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Completed

NCT Number: NCT03812822

Describing the Effects of Insoles 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.

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Kültür Üniversitesi, Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insole

Device

Custom-made insoles which support the foot at subtalar neutral position

Primary outcomes

  1. Gait Analysis

    Time frame: Day 1

    Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans)

  2. 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)

Sponsors and collaborators

Lead sponsor

Istanbul Kültür University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2019
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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