NCT07764393

Brief Summary

The goal of this observational study is to explore how the shape of the foot arch affects muscle tone, strength, and balance in healthy young adults aged 18-25, of all genders. The main questions it aims to answer are:

  • Complete a sociodemographic questionnaire (Age, gender, physical activity level, dominant leg, and footwear habits), and anthropometric measurements (Height, weight, and BMI).
  • Undergo static balance test for both legs: Single Leg Stance, counting the errors made in 30 seconds for 3 trials. \- Undergo dynamic balance tests for both legs: Star Excursion Balance Test (SEBT) by reaching in 8 directions while balancing on one foot, and Single-Leg Hop for Distance by hopping forward on one leg.
  • Have muscle tone and stiffness assessed using the MyotonPRO device on specified lower limb muscles.
  • Have muscle strength measured using a handheld dynamometer (MicroFET2) across major specified leg muscles. People have different types of foot arches. Some have flat feet (pes planus), some have high arches (pes cavus), and others have normal arches. These variations affect how the body aligns during movement and balance. Flat feet may cause inward rolling (overpronation), fatigue, and pain. High arches may cause stiffness, poor shock absorption, and a higher risk of ankle injuries. Both arch types can reduce postural control and increase the risk of imbalance. Since lower body muscles are critical for maintaining posture, weak or poorly coordinated muscles can worsen these effects. However, no previous study has comprehensively explored the combination of foot arch structure, muscle tone, muscle strength, and both static and dynamic balance. This study aims to fill that gap. The results may help healthcare professionals develop better screening and treatment strategies, such as exercise programs, rehabilitation approaches, and shoe recommendations for individuals with flat or high arches. By understanding these factors, the investigators can improve movement efficiency, prevent injuries, and support better quality of life. All participants will be informed of the study procedures and will provide both written and verbal consent. The study will be conducted in compliance with ethical standards.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

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

Study Start

First participant enrolled

July 2, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

December 26, 2025

Last Update Submit

August 11, 2026

Conditions

Keywords

Pes CavusPes PlanusStatic BalanceDynamic BalanceFoot ArchMuscle ToneMuscle Strength

Outcome Measures

Primary Outcomes (7)

  • Lower Extremity Muscle Tone

    Muscle tone of the lower extremity will be measured using the MyotonPRO device, which provides non-invasive assessment of muscle biomechanical properties including tone, stiffness, and elasticity. Target muscles include the quadriceps, hamstrings, tibialis anterior, gastrocnemius, and peroneus longus.

    At baseline (single session)

  • Lower Extremity Muscle Strength

    Muscle strength will be assessed using a handheld dynamometer (MicroFET2) following Kendall's manual muscle testing positions. Participants will perform isolated maximal effort contractions for key lower limb muscles including the quadriceps, hamstrings, gastrocnemius, tibialis anterior, and toe flexors. The average value across 3 trials will be recorded in KgF.

    At baseline (single session)

  • Single Leg Stance (Static Balance)

    The Single Leg Stance (SLS) test assesses static balance by timing how long a person can stand on one leg (in seconds) without support or losing position. Arms are kept by the sides or on the hips, the non-stance leg is lifted, and the trial ends when the lifted foot touches down, the stance foot moves, or support is needed. It is quick, low-cost, and widely used in clinical trials to quantify balance and fall risk.

    At baseline (single session)

  • Star Excursion Balance Test (Dynamic Balance)

    The Star Excursion Balance Test is a dynamic balance assessment in where participant stands on one leg at the center of an 8-direction star and reaches as far as possible (measured in centimeters) along each line with the opposite foot while maintaining control and not shifting weight onto the reaching leg. Reach distances are usually normalized to leg length and averaged over multiple trials.

    At baseline (single session)

  • Height

    Standing height was measured using a flexible metal measure to the nearest 0.1cm

    At baseline (single session)

  • Weight

    Standing weight was measured using a calibrated digital scale to the nearest 0.1 kg

    At baseline (single session)

  • Body Mass Index (BMI)

    Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2.

    At baseline (single session)

Secondary Outcomes (2)

  • Effect of Gender on the outcomes

    At baseline (single session)

  • Leg Symmetry Index

    At baseline (single session)

Study Arms (3)

Pes Cavus

Diagnostic Test: Arch Height IndexDiagnostic Test: Foot Posture IndexDiagnostic Test: Single Leg StanceDiagnostic Test: Star Excrusion Blance Test (SEBT)Diagnostic Test: Single-Leg Hop for DistanceDiagnostic Test: Myometer DeviceDiagnostic Test: DynamometerOther: HeightOther: WeightOther: Body Mass Index

Pes Planus

Diagnostic Test: Arch Height IndexDiagnostic Test: Foot Posture IndexDiagnostic Test: Single Leg StanceDiagnostic Test: Star Excrusion Blance Test (SEBT)Diagnostic Test: Single-Leg Hop for DistanceDiagnostic Test: Myometer DeviceDiagnostic Test: DynamometerOther: HeightOther: WeightOther: Body Mass Index

Normal Foot Arch

Diagnostic Test: Arch Height IndexDiagnostic Test: Foot Posture IndexDiagnostic Test: Single Leg StanceDiagnostic Test: Star Excrusion Blance Test (SEBT)Diagnostic Test: Single-Leg Hop for DistanceDiagnostic Test: Myometer DeviceDiagnostic Test: DynamometerOther: HeightOther: WeightOther: Body Mass Index

Interventions

Arch Height IndexDIAGNOSTIC_TEST

The goal of this assessment is to objectively classify foot posture as low-arched, high-arched, or normal using the Arch Height Index (AHI). Participants will sit with hips and knees at 90°, feet lightly weight-bearing (\~10%), and measurements will be taken with a caliper and paper. AHI is calculated as arch height at 50% of total foot length divided by truncated foot length. Feet with a ratio ≥ 0.356 are classified as high-arched, ≤ 0.275 as low-arched, and 0.276-0.355 as normal. Both feet will be assessed, focusing on the medial longitudinal arch. AHI demonstrates excellent inter-rater and test-retest reliability (ICC = 0.98-1.00).

Normal Foot ArchPes CavusPes Planus
Foot Posture IndexDIAGNOSTIC_TEST

The participant will be asked to stand still with arms along the side, looking forward and their feet will be assessed according to the index components while being observed by the physiotherapist. Scores between 0 and+5 indicate normal feet; +6 to+9 indicate pronated feet; ≥ +10 indicate highly pronated feet;-1 to-4 indicate supinated feet;-5 to-12 indicate highly supinated feet. The goal of this assessment is to help classifying the participants' foot arch. High inter-rater and test-retest reliability for FPI scoring (ICC values of 0.923 and 0.931).

Normal Foot ArchPes CavusPes Planus
Single Leg StanceDIAGNOSTIC_TEST

Static balance will be assessed using the Single Leg Stance (SLS) test. Participants will stand barefoot on one leg with arms along the sides and the non-stance foot lifted clear of the ground. Timing begins when the foot is lifted and ends when balance is lost, defined as placement of the lifted foot, movement of the stance foot, or grasping for support. Each leg will be assessed for a maximum of 30 seconds over three trials, and the mean value will be used for analysis. Longer durations indicate better static postural control. The test will be performed under eyes-open conditions. The SLS test has demonstrated good to excellent test-retest reliability in healthy adults, with ICC values ranging from 0.79 to 0.95, and has shown acceptable reliability and predictive validity for balance assessment in clinical settings.

Normal Foot ArchPes CavusPes Planus

Participants will perform the Star Excursion Balance Test (SEBT) barefoot, standing on one leg at the center of a star-shaped layout with 8 directions: ANT, AM, M, PM, P, PL, L, and AL, each at 45° angles. With hands on hips to reduce arm compensation, they will reach in each direction using the opposite leg without shifting weight or losing balance. Reach distance will be marked and trials repeated if form is compromised. Three trials per leg will be completed with 2-minute rests to reduce fatigue. Reach distances will be normalized to leg length (ASIS to medial or lateral malleolus) to ensure fair comparison. The SEBT assesses dynamic balance and has shown good reliability (ICC = 0.75-0.9).

Normal Foot ArchPes CavusPes Planus

The participant will be asked to assume a single-leg stance behind a marked starting line and will be instructed to hop forward as far as possible using a single explosive movement. They must land on the same leg while maintaining stability for at least 2-3 seconds. If the participant loses balance, touches the ground with the other foot, or falls forward, the attempt is not counted. Each participant will perform 3 trials per leg, with a rest period of 30-60 seconds between trials. The longest valid hop distance is recorded for each leg to calculate Leg Symmetry Index. The goal of single-leg hop for distance is to assess the dynamic balance, and it has excellent ICC values for test-retest reliability exceeded 0.86.

