tenderness to palpation at the medial tubercle of the calcaneus for a minimum of 6 weeks and maximum of 6 months\n\nExclusion Criteria:\n\n* Corticosteroid injection of the heel within the past 3 months.\n* Posterior heel pain.\n* Systemic inflammatory conditions.\n* Diabetes.\n* Surgery of the foot.\n* Neuromuscular conditions e.g. CP.\n* Individuals with BMI \\> 25.\n* Individuals engaged in regular athletic activities'}, 'identificationModule': {'nctId': 'NCT06146959', 'briefTitle': 'Corrective Calcaneal Kinesiology Tape in Adolescents With Pronated Foot', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Effect of Corrective Calcaneal Kinesiology Tape on Pain, Function and Sonographic Picture of Plantar Fasciitis in Adolescents With Pronated Foot', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004632'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Group A: will receive corrective kinesiotaping (50-75% stretch) for 4 weeks, 2 times per week, with 1 day rest', 'interventionNames': ['Device: Corrective Kinesiology taping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Group B will receive a home program of intrinsic foot strengthening and stretching exercises.', 'interventionNames': ['Other: Home exercise program']}], 'interventions': [{'name': 'Corrective Kinesiology taping', 'type': 'DEVICE', 'otherNames': ['Kinesiotape'], 'description': 'corrective kinesiology tape is a form of biomechanical tape that is used with specific tension to get a corrective effect', 'armGroupLabels': ['Group A']}, {'name': 'Home exercise program', 'type': 'OTHER', 'description': 'Intrinsic foot strengthening and stretching exercises', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11411', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Tayseer Younes', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Tayseer S Abdeldayem, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beni-Suef University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Azhar University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Tayseer Saber Abdeldayem', 'investigatorAffiliation': 'Beni-Suef University'}}}}