Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-22 @ 11:26 AM
Study NCT ID:
NCT06606392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Biodex Balance Training and Short Foot Exercise on Myoelectric Activity of Paraspinal Muscles in Subjects with Flexible Flatfoot
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle myoelectric activity', 'timeFrame': '4 weeks', 'description': 'myoelectric activity of paraspinal muscles measured by surface electromygraphy'}, {'measure': 'Foot print pressure', 'timeFrame': '4 weeks', 'description': 'Using myopressure force platform to measure average peak planter pressure'}, {'measure': 'Dynamic balance', 'timeFrame': '4 weeks', 'description': 'Biodex balance system will be used to assess balance before and after treatment'}, {'measure': 'Functional ankle instability index', 'timeFrame': '4 weeks', 'description': 'Cumberland Ankle Instability Tool The CAIT is a nine-item questionnaire intended to identify and grade ankle instability'}, {'measure': 'Pain severity', 'timeFrame': '4 weeks', 'description': 'Evaluation of lower back pain severity by using visual analogue scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flat foot, Myoelectric activity, Biodex balance'], 'conditions': ['Flat Foot']}, 'referencesModule': {'references': [{'pmid': '28764143', 'type': 'BACKGROUND', 'citation': 'Aenumulapalli A, Kulkarni MM, Gandotra AR. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J Clin Diagn Res. 2017 Jun;11(6):AC17-AC20. doi: 10.7860/JCDR/2017/26566.10059. Epub 2017 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to see the effect of the combination of biodex balance system and short foot exercise in the treatment of subjects with flexible flat foot. The main question is the effect of biodex balance training and short foot exercise on myoelectric activity of subjects with flexible flat foot experimental participant will receive biodex balance system exercise and short foot exercise for 4 weeks controlled participant will receive short foot exercise and stretching exercise for 4 weeks Assessment will be done pre and post treatment by using Navicular drop test Myoelectric activity of paraspinal muscle Dynamic balance Pain severity Functional ankle instability inder'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Sixty subjects from both gender with bilateral flexible flat foot will be selected with their age between 18 to 30Years old 2) Body Mass Index (BMI) was ranging from 18 to 25 kg/m2 3) The participants were eligible to be included if had bilaterally FFF according to the navicular drop test 4) Required participant to have been diagnosed (by an orthopedist) with flexible flat foot\n\nExclusion Criteria:\n\n* Repeated lower extremity injuries as fractures or deformities. 2) History of surgery to the lower extremity. 3) History of cerebral concussions, and visual or vestibular disorders. 4) Any neurological deficit affecting balance. 5) Any medication can affect the balance 6) Any problem of lumbar spine( disc,spondylolisthrsis)'}, 'identificationModule': {'nctId': 'NCT06606392', 'briefTitle': 'Effect of Biodex Balance Training and Short Foot Exercise on Myoelectric Activity of Paraspinal Muscles in Subjects with Flexible Flatfoot', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Biodex Balance Training and Short Foot Exercise on Myoelectric Activity of Paraspinal Muscles in Subjects with Flexible Flatfoot', 'orgStudyIdInfo': {'id': 'BSM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': 'Group A 30 subjects will receive short foot exercise and stretching exercise gastrocnemius, soleus muscle and planter fascia stretch.', 'interventionNames': ['Other: Short Foot Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group B will receive Biodex balance training and short foot exercise.', 'interventionNames': ['Device: Biodex balance system', 'Other: Short Foot Exercise']}], 'interventions': [{'name': 'Biodex balance system', 'type': 'DEVICE', 'description': 'The Biodex Balance System has a wide range of clinical applications and provides objective measures from testing that can be used to establish progressions and discharge criteria, as well as be part of a comprehensive Fall Risk Assessment or Fall Screening Program. Balance ability can be assessed either statically or dynamically, as well as bilaterally and unilaterally. It also allows for bilateral comparisons between involved and uninvolved limbs.', 'armGroupLabels': ['Group B']}, {'name': 'Short Foot Exercise', 'type': 'OTHER', 'description': 'Short foot exercise is used as a therapeutic exercise to strengthen intrinsic foot muscles and used as training to create an MLA. It helps improve the balance in functional movement of FF subjects, decreases navicular drop (ND) through intrinsic muscle activation, supports navicular stability, and improves balance', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Modern university for technology and science', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Hager Mahmoud Elsayed, Master Degree', 'role': 'CONTACT', 'email': 'hager.elsherif@hotmail.com', 'phone': '00201118602016'}, {'name': 'Naguib Salem Professor, Doctoral degree', 'role': 'CONTACT', 'phone': '0020111806121'}, {'name': 'Hager Mahmoud Elsayed, Master degree', 'role': 'CONTACT'}, {'name': 'Ragia Mohamed kamal, Doctoral', 'role': 'CONTACT'}, {'name': 'Naglaa Fathy Awes, Doctoral', 'role': 'CONTACT'}, {'name': 'Hend Hamdy Mohamed, Doctoral', 'role': 'CONTACT'}], 'facility': 'Modern university for technology and science', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hager M Elsayed, Master degree', 'role': 'CONTACT', 'email': 'Hager.elsherif@hotmail.com', 'phone': '+201118602016'}, {'name': 'Hend H Mohamed, Doctoral degree', 'role': 'CONTACT', 'email': 'Hendhamdy110@yahoo.com', 'phone': '+201226827307'}], 'overallOfficials': [{'name': 'Ragia M kamal, Doctoral', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor of physical therapy , cairo university'}, {'name': 'Naglaa F Awes, Doctoral', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor of physical therapy cairo universiy'}, {'name': 'Hend H Mohamed, Doctoral', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of physical therapy cairo university'}, {'name': 'Hager M Elsayed, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant lecturer of faculty of physical therapy, modern university for technology and science'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MTI University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer basic science department of faculty of physical therapy modern university for technology and science', 'investigatorFullName': 'Hager Mahmoud mohamed elsayed', 'investigatorAffiliation': 'MTI University'}}}}