- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03812822
Describing the Effects of Insoles in Children With Increased Femoral Anteversion and Pes Planovalgus
The Effects of Using Insoles on Walking in Children With Increased Femoral Anteversion and Pes Planovalgus
Increased Femoral Anteversion is a transverse plan problem that affects lower body alignment, walking and standing characteristics and also pes planovalgus mostly accompanies with IFA. It is shown that children with IFA and PPV have back and leg pain, fatigue, muscle cramps and they are under the risk for chronic disorders such as osteoarthritis, scoliosis and muscle injuries.
Insoles, which reduce pronation of foot (flat foot), provide apparently a static correction by supporting proper alignment in children with IFA and PPV. However, the dynamic effects of insoles to lower extremity biomechanics while walking is not known.
The aims of this study are to determine the effects of the insoles on walking biomechanics in children with IFA and PPV by comparing with their healthy peers.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- İstanbul Kültür Üniversitesi
-
Istanbul, Turkey
- Istanbul University, Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Insole Group Between the ages 7-15, Trochanteric Prominens Angle Test > 20⁰, Hip internal rotation angle > 60⁰, Without insole Foot Posture Index score > 5, With insole Foot Posture Index score > 4, Using their insoles' at least one month.
- Control Group Between the ages 7-15, Trochanteric Prominens Angle Test < 20⁰, Foot Posture Index score < 5, Without any neurologic or orthopedic disease
Exclusion Criteria:
Neurological and / or musculoskeletal problems, Orthopedic problems to prevent walking.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Insole Group
Gait and foot posture analysis with and without the insole.
|
Custom-made insoles which support the foot at subtalar neutral position
|
No Intervention: Control Group
Gait and foot posture analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait Analysis
Time Frame: Day 1
|
Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans)
|
Day 1
|
Static Foot Posture Assesment
Time Frame: Day 1
|
Foot Posture Index - 6 6 items ( 1.talar head palpation, 2.supra and infra lateral malleolar curvature,3.calcaneal
frontal plane position, 4.prominence in the region of the talonavicular joint, 5.congruence of the medial longitudinal arch, and 6.abduction/adduction of the forefoot on the rearfoot)
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Halenur Evrendilek, GRAD ASST, Istanbul Kültür University
- Study Director: Ekin Akalan, PROF, Istanbul Kültür University
- Study Director: Miray Budak, ASST PROF, Istanbul Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/376
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Flat Foot
-
Hacettepe UniversityEnrolling by invitationSpinal Curvatures | Flat Foot [Pes Planus] (Acquired), Left Foot | Flat Foot [Pes Planus] (Acquired), Right Foot | Flat Foot Acquired Bilateral (Pes Planus) | Pelvic ObliquityTurkey
-
Assiut UniversityUnknownFlat Foot; Rigid | Flat Foot; Spastic
-
University of ExtremaduraCompleted
-
Istituto Ortopedico RizzoliRecruitingFlat Feet | Subtalar Arthrorisis | Growth AgeItaly
-
Istituto Ortopedico RizzoliCompletedSurgery | Sports Physical Therapy | Flat FeetItaly
-
TOPMEDNatural Sciences and Engineering Research Council, Canada; Cryos Technologies...Active, not recruitingFlat Feet | High Arched FootCanada
-
Mustafa Kemal UniversityRecruitingFlat Foot [Pes Planus] (Acquired), Unspecified FootTurkey
-
Abant Izzet Baysal UniversityCompletedFlat Foot [Pes Planus] (Acquired), Unspecified FootTurkey
-
Mahmoud Ali Hassan AbdelhamidNot yet recruitingTreatment Of Symptomatic Pes Planus By Sinus Tarsi Screw Versus Conical Subtalar Screw ArthroereisisSymptomatic Flexible Flat Feet
Clinical Trials on Insole
-
Staffordshire UniversityKing's College Hospital NHS TrustNot yet recruiting
-
Federal University of São PauloConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedMorton Neuroma
-
Reckitt Benckiser Healthcare (UK) LimitedSynteractHCR Deutschland GmbHTerminatedMusculoskeletal PainUnited Kingdom
-
Fondazione Don Carlo Gnocchi OnlusCompletedParkinson DiseaseItaly
-
Rush University Medical CenterArthritis FoundationCompleted
-
Taipei Medical University WanFang HospitalNot yet recruiting
-
China Medical University HospitalUnknown
-
Wilfrid Laurier UniversityCompletedAccidental FallsCanada
-
University of IowaFoundation for Physical Medicine and RehabilitationCompleted
-
Federal University of São PauloConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedChronic Nonspecific Low Back PainBrazil