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

NCT03812822 | Completed

• 1 other identifier: 2018/376
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Femoral Anteversion; Pes Planovalgus; Flat Foot

Keywords

Femoral anteversion, flat foot, insole, gait

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Insole Group

EXPERIMENTAL

Gait and foot posture analysis with and without the insole.

Device: Insole

Control Group

NO INTERVENTION

Gait and foot posture analysis.

Interventions

Insole DEVICE

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

Insole Group

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Neurological and / or musculoskeletal problems, Orthopedic problems to prevent walking.

Sponsors & Collaborators

• Istanbul Kültür University: lead

Study Sites (2)

İstanbul Kültür Üniversitesi

Istanbul, Turkey (Türkiye)

Location

İstanbul University, Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Clubfoot; Flatfoot

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Halenur Evrendilek, GRAD ASST

  İstanbul Kültür University

  STUDY CHAIR

• Ekin Akalan, PROF

  İstanbul Kültür University

  STUDY DIRECTOR

• Miray Budak, ASST PROF

  İstanbul Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 23, 2019
• Study Start: February 1, 2019
• Primary Completion: December 24, 2019
• Study Completion: December 24, 2019
• Last Updated: March 13, 2020

Record last verified: 2019-01

Locations

TU (2)