NCT06548750

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

September 2, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 8, 2024

Last Update Submit

August 8, 2025

Conditions

Keywords

Intrinsic foot musclePhysiotherapyFoot coreFlat footExtinsic foot muscle

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    change from baseline balance at 2 months

Secondary Outcomes (7)

  • Range of Motion

    2 times for 8 weeks

  • Thomas Test

    2 times for 8 weeks

  • Duncan-Ely Test

    2 times for 8 weeks

  • Popliteal Angle Assessment

    2 times for 8 weeks

  • Navicular Drop Test (NDT)

    2 times for 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Other: Intrinsic Exercise

Interventions

Intrinsic and extrinsic muscle strengthening exercises

Intervention Group

Intrinsic muscle strengthening exercises

Control Group

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Presence of bilateral pes planovalgus,
  • Being between 4-7 years of age,
  • Having a body mass index within normal limits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 36231295BACKGROUND
  • 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.

    PMID: 35871320BACKGROUND
  • 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.

    PMID: 31590069BACKGROUND
  • 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.

    PMID: 32645830BACKGROUND
  • 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.

    PMID: 32384261BACKGROUND
  • 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.

    PMID: 24567688BACKGROUND
  • Tuncer 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.

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Deniz Tuncer, PhD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The assessor will not know which participant received which intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be an equal number of participants in the two groups randomized by the computer
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 12, 2024

Study Start

September 2, 2024

Primary Completion

January 15, 2025

Study Completion

February 5, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations