Pes PlanusNCT07286773
Biofeedback-Assisted Short Foot Exercises in Flexible Flatfoot
A study testing Biofeedback assisted exercises and Supervised exercises in people with Pes Planus, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effects of biofeedback-assisted short foot exercises and traditional short foot exercises in individuals with flexible pes planus. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Biofeedback assisted exercises and Supervised exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 22 Dec 2025to 22 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Voluntary participants aged 18 to 45 years
- Diagnosis of flexible pes planus
- No history of surgery, fracture, or psychiatric disorder
Who cannot join
- Diagnosis of rigid pes planus
- Age younger than 18 years or older than 45 years
- History of psychiatric disorder or lower extremity trauma
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
İstanbul University-Cerrahpaşa
Istanbul, Büyükçekmece, 34500
Taner ALPARSLAN, 00905448022480, babaknavid@ogr.iuc.edu.tr
- Recruiting
Department of Orthopedics and Traumatology, Istanbul Faculty of Medicine, Istanbul University
Istanbul, Fatih, 34104
Mehmet Demirel, Assistant Professor, (0212) 414 20 00, mehmet.demirel@istanbul.edu.tr
About this study
Official title: Evaluation of the Effectiveness of Biofeedback-Assisted Short Foot Exercises in Individuals With Flexible Pes Planus: A Randomized Controlled Trial
The goal of this clinical trial is to compare the effects of biofeedback-assisted short foot exercises and traditional short foot exercises in individuals with flexible pes planus. The study aims to determine whether adding biofeedback to short foot exercises leads to greater improvements in foot biomechanics, balance, and functional ability.
The main questions it aims to answer are:
Read more
Does biofeedback-assisted short foot exercise improve plantar pressure distribution and foot posture more than traditional short foot exercise? Does the use of biofeedback result in greater improvements in balance and functional ability? Researchers will compare a biofeedback-assisted short foot exercise program to a traditional short foot exercise program to evaluate their effects on plantar pressure distribution, foot posture, balance, ankle range of motion, and functional outcomes.
Participants will:
Be randomly assigned to either a traditional short foot exercise group or a biofeedback-assisted short foot exercise group Participate in a supervised exercise program twice per week for 6 weeks Complete pre- and post-intervention assessments, including plantar pressure analysis, balance tests, foot posture evaluation, and self-reported functional questionnaires
- Conditions
- Pes Planus
- Being tested
- Biofeedback assisted exercises, Supervised exercises
- Keywords
- Flexible Flatfoot, Short Foot Exercise, Biofeedback Training
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback assisted exercisesOther
Biofeedback-assisted short foot exercise group
Supervised exercisesOther
Short foot exercise only group
| Study group | Role | What they receive |
|---|---|---|
| BF Group | Experimental | Not described Receives: Other: Biofeedback assisted exercises |
| Exerc Group | Active comparator | Not described Receives: Other: Supervised exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Foot and Ankle Ability Measure (FAAM)
The Foot and Ankle Ability Measure (FAAM) is a validated, self-reported questionnaire designed to assess functional limitations associated with foot and ankle conditions. It consists of two subscales: Activities of Daily Living (ADL) and Sports.
Each item is scored on a 5-point Likert scale, ranging from 0 (unable to perform) to 4 (no difficulty). The total score for each subscale is converted to a percentage, with higher scores indicating better functional ability.
The FAAM has been shown to be reliable, valid, and responsive to clinical change in individuals with musculoskeletal impairments of the foot and ankle.
Measured: Baseline
The Foot and Ankle Ability Measure (FAAM)
The Foot and Ankle Ability Measure (FAAM) is a validated, self-reported questionnaire used to assess functional limitations associated with foot and ankle conditions. It consists of two subscales: Activities of Daily Living (ADL) and Sports.
Each item is scored on a 5-point Likert scale, ranging from 0 (unable to perform) to 4 (no difficulty). Total scores for each subscale are converted to percentage scores, with higher values indicating better functional performance.
The FAAM has demonstrated good reliability, validity, and responsiveness to clinical change in individuals with musculoskeletal impairments of the foot and ankle.
Measured: 6 week
Pedobarographic Analysis
Pedobarographic analysis is an objective method used to assess plantar pressure distribution and contact area during static standing or walking. Measurements are obtained using a computerized pressure platform that records static and dynamic foot loading patterns in real time.
During the assessment, participants stand or walk barefoot on the pedobarographic platform. The system measures the magnitude and distribution of plantar pressures and contact area across different regions of the foot, including the heel, midfoot, and forefoot.
This analysis provides quantitative data on load symmetry, pressure distribution, and medial-lateral balance, which are key indicators of foot biomechanics and medial longitudinal arch function.
Measured: Baseline
Pedobarographic Analys
Pedobarographic analysis is an objective method used to assess plantar pressure distribution and contact area during static standing and walking. Measurements are obtained using a computerized pressure platform that records static and dynamic foot-loading patterns in real time.