Normal Foot ArchPes CavusPes Planus
Myometer DeviceDIAGNOSTIC_TEST

Muscle tone, stiffness, and elasticity will be measured using the MyotonPRO device, a non-invasive tool for evaluating muscle biomechanical properties. Participants will assume standardized positions, and measurements will be taken from the broadest cross-sectional area of the following muscles: M. Peroneus Longus, M. Tibialis Anterior, M. Gastrocnemius, Quadriceps (Vastus Medialis, Rectus Femoris, Vastus Lateralis), and Hamstrings (Biceps Femoris, Semitendinosus). The probe will be placed perpendicular to the skin. Five parameters will be recorded: frequency, stiffness, decrement, mechanical stress relaxation time, and creep. The method demonstrates high intra-rater (ICC = 0.63-0.99) and inter-rater (ICC = 0.63-0.97) reliability for lower limb muscles.

Normal Foot ArchPes CavusPes Planus
DynamometerDIAGNOSTIC_TEST

Muscle strength will be assessed using a handheld dynamometer (HOGGAN MICROFET2), following the manual muscle testing protocols outlined by Kendall. Target muscles include: M. Peroneus Longus, M. Tibialis Anterior, M. Gastrocnemius, Quadriceps, Hamstrings, M. Extensor Hallucis Longus, and Toe Flexors (M. Flexor Hallucis Brevis and M. Flexor Digitorum Brevis). Participants will perform isolated muscle actions against the device at standardized joint angles. Each test will be repeated for 3 trials, with average values recorded. This method effectively detects muscle imbalances and strength changes, and shows high reliability (ICCs often \> 0.9), strong validity versus isokinetic dynamometers, and an MCIT of \~0.58-17.2 N.

Normal Foot ArchPes CavusPes Planus
HeightOTHER

Standing height was measured using a flexible metal measure to the nearest 0.1 cm

Normal Foot ArchPes CavusPes Planus
WeightOTHER

Body weight was measured using a calibrated digital scale to the nearest 0.1 kg.

Normal Foot ArchPes CavusPes Planus

Body mass index (BMI) was calculated as weight (kg) divided by height squared (m²) .

Normal Foot ArchPes CavusPes Planus

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

young adults

You may qualify if:

  • Aged 18-25 years old-
  • Not diagnosed with other medical conditions, fractures, or deformities
  • No prior foot or lower limb surgeries affecting musculoskeletal health
  • Wears sport shoes majority of the time

You may not qualify if:

  • Neurological Disorders: Conditions affecting balance or muscle tone
  • Balance Disorders like vestibular or inner ear conditions
  • Women that wears high heels majority of the time
  • Men that wear stiff and hard material shoes majority of the time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fizyoterapi ve Rehabilitasyon Uygulama ve Araştırma Merkezi (İSÜFİZYOTEM).

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (31)

  • Jackson SM, Cheng MS, Smith AR Jr, Kolber MJ. Intrarater reliability of hand held dynamometry in measuring lower extremity isometric strength using a portable stabilization device. Musculoskelet Sci Pract. 2017 Feb;27:137-141. doi: 10.1016/j.math.2016.07.010. Epub 2016 Jul 21.

  • Douma RK, Soer R, Krijnen WP, Reneman M, van der Schans CP. Reference values for isometric muscle force among workers for the Netherlands: a comparison of reference values. BMC Sports Sci Med Rehabil. 2014 Feb 25;6(1):10. doi: 10.1186/2052-1847-6-10.

  • Baron M, Divernois G, Grandjean B, Guex K. Validity and Reliability of Handheld Dynamometry to Assess Isometric Hamstrings and Quadriceps Strength at Varying Muscle Lengths. J Sport Rehabil. 2024 Apr 1;33(4):267-274. doi: 10.1123/jsr.2023-0256. Print 2024 May 1.

  • Matuszczyk, F., Trybulski, R., Gałęziok, K., Olaniszyn, G., Terbalyan, A., & Wilk, M. (2025). Effect of 10-Week Plyometric Training on Anaerobic Performance and Biomechanical Properties of the Muscles in Football Players: Randomized Controlled Trial. Applied Sciences, 15(3), 1451. https://doi.org/10.3390/app15031451.

    RESULT
  • Lettner J, Krolikowska A, Ramadanov N, Oleksy L, Hakam HT, Becker R, Prill R. Evaluating the Reliability of MyotonPro in Assessing Muscle Properties: A Systematic Review of Diagnostic Test Accuracy. Medicina (Kaunas). 2024 May 23;60(6):851. doi: 10.3390/medicina60060851.

  • Bąkowski, P., Cisowski, P., Rubczak, S., Wolff-Stefaniak, M., Bąkowska, A., & Piontek, T. (2017). Clinical functional assessment of patients after Achilles tendon percutaneous suture. Issue Rehabil Orthop Neurophysiol Sport Promot, 21, 19-29.

