Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-02 @ 5:51 PM
Study NCT ID:
NCT05316051
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2022-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet
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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2022-03-19', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower limb kinematics', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Lower limb kinematics will be processed and calculated using a motion capture system (SMART-DX, BTS Bioengineering, Milan, Italy). The following kinematic variables will be obtained for each subject : (i) maximum hip extension angle, (ii) maximum hip adduction angle, (iii) maximum hip external rotation angle, (iv) maximum knee flexion angle during loading response, (v) maximum knee extension angle during midstance, (vi) maximum knee flexion angle at toe off, (vii) minimum knee abduction angle, (viii) maximum knee abduction angle, (ix) maximum knee external rotation angle, (x) maximum knee internal rotation angle, (xi) maximum ankle plantarflexion angle during loading response, (xii) maximum ankle dorsiflexion angle during midstance, (xiii) maximum ankle plantarflexion angle at toe off, (xiv) maximum ankle external rotation angle, (xv) maximum ankle internal rotation angle.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flexible Flatfoot']}, 'descriptionModule': {'briefSummary': 'Inverted orthosis is a type of rigid foot orthosis that was designed to aid in controlling high degrees of foot pronation. It is essential to administer patients foot orthoses with different inverted angles, with higher angles prescribed when greater reduction of foot pronation is indicated. However, there is shortage of clinical knowledge regarding the inverted angle in terms of biomechanical changes. The aim of this study is to investigate the effect of different inverted angles of foot orthoses on the walking kinematics in females with flexible flatfeet.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females\n* Within the age group of 18-35 years\n* Asymptomatic flexible flatfeet\n* Resting Calcaneal Stance Position angle of ≥ 4° in valgus in both feet (bilateral)\n\nExclusion Criteria:\n\n* Previous surgery of the lower limbs or spine that might affect the performance of the study procedures\n* Any severe medical or musculoskeletal conditions that may have affected the lower limbs\n* Fixed flatfoot deformity\n* Leg length discrepancy (\\> 1cm)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05316051', 'briefTitle': 'Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet', 'organization': {'class': 'OTHER', 'fullName': 'University of Sharjah'}, 'officialTitle': 'Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet', 'orgStudyIdInfo': {'id': 'u20105881'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '25° inverted angle foot orthoses', 'interventionNames': ['Device: Inverted foot orthoses']}, {'type': 'EXPERIMENTAL', 'label': '15° inverted angle foot orthoses', 'interventionNames': ['Device: Inverted foot orthoses']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Inverted foot orthoses', 'type': 'DEVICE', 'description': 'Inverted functional orthoses will be used in this study based on Blake (1986) inverted orthotic technique. Two groups of foot orthosis will be fabricated with two different inverted angles: 25° inverted angle and 15° inverted angle.', 'armGroupLabels': ['15° inverted angle foot orthoses', '25° inverted angle foot orthoses']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sharjah city', 'country': 'United Arab Emirates', 'facility': 'University of Sharjah', 'geoPoint': {'lat': 25.3342, 'lon': 55.41221}}], 'overallOfficials': [{'name': 'Fatma A. Hegazy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sharjah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nour Mustafaalsaafin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Student', 'investigatorFullName': 'Nour Mustafaalsaafin', 'investigatorAffiliation': 'University of Sharjah'}}}}