Effectiveness of Manuel Therapy Methods in Pes Planus

April 1, 2026 updated by: Hande Guney Deniz

Comparison of the Immediate Effects of Different Manual Therapy Methods in Physically Active Individuals With Pes Planus

The aim of this study is to compare the immediate effects of joint-oriented manual therapy and soft tissue-oriented manual therapy on dorsiflexion angle, static and dynamic balance, muscle-tendon mechanical properties, and thermal variables in physically active individuals with flexible pes planus. The research will be conducted between November 2025 and January 2026 at Hacettepe University, Faculty of Physical Therapy and Rehabilitation. Individuals aged 18-35 years with a Tegner Activity Score between 4 and 6 will be included. Participants will be allocated into three groups: soft tissue-oriented manual therapy group, joint-oriented manual therapy group, and control group. Following randomization, the respective intervention will be applied to the intervention groups, while no intervention will be administered to the control group. Assessments will include the dorsiflexion range of motion (weight-bearing lunge test), myotonometric measurements (Myoton-Pro), static balance (Kinvent force platform), dynamic balance (Y-balance test), and thermographic imaging (FLIR E52). The outcomes of this study are expected to contribute to understanding the immediate effectiveness of manual therapy approaches applied in asymptomatic pes planus and to identify the method providing optimal benefit. Furthermore, the differences observed between individuals with pes planus and healthy controls will serve as a guide for clinical assessments of pes planus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for all Groups:

  • Navicular Drop Test ≥ 10 mm
  • Foot Posture Index (FPI) > 6
  • Tegner Activity Scale score between 4 and 6 (inclusive)
  • Age between 18 and 35 years

Exclusion Criteria for All Groups:

  • Diagnosis of posterior tibial tendinopathy by an orthopedic surgeon
  • Presence of plantar fasciitis or moderate/severe hallux valgus
  • History of lower extremity surgery or trauma
  • Presence of neurological, metabolic, or other musculoskeletal disorders that may affect gait or balance performance
  • Receipt of any treatment for pes planus within the past year
  • Body mass index (BMI) greater than 30 kg/m²
  • Regular participation in sports activities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control
control group without intervention
Experimental: joint mobilization group
subtalar and midtarsal joint mobilization in patients with flexible pes planus
Other: joint mobilization
subtalar and midtarsal joint mobilization
Experimental: myofascial release group
calf and plantar fascia release in patients with flexible pes planus
Other: myofascial release
calf and plantar fascia release

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
static balance
Time Frame: 2 months
1 Static Balance Measurement Static balance will be assessed using the Kinvent K-Plates (Kinvent, Montpellier, France), a reliable portable force plate with a 1000 Hz sampling rate. Participants will stand on one leg with hands on hips and the other leg flexed, focusing on a point 5 m away for 10 s. The test will be repeated with eyes closed. Postural oscillations (mm) and center of pressure (COP) (mm) data will be reported instantly via the mobile app. Each condition will be measured three times.
2 months
dynamic balance
Time Frame: 2 months
Dynamic Balance Measurement Dynamic balance will be assessed using the Y-Balance Test platform (Move2Perform, Evansville, USA). Participants will reach in anterior, posteromedial, and posterolateral directions while maintaining single-leg stance, hands on hips. The maximum reach distance(cm) in each direction will be recorded. After practice trials, three valid attempts per direction will be completed. Results will be expressed as normalized composite scores(%) relative to limb length.
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
myotonometric muscle tone
Time Frame: 2 months
Muscle tone (Hz), will be assessed using the Myoton-Pro myotonometer (Myoton SA, Tallinn, Estonia; ICC: 0.76-0.86). Measurements will be taken from the Tibialis Anterior, Medial and Lateral Gastrocnemius, Soleus, Achilles tendon, and Plantar Fascia. The 3 mm probe will be applied perpendicularly to the skin (<3% error). Each site will be tested in standardized positions (supine or prone) and measured three times to obtain mean values for each mechanical property.
2 months
myotonometric muscle stiffness
Time Frame: 2 months
Muscle stiffness (N/m) will be assessed using the Myoton-Pro myotonometer (Myoton SA, Tallinn, Estonia; ICC: 0.76-0.86). Measurements will be taken from the Tibialis Anterior, Medial and Lateral Gastrocnemius, Soleus, Achilles tendon, and Plantar Fascia. The 3 mm probe will be applied perpendicularly to the skin (<3% error). Each site will be tested in standardized positions (supine or prone) and measured three times to obtain mean values for each mechanical property.
2 months
ankle dorsiflexion range of motion
Time Frame: 2 months
Ankle dorsiflexion ROM will be assessed with the Weight-Bearing Lunge Test (WBLT), a reliable method (ICC > 0.90). Participants will lunge toward a wall, keeping the heel in contact with the floor. The maximum distance (cm) from the great toe to the wall at which the knee touches without heel lift will be recorded. At this final position, a digital inclinometer will be placed on the tibia's midline to determine the tibial inclination angle (°). Measurements will be taken on both limbs under identical conditions.
2 months
skin surface thermographic measurement
Time Frame: 2 months
Skin surface temperature (°C) will be assessed using a FLIR E52 thermographic camera (240×180 px infrared resolution, 50 mK sensitivity). Images will be captured in a controlled environment (23 ± 1°C; 40-60% humidity) and analyzed offline with Flir ResearchIR Max 4. Participants will acclimate for 15 min before testing. The emissivity will be set at 0.98, rainbow palette (27-35°C scale) applied, and the camera placed 1 m away, perpendicular to the skin. In the prone position, plantar fascia and sole temperatures will be recorded; in standing, calf and Achilles tendon regions will be imaged, with the highest temperature (°C) documented for each area.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hande Guney Deniz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hande Guney-Deniz, Prof. Dr, Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Departmen of Musculoskeletal Physiotherapy and Rehabilitation, Ankara, Türkiye

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pesplanus2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will be shared with a plausible reason.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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