Describing the Effects of Insoles in Children With Increased Femoral Anteversion and Pes Planovalgus

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Effects of Using Insoles on Walking in Children With Increased Femoral Anteversion and Pes Planovalgus

Conditions
-----------------
Femoral Anteversion, Pes Planovalgus, Flat Foot

Intervention / Treatment
-----------------
* Device: Insole


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insole Group<br>Gait and foot posture analysis with and without the insole. | Device: Insole<br>* Custom-made insoles which support the foot at subtalar neutral position<br>|
| No Intervention: Control Group<br>Gait and foot posture analysis. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Analysis | Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans) | Day 1 | 
| Static Foot Posture Assesment | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral anteversion, flat foot, insole, gait