- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07326020
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- 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
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-
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Ankara, Turkey (Türkiye), 06100
- Hacettepe University
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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
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 |
Intervention / Treatment |
|---|---|
|
No Intervention: control
control group without intervention
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Experimental: joint mobilization group
subtalar and midtarsal joint mobilization in patients with flexible pes planus
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subtalar and midtarsal joint mobilization
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Experimental: myofascial release group
calf and plantar fascia release in patients with flexible pes planus
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calf and plantar fascia release
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What is the study measuring?
Primary Outcome Measures
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
|
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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
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.
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2 months
|
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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.
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2 months
|
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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.
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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.
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2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
December 20, 2025
Primary Completion (Actual)
February 8, 2026
Study Completion (Actual)
February 15, 2026
Study Registration Dates
First Submitted
November 29, 2025
First Submitted That Met QC Criteria
January 3, 2026
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Talipes
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Flatfoot
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Massage
- Myofascial Release Therapy
Other Study ID 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.
Clinical Trials on Pes Planus
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Mustafa Kemal UniversityCompletedFlat Foot [Pes Planus] (Acquired), Unspecified FootTurkey
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Abant Izzet Baysal UniversityCompletedFlat Foot [Pes Planus] (Acquired), Unspecified FootTurkey
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Suleyman Demirel UniversityCompletedFoot Deformities | Hallux Valgus | Pes Planus | Metatarsalgia | Feet Pes Planus (Flatfoot)Turkey
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Riphah International UniversityRecruiting
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Ziauddin UniversityCompleted
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Riphah International UniversityCompleted
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Clinical Trials on joint mobilization
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Riphah International UniversityCompletedLow Back PainPakistan
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Dow University of Health SciencesRecruitingCarpal Tunnel SyndromePakistan
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Foundation University IslamabadRecruiting
-
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National Taiwan University HospitalUnknownMuscle StiffnessTaiwan
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University of AlcalaCompleted
-
NYU Langone HealthCompletedJoint; Derangement, Knee