    RESULT
  • McManigal M, Post A, Allen M, Jorgensen A, Rosenthal M, Wellsandt M, Tao M, Wellsandt E. Reliability of Spatiotemporal Characteristics During Single-Legged Hop and Bilateral Drop Jump Tasks Using an Instrumented Pressure Walkway. Int J Sports Phys Ther. 2024 Jun 1;19(6):704-713. doi: 10.26603/001c.117401. eCollection 2024.

  • Pierobon A, Raguzzi I, Solino S, Salzberg S, Vuoto T, Gilgado D, Perez Calvo E. Minimal detectable change and reliability of the star excursion balance test in patients with lateral ankle sprain. Physiother Res Int. 2020 Oct;25(4):e1850. doi: 10.1002/pri.1850. Epub 2020 May 26.

  • Hebert-Losier K. Clinical Implications of Hand Position and Lower Limb Length Measurement Method on Y-Balance Test Scores and Interpretations. J Athl Train. 2017 Oct;52(10):910-917. doi: 10.4085/1062-6050-52.8.02. Epub 2017 Sep 22.

  • Amin, D. J., Coleman, J., & Herrington, L. C. (2014). The test-retest reliability and minimal detectable change of the balance error scoring system. J Sports Sci, 2, 200-7.

    RESULT
  • Bell DR, Guskiewicz KM, Clark MA, Padua DA. Systematic review of the balance error scoring system. Sports Health. 2011 May;3(3):287-95. doi: 10.1177/1941738111403122.

  • Muscat-Inglott, M. (2020). The Modified Flamingo Test: A Convenient Assessment of Balance for Planning Exercise Interventions with Older Adults. Social Science Research Network. https://doi.org/10.2139/ssrn.3594107.

    RESULT
  • Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.

  • Mazzotti, A., Arceri, A., Abdi, P., Artioli, E., Zielli, S. O., Langone, L., Ramponi, L., Ridolfi, A., Faldini, C., & Brognara, L. (2024). An Innovative Clinical Evaluation Protocol after Total Ankle Arthroplasty: A Pilot Study Using Inertial Sensors and Baropodometric Platforms. Applied Sciences, 14(5), 1964. https://doi.org/10.3390/app14051964.

    RESULT
  • Vico Pardo FJ, Lopez Del Amo A, Pardo Rios M, Gijon-Nogueron G, Yuste CC. Changes in foot posture during pregnancy and their relation with musculoskeletal pain: A longitudinal cohort study. Women Birth. 2018 Apr;31(2):e84-e88. doi: 10.1016/j.wombi.2017.08.114. Epub 2017 Sep 6.

  • Shen X, Wang S, Chen J, Li J, Li C, Xiang R, Zhao C, Xu X. Inter-rater reliability and test-retest reliability of the foot posture index (FPI-6) for assessing static foot posture in elderly female patients with knee osteoarthritis and its association with quadriceps muscle tone and stiffness. Front Bioeng Biotechnol. 2024 Jun 21;12:1385986. doi: 10.3389/fbioe.2024.1385986. eCollection 2024.

  • Yang J, Ou Z, Mao Z, Wang Y, Zhong Y, Dong W, Shen Z, Chen Z. Reliability and validity of Foot Posture Index (FPI-6) for evaluating foot posture in participants with low back pain. Sci Rep. 2022 Dec 7;12(1):21168. doi: 10.1038/s41598-022-22220-1.

  • Miller, E. E., Whitcome, K. K., Lieberman, D. E., Norton, H. L., & Dyer, R. E. (2014). The effect of minimal shoes on arch structure and intrinsic foot muscle strength. Journal of Sport and Health Science, 3(2), 74-85.

    RESULT
  • Xu J, Goss DD, Saliba SA. A Novel Intrinsic Foot Muscle Strength Dynamometer Demonstrates Moderate-To-Excellent Reliability and Validity. Int J Sports Phys Ther. 2023 Aug 1;18(4):997-1008. doi: 10.26603/001c.84310. eCollection 2023.

  • Drefus LC, Kedem P, Mangan SM, Scher DM, Hillstrom HJ. Reliability of the Arch Height Index as a Measure of Foot Structure in Children. Pediatr Phys Ther. 2017 Jan;29(1):83-88. doi: 10.1097/PEP.0000000000000337.

