- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06548750
Foot Muscle Strengthening Exercises for Pes Planovalgus
Intrinsic vs Combined Foot Muscle Strengthening for Pes Planovalgus in Preschoolers: A Randomized Controlled Trial
Pes planovalgus is a common foot condition affecting the child population. It is characterized by the partial or complete collapse of the medial longitudinal arch with rearfoot eversion and forefoot abduction, which is associated with changes in lower extremity kinematics during dynamic activity.
The lower extremity chain includes the foot, ankle, knee, and hip joints, with the feet acting as the base of support. However, due to their small size, maintaining balance can be challenging. Any small dynamic change in the foot, as the support base, can impact overall body posture. The foot arch, which can be pronated or supinated, affects proprioceptive input by altering joint movement, contact area, and muscle strategy for stability. Pes planovalgus, characterized by excessive subtalar pronation, lead to instability and hypermobility, requiring more neuromuscular control to maintain balance. As a result, flat feet can cause pathomechanical issues and compensatory actions in the lower extremity chain, affecting overall body balance.
The effectiveness of exercise interventions, particularly foot intrinsic muscle strengthening exercises, in increasing the medial longitudinal arch in individuals with pes planus has been investigated in numerous studies. It is widely accepted that both intrinsic and extrinsic muscle groups play a crucial role in the formation, maintenance, and enhancement of foot arches. However, there is a lack of studies specifically examining the effectiveness of exercises aimed at strengthening these muscles in children with pes planovalgus. Therefore, the purpose of this study is to compare the effects of two corrective exercise programs focused on the improvement of the medial longitudinal arch in children with pes planovalgus: one incorporating routine intrinsic muscle exercises and the other combining them with extrinsic muscle exercises.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34093
- Bezmialem Vakif University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of bilateral pes planovalgus,
- Being between 4-7 years of age,
- Having a body mass index within normal limits
Exclusion Criteria:
- Having high femoral anteversion, internal tibial torsion and metatarsus adductus
- Having leg length inequality
- Having any neurological, rheumatic, musculoskeletal, metabolic and connective tissue disease
- Having a history of pain, deformity or surgery related to the vertebral column and lower extremities
- Having a cognitive, mental or serious psychiatric disease
- Having been involved in any exercise program or sports activity in the last six months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
Individuals with a diagnosis of pes planovalgus who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 1 day a week.
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Intrinsic and extrinsic muscle strengthening exercises
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Active Comparator: Control Group
Individuals with a diagnosis of pes planovalgus who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 1 day a week.
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Intrinsic muscle strengthening exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Single Leg Stance Test
Time Frame: change from baseline balance at 2 months
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It evaluates the participants' standing balance.
The entire lower extremity will be positioned in full extension, while the other side will be positioned in 90 degree flexion of the lower extremity hip and knee.
The time will be started when the participants' eyes are closed and the untested feet lose contact with the ground, and the time will be stopped when they put their feet back on the ground or when their body sway increases too much.
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change from baseline balance at 2 months
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Timed-up and Go Test
Time Frame: change from baseline balance at 2 months
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TUG is a measure of dynamic balance and the risk of falling.
It entails individuals rising from a chair, walking a distance of 3 feet, turning, and then sitting back down.
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change from baseline balance at 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Range of Motion
Time Frame: 2 times for 8 weeks
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For goniometric measurement, the pivot point will be placed on the lateral malleolus.
The fixed arm will be held parallel to the lateral midline of the fibula.
The mobile arm will follow the lateral midline of the 5th metatarsal bone.
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2 times for 8 weeks
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Thomas Test
Time Frame: 2 times for 8 weeks
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The Thomas Test will be used to determine the shortness of the hip flexors.
The Thomas test is performed with the patient in the supine position with the gluteal folds on the short side of the stretcher.
The untested side lower extremity is pulled towards the abdomen by performing hip-knee flexion; the tested side extremity is checked to see if it is separated from the stretcher.
