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

Flat Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812822
• Other study ID #: 2018/376
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 24, 2019

Study information

• Verified date: January 2019
• Source: Istanbul Kültür University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 24, 2019
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

Inclusion Criteria:

• Insole Group Between the ages 7-15, Trochanteric Prominens Angle Test > 20°, Hip internal rotation angle > 60°, 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 < 20°, Foot Posture Index score < 5, Without any neurologic or orthopedic disease

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Femoral Anteversion
• Flat Foot
• Flatfoot
• Pes Planovalgus

Intervention

Device:
• Insole
Custom-made insoles which support the foot at subtalar neutral position

Locations

Country	Name	City	State
Turkey	Istanbul Kültür Üniversitesi	Istanbul
Turkey	Istanbul University, Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Kültür University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Analysis	Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans)	Day 1
Primary	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