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OpenTrials
Completed

NCT Number: NCT07326020

Effectiveness of Manuel Therapy Methods in 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Joint Mobilization

Other

subtalar and midtarsal joint mobilization

Myofascial Release

Other

calf and plantar fascia release

Primary outcomes

  1. 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. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hande Guney Deniz

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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