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2 times for 8 weeks
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Duncan-Ely Test
Time Frame: 2 times for 8 weeks
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The Duncan-Ely test will be used to assess rectus femoris spasticity and shortness.
In this test, the patient will be asked to lie in a prone position.
The physiotherapist will attempt to quickly and passively bring the patient's knee joint on the side being assessed into full flexion.
If the heel cannot touch the hip or the hip on the side being tested lifts off the stretcher, the test is considered positive.
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2 times for 8 weeks
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Popliteal Angle Assessment
Time Frame: 2 times for 8 weeks
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It will be used to detect hamstring shortness.
The patient will be in the supine position, the tested side hip-knee will be flexed to 90°, and then passive extension will be applied to the knee.
Goniometric measurement will be made when the end-feel is felt in the patient's knee joint.
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2 times for 8 weeks
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Navicular Drop Test (NDT)
Time Frame: 2 times for 8 weeks
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It is one of the static foot assessment tools and represents the sagittal plane displacement of the navicular tuberosity in a neutral position.
If the NDT is below 5 mm, the foot is in supination; if it is between 6-8 mm, the foot is neutral; and if it is above 9 mm, the foot is in pronation.
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2 times for 8 weeks
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Foot Posture Index-6 (FPI-6)
Time Frame: 2 times for 8 weeks
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FPI-6, which is a simple, fast and reliable method applicable to pediatric feet, defines the static postural analysis of the foot when equal load is applied to both feet during standing.
Scores of 0-5 define normal foot; 6-9 define pes planovalgus and 10-12 define advanced pes planovalgus.
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2 times for 8 weeks
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6-minutes Walking Test
Time Frame: 2 times for 8 weeks
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It is a useful test to assess functional exercise capacity.
Patients are asked to walk as fast as they can down a straight 30-meter corridor for six minutes.
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2 times for 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Deniz Tuncer, PhD, Bezmialem Vakif University
Publications and helpful links
General Publications
- Moon DC, Kim K, Lee SK. Immediate Effect of Short-foot Exercise on Dynamic Balance of Subjects with Excessively Pronated Feet. J Phys Ther Sci. 2014 Jan;26(1):117-9. doi: 10.1589/jpts.26.117. Epub 2014 Feb 6.
- Pabon-Carrasco M, Castro-Mendez A, Vilar-Palomo S, Jimenez-Cebrian AM, Garcia-Paya I, Palomo-Toucedo IC. Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation. Int J Environ Res Public Health. 2020 Jul 7;17(13):4882. doi: 10.3390/ijerph17134882.
- Haun C, Brown CN, Hannigan K, Johnson ST. The Effects of the Short Foot Exercise on Navicular Drop: A Critically Appraised Topic. J Sport Rehabil. 2020 May 8;30(1):152-157. doi: 10.1123/jsr.2019-0437.
- Huang C, Chen LY, Liao YH, Masodsai K, Lin YY. Effects of the Short-Foot Exercise on Foot Alignment and Muscle Hypertrophy in Flatfoot Individuals: A Meta-Analysis. Int J Environ Res Public Health. 2022 Sep 22;19(19):11994. doi: 10.3390/ijerph191911994.
- Okamura K, Fukuda K, Oki S, Ono T, Tanaka S, Kanai S. Effects of plantar intrinsic foot muscle strengthening exercise on static and dynamic foot kinematics: A pilot randomized controlled single-blind trial in individuals with pes planus. Gait Posture. 2020 Jan;75:40-45. doi: 10.1016/j.gaitpost.2019.09.030. Epub 2019 Sep 29.
- Hara S, Kitano M, Kudo S. The effects of short foot exercises to treat flat foot deformity: A systematic review. J Back Musculoskelet Rehabil. 2023;36(1):21-33. doi: 10.3233/BMR-210374.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DT2024-AE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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