  • Cairns, C. I., Van Citters, D. W., & Chapman, R. M. (2024). The Relationship Between Foot Anthropometrics, Lower-Extremity Kinematics, and Ground Reaction Force in Elite Female Basketball Players: An Exploratory Study Investigating Arch Height Index and Navicular Drop. Biomechanics, 4(4), 750-764. https://doi.org/10.3390/biomechanics4040055.

    RESULT
  • Sahin FN, Ceylan L, Kucuk H, Ceylan T, Arikan G, Yigit S, Sarsik DC, Guler O. Examining the Relationship between Pes Planus Degree, Balance and Jump Performances in Athletes. Int J Environ Res Public Health. 2022 Sep 15;19(18):11602. doi: 10.3390/ijerph191811602.

  • Barutcu, E., Paksoy, B., Selçuk, M., Karaca, O., & Yilmaz, K. (2023). Effects of Pes Planus on Foot Pain, Low Back Pain and Balance in Young Adult Individuals. Acibadem Universitesi Saglik Bilimleri Dergisi. https://doi.org/10.31067/acusaglik.1329890.

    RESULT
  • Wei Z, Zeng Z, Liu M, Wang L. Effect of intrinsic foot muscles training on foot function and dynamic postural balance: A systematic review and meta-analysis. PLoS One. 2022 Apr 20;17(4):e0266525. doi: 10.1371/journal.pone.0266525. eCollection 2022.

  • Pfeifer LO, Botton CE, Diefenthaeler F, Umpierre D, Pinto RS. Effects of a power training program in the functional capacity, on body balance and lower limb muscle strength of elderly with type 2 diabetes mellitus. J Sports Med Phys Fitness. 2021 Nov;61(11):1529-1537. doi: 10.23736/S0022-4707.21.11880-8. Epub 2021 Jan 22.

  • Hill MW, Wdowski MM, Rosicka K, Kay AD, Muehlbauer T. Exploring the relationship of static and dynamic balance with muscle mechanical properties of the lower limbs in healthy young adults. Front Physiol. 2023 May 26;14:1168314. doi: 10.3389/fphys.2023.1168314. eCollection 2023.

  • Garcia-Bernal MI, Gonzalez-Garcia P, Madeleine P, Casuso-Holgado MJ, Heredia-Rizo AM. Characterization of the Structural and Mechanical Changes of the Biceps Brachii and Gastrocnemius Muscles in the Subacute and Chronic Stage after Stroke. Int J Environ Res Public Health. 2023 Jan 12;20(2):1405. doi: 10.3390/ijerph20021405.

  • Bazvand, M., Mosavi, S., Mi'mar, R., & Sadeghi, H. (2014). Dynamic Postural Comparison during Gait Analysis in Men with Pes Cavus and Pes Planus. Journal of Mazandaran University of Medical Sciences, 24, 161-171.

    RESULT
  • García, B. E. C., Reyes, B. F. P., Tenesaca, R. P. C., Rosas, E. D. R., Piedra, A. V. R., Cárdenas, P. A. C., & Ordoñez, D. W. F. THE PES CAVUS, SCOPING REVIEW.

    RESULT
  • Cen X, Song Y, Yu P, Sun D, Simon J, Biro I, Gu Y. Effects of plantar fascia stiffness on the internal mechanics of idiopathic pes cavus by finite element analysis: implications for metatarsalgia. Comput Methods Biomech Biomed Engin. 2024 Nov;27(14):1961-1969. doi: 10.1080/10255842.2023.2268231. Epub 2023 Oct 11.

  • Kalra S, A K D, Md F, K S, P S, A A R, M J, S S, A O, M R S, Selim S, M P B, Gangopadhyay KK, Y A L, T N, D D, S D T, V D, Dutta D, H K, R M, S D, A D, A B, G P, S C, Dhingra A, N P, A AA, M M. Glucodynamics and glucocracy in type 2 diabetes mellitus: clinical evidence and practice-based opinion on modern sulfonylurea use, from an International Expert Group (South Asia, Middle East & Africa) via modified Delphi method. Curr Med Res Opin. 2021 Mar;37(3):403-409. doi: 10.1080/03007995.2020.1864309. Epub 2021 Jan 10.

MeSH Terms

Conditions

Talipes CavusFlatfoot

Interventions

Body HeightWeights and MeasuresBody Mass Index

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)

Body SizeBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Appearance, BodyAnthropometryInvestigative TechniquesPhysiological PhenomenaGrowthGrowth and DevelopmentBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Prof. Dr. Habibe Serap İNAL, Doctor of Physical Therapy

    Istinye University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2025

First Posted

August 13, 2026

Study Start

July 2, 2025

Primary Completion

April 20, 2026

Study Completion

April 29, 2026

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations