Pes PlanusNCT06548750
Foot Muscle Strengthening Exercises for Pes Planovalgus
A study testing Intrinsic and Ectrinsic Exercise and Intrinsic Exercise in people with Pes Planus, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Intrinsic and Ectrinsic Exercise and Intrinsic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2024to 5 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of bilateral pes planovalgus,
- Being between 4-7 years of age,
- Having a body mass index within normal limits
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Voluntary children who have been diagnosed with pes planovalgus will be included in the study. Signed voluntary consent will be obtained from caregivers. Participants will be divided into two groups. Study groups will be as follows: a) Intervention Group (Intrinsic\&Extrinsic Exercise), b) Control Group (Intrinsic Exercise).
- Conditions
- Pes Planus
- Being tested
- Intrinsic and Ectrinsic Exercise, Intrinsic Exercise
- Keywords
- Intrinsic foot muscle, Physiotherapy, Foot core, Flat foot, Extinsic foot muscle
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrinsic and Ectrinsic ExerciseOther
Intrinsic and extrinsic muscle strengthening exercises
Intrinsic ExerciseOther
Intrinsic muscle strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Individuals with a diagnosis of pes planovalgus who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 1 day a week. Receives: Other: Intrinsic and Ectrinsic Exercise |
| Control Group | Active comparator | Individuals with a diagnosis of pes planovalgus who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 1 day a week. Receives: Other: Intrinsic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Leg Stance Test
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.
Measured: change from baseline balance at 2 months
Timed-up and Go Test
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.
Measured: change from baseline balance at 2 months
Secondary outcomes (7)
Range of Motion
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.
Measured: 2 times for 8 weeks
Thomas Test
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.
Measured: 2 times for 8 weeks
Duncan-Ely Test
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.
Measured: 2 times for 8 weeks
Popliteal Angle Assessment
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.
Measured: 2 times for 8 weeks
Navicular Drop Test (NDT)
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.
Measured: 2 times for 8 weeks
Foot Posture Index-6 (FPI-6)
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.
Measured: 2 times for 8 weeks
6-minutes Walking Test
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.
Measured: 2 times for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start2 Sep 2024
- Primary completion15 Jan 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be an equal number of participants in the two groups randomized by the computer
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Erekdag, Bezmialem Vakif University
- Investigators
- Deniz Tuncer, PhD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548750
- Sponsor's protocol ID
- DT2024-AE
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36231295Hara 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.
PubMed 35871320Okamura 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.
PubMed 31590069Pabon-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.
PubMed 32645830Haun 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.
PubMed 32384261Moon 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.
PubMed 24567688Tuncer D, Erekdag A, Senaran H, Uzer G. Intrinsic vs. combined foot muscle strengthening for pes planovalgus in children aged 4-7 years: a randomized controlled trial. Eur J Pediatr. 2025 Sep 25;184(10):636. doi: 10.1007/s00431-025-06480-3.
PubMed 40999032
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrinsic vs Combined Foot Muscle Strengthening for Pes Planovalgus in Preschoolers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06548750
- Acronym / sponsor ID
- DT2024-AE
- Conditions
- Pes Planus
- Keywords
- Intrinsic foot muscle, Physiotherapy, Foot core, Flat foot, Extinsic foot muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Voluntary children who have been diagnosed with pes planovalgus will be included in the study. Signed voluntary consent will be obtained from caregivers. Participants will be divided into two groups. Study groups will be as follows: a) Intervention Group (Intrinsic\&Extrinsic Exercise), b) Control Group (Intrinsic Exercise).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- There will be an equal number of participants in the two groups randomized by the computer
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intrinsic and Ectrinsic ExerciseIndividuals with a diagnosis of pes planovalgus who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 1 day a week. |
| Control Group | Active comparator | Other: Intrinsic ExerciseIndividuals with a diagnosis of pes planovalgus who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 1 day a week. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Presence of bilateral pes planovalgus,
- Being between 4-7 years of age,
- Having a body mass index within normal limits
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrinsic and Ectrinsic ExerciseIntrinsic and extrinsic muscle strengthening exercises | Other | Intervention Group |
| Intrinsic ExerciseIntrinsic muscle strengthening exercises | Other | Control Group |
Primary outcome
Single Leg Stance Test
Time frame: change from baseline balance at 2 months
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.
Timed-up and Go Test
Time frame: change from baseline balance at 2 months
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.
7 secondary outcomes
Range of Motion
Time frame: 2 times for 8 weeks
Thomas Test
Time frame: 2 times for 8 weeks
Duncan-Ely Test
Time frame: 2 times for 8 weeks
Popliteal Angle Assessment
Time frame: 2 times for 8 weeks
Navicular Drop Test (NDT)
Time frame: 2 times for 8 weeks
Foot Posture Index-6 (FPI-6)
Time frame: 2 times for 8 weeks
6-minutes Walking Test
Time frame: 2 times for 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 36231295Huang 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.
- Background: PubMed 35871320Hara 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.
- Background: PubMed 31590069Okamura 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.
- Background: PubMed 32645830Pabon-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.
- Background: PubMed 32384261Haun 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.
- Background: PubMed 24567688Moon 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.
- Derived from this study: PubMed 40999032Tuncer D, Erekdag A, Senaran H, Uzer G. Intrinsic vs. combined foot muscle strengthening for pes planovalgus in children aged 4-7 years: a randomized controlled trial. Eur J Pediatr. 2025 Sep 25;184(10):636. doi: 10.1007/s00431-025-06480-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Tuncer, PhD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrinsic and Ectrinsic Exercise and Intrinsic Exercise in people with Pes Planus, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Leg Stance Test (time frame: change from baseline balance at 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06548750, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.