NCT07123753

Brief Summary

Pes planus is a musculoskeletal syndrome in which the medial longitudinal arch (MLA) of the foot is reduced or flattened. It results from a combination of static and dynamic abnormalities. Various predisposing factors such as increased weight, foot injury, and musculoskeletal disorders are associated with this problem. In addition, studies have emphasized that there is a significant relationship between abnormal foot posture and gait mechanics.

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 Feb 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

March 12, 2025

Last Update Submit

February 9, 2026

Conditions

Keywords

Adolescent, foot core exercise, foot classic exercise, pes planus

Outcome Measures

Primary Outcomes (6)

  • The navicular drop test

    The navicular drop test is a test used in the clinic to determine the presence and degree of pes planus. It will be used to distinguish participants with and without pes planus.). In this test, first the navicular tubercle is palpated and marked, and the distance between the navicular tubercle and the floor is measured with a ruler while the person is in a sitting position and the feet are only in contact with the floor (without putting weight on the feet). Then the person stands up and puts equal weight on their feet, and the distance between the navicular tubercle and the floor is measured again. Measurements are made bilaterally and recorded in millimeters (mm) or centimeters (cm). In the navicular drop test, the difference between the weighted and unweighted measurements is considered normal (neutral) between 5-9 mm, excessive pronation of 10 mm and above, and excessive supination of 4 mm and below.

    Change from Baseline at 8 weeks

  • STAR BALANCE TEST

    Star balance test (SBT) is one of the tests frequently used to evaluate lower extremity dynamic balance and postural control. SBT is a test that measures the maximum extension an individual can achieve by maintaining balance and performing a single-leg squat on lines drawn at 45-degree intervals in eight different directions.

    Change from Baseline at 8 weeks

  • The foot function index

    The foot function index is a test used to determine pain, disability and activity limitation. It is a scale consisting of a total of three parameters and 23 items. The pain subscale contains nine items and measures the severity of foot pain in different situations. The disability subscale contains 9 items and evaluates the severity of the difficulty in performing functional activities due to the person's foot problems. The activity limitation subscale contains 5 items and measures the person's activity limitations due to foot problems. The AFI is a scale filled out by the person himself. A high score indicates more pain, disability and activity limitation.

    Change from Baseline at 8 weeks

  • Gait Assessment (Footprint method):

    Gait Assessment (Footprint method): General gait parameters are temporal and distance factors, cycle time (cadence), step length and speed. These are the simplest form of objective gait assessment. Only a stopwatch, a tape measure and some talcum powder are required. The individual will be asked to walk naturally and will be allowed to stand on their own feet. The individual will step on a tray of talcum powder and then will be asked to walk across a black bag. The left and right step lengths, step length, toe angle and an idea of the foot contact pattern are obtained.

    Change from Baseline at 8 weeks

  • Dynamic Gait Index

    The Dynamic Gait Index (DGI) is a clinical measure that assesses the ability of a person to adapt to complex walking tasks commonly encountered in daily life. The DGI is based on a person-environment mobility disability model in which environmental demands are categorized as distance, time, environment, terrain, physical load, attention, postural transitions, and intensity, and represents the external demand that must be met for an individual to move in a given environment. Item 1 of the DGI is considered the reference or baseline task and examines the ability to walk under low-intensity conditions (self-paced, level-surface walking). The remaining 7 items examine the person's ability to adapt their gait to task demands in 4 environmental dimensions.Each item is scored on an ordinal scale (0-3) based on gait pattern, speed, and assistance level, with total scores ranging from 0 (worst) to 24 (best)."

    Change from Baseline at 8 weeks

  • Functional Muscle Strength Evaluation

    Functional Muscle Strength Evaluation: The number of repetitions of the movement in a certain period of time is a valid and reliable method used effectively in functional muscle strength evaluation. In our study, individuals' lower extremity functional muscle strength will be evaluated with a 30-second maximum repetition test. Within the scope of this evaluation, individuals are asked to perform 3 closed kinetic chain exercises involving large muscle groups for standing and walking. These are (1) "Lateral Step-up" test (taking a side step to a 20 cm bench), (2) "Sitto-Stand" test (standing up without sitting without using the arms), (3) "Attain Stand Through Half Knee" (moving from kneeling position to half kneeling position) test. The maximum number of repetitions the person does in 30 seconds is noted. A higher number of repetitions indicates better functional performance.

    Change from Baseline at 8 weeks

Study Arms (2)

CONTROL

ACTIVE COMPARATOR

CLASSIC FOOT EXERCISE WILL BE APPLIED

Other: EXERCİSE

WORKING GROUP

ACTIVE COMPARATOR

CORE FOOT EXERCISE WILL BE APPLIED

Other: EXERCİSE

Interventions

The aim of this study is to examine the effects of classical foot exercises and foot core exercises on pain, balance, gait and lower extremity performance in adolescents with pes planus. This study is planned to be a randomized controlled trial. Participants will be randomly divided into 2 groups. Classic foot exercises will be applied to individuals in the classical foot exercises group for 12-15 minutes, and foot core exercises will be applied to individuals in the core exercises group for 12-15 minutes twice a week for a total of 8 weeks. Pes planus status of individuals included in the study will be evaluated with the navicular drop test. Pain will be evaluated with the foot function test, balance with the star balance test, gait analysis with the footprint method and lower extremity muscle performance with the functional muscle strength assessment for individuals in both groups before and after the application. The evaluations will be applied face to face by the same physiotherapi

CONTROLWORKING GROUP

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Those who have not had any surgery in the last 6 months
  • Individuals who do not have any physical or mental disabilities
  • Individuals who volunteer to participate in the study

You may not qualify if:

  • Individuals with major foot deformities other than pes planus Individuals with any physical or mental disability Individuals with a history of lower extremity injury in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Islam Science and Technology University

Gaziantep, Nizip, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Flatfoot

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 12, 2025

First Posted

August 14, 2025

Study Start

February 2, 2025

Primary Completion

February 2, 2026

Study Completion

February 5, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations