Describing the Effects of Insoles in Children With Increased Femoral Anteversion and Pes Planovalgus
Primary Purpose
Femoral Anteversion, Pes Planovalgus, Flat Foot
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Insole
Sponsored by
About this trial
This is an interventional supportive care trial for Femoral Anteversion focused on measuring Femoral anteversion, flat foot, insole, gait
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.
Sites / Locations
- İstanbul Kültür Üniversitesi
- İstanbul University, Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Insole Group
Control Group
Arm Description
Gait and foot posture analysis with and without the insole.
Gait and foot posture analysis.
Outcomes
Primary Outcome Measures
Gait Analysis
Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03812822
First Posted
January 17, 2019
Last Updated
March 12, 2020
Sponsor
Istanbul Kültür University
1. Study Identification
Unique Protocol Identification Number
NCT03812822
Brief Title
Describing the Effects of Insoles in Children With Increased Femoral Anteversion and Pes Planovalgus
Official Title
The Effects of Using Insoles on Walking in Children With Increased Femoral Anteversion and Pes Planovalgus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
December 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Kültür University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Anteversion, Pes Planovalgus, Flat Foot
Keywords
Femoral anteversion, flat foot, insole, gait
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insole Group
Arm Type
Experimental
Arm Description
Gait and foot posture analysis with and without the insole.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Gait and foot posture analysis.
Intervention Type
Device
Intervention Name(s)
Insole
Intervention Description
Custom-made insoles which support the foot at subtalar neutral position
Primary Outcome Measure Information:
Title
Gait Analysis
Description
Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans)
Time Frame
Day 1
Title
Static Foot Posture Assesment
Description
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)
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halenur Evrendilek, GRAD ASST
Organizational Affiliation
İstanbul Kültür University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ekin Akalan, PROF
Organizational Affiliation
İstanbul Kültür University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Miray Budak, ASST PROF
Organizational Affiliation
İstanbul Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
İstanbul Kültür Üniversitesi
City
Istanbul
Country
Turkey
Facility Name
İstanbul University, Faculty of Medicine
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Describing the Effects of Insoles in Children With Increased Femoral Anteversion and Pes Planovalgus
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