During the assessment, participants stand or walk barefoot on the pedobarographic platform. The system measures the magnitude and distribution of plantar pressures and contact area across different regions of the foot, including the heel, midfoot, and forefoot.
This analysis provides quantitative data on load symmetry, pressure concentration, and medial-lateral balance, which are important indicators of foot biomechanics and medial longitudinal arch function.
Measured: 6 Week
Secondary outcomes (8)
Active Range of Motion
Active ankle range of motion, including plantarflexion and dorsiflexion, will be measured according to the guidelines described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
Measured: Baseline
Active Range of Motion
Active ankle range of motion, including plantarflexion and dorsiflexion, will be measured in accordance with the guidelines of the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
Measured: 6 week
FPI-6 (Foot Posture Index-6)
The Foot Posture Index (FPI-6) is a clinical assessment tool used to evaluate static foot posture. It consists of six observational criteria: talar head palpation, curvature above and below the lateral malleolus, calcaneal position in the frontal plane, prominence of the talonavicular joint, height and congruence of the medial longitudinal arch, and forefoot abduction/adduction.
Each item is scored on a 5-point scale ranging from -2 (indicating supination) to +2 (indicating pronation), resulting in a total score ranging from -12 to +12.
Lower scores indicate a more supinated foot posture, whereas higher scores indicate a more pronated foot posture. A score close to zero represents a neutral foot alignment.
Interpretation of Scores
- 12 to -5: Highly supinated
- 4 to -1: Slightly supinated 0 to +5: Neutral
- 6 to +9: Pronated
- 10 to +12: Highly pronated
Measured: 6 Week
Navicular Drop Test
The Navicular Drop Test is a clinical assessment used to evaluate the degree of medial longitudinal arch collapse by measuring the difference between non-weight-bearing and weight-bearing positions of the foot.
During the test, the vertical height of the navicular tuberosity from the floor is measured in both a seated (non-weight-bearing) and a standing (weight-bearing) position using a ruler or digital caliper. The difference between these two measurements, expressed in millimeters (mm), represents the navicular drop value.
A greater navicular drop value indicates increased pronation and lowering of the medial longitudinal arch, whereas smaller values suggest a more neutral or supinated foot posture.
Outcome Metric
Difference in navicular height (mm) between seated and standing positions
Interpretation of Results
< 5 mm: Minimal or no arch drop (supinated tendency)
5-9 mm: Normal range
≥ 10 mm: Excessive pronation / flatfoot tendency
Measured: Baseline
Y-Balance Test
The Y-Balance Test is a dynamic balance assessment tool used to evaluate an individual's ability to maintain postural control while reaching in multiple directions. The participant stands on one leg at the center of a Y-shaped grid and reaches as far as possible with the contralateral leg in three directions: anterior, posteromedial, and posterolateral. The maximum reach distance for each direction is measured in centimeters (cm) and normalized to leg length to reduce inter-individual variability.
The test is performed on both lower extremities, and the mean of three successful trials in each direction is recorded. Greater reach distances indicate better dynamic balance performance, whereas shorter reach distances or asymmetry between limbs may indicate balance deficits.
Outcome Metrics:
Reach distance (cm) in the anterior, posteromedial, and posterolateral directions Composite Y-Balance Score (%) = [(Anterior + Posteromedial + Posterolateral) / (3 × Limb length)] × 100
Measured: Baseline
FPI-6 (Foot Posture Index-6)
The Foot Posture Index (FPI-6) is a clinical assessment tool used to evaluate static foot posture. It consists of six observational criteria: talar head palpation, curvature above and below the lateral malleolus, calcaneal position in the frontal plane, prominence of the talonavicular joint, height and congruence of the medial longitudinal arch, and forefoot abduction/adduction.
Each item is scored on a 5-point scale, ranging from -2 (indicating supination) to +2 (indicating pronation), resulting in a total score ranging from -12 to +12.
Lower scores indicate a more supinated foot posture, whereas higher scores indicate a more pronated foot posture. A score close to zero represents a neutral foot alignment.
Interpretation of Scores
- 12 to -5: Highly supinated
- 4 to -1: Slightly supinated 0 to +5: Neutral
- 6 to +9: Pronated
- 10 to +12: Highly pronated
Measured: Baseline
Y-Balance Test
The Y-Balance Test is a dynamic balance assessment tool used to evaluate an individual's ability to maintain postural control while reaching in multiple directions. The participant stands on one leg at the center of a Y-shaped grid and reaches as far as possible with the contralateral leg in three directions: anterior, posteromedial, and posterolateral. The maximum reach distance for each direction is measured in centimeters (cm) and normalized to leg length to reduce inter-individual variability.
The test is performed on both lower extremities, and the mean of three successful trials in each direction is recorded. Greater reach distances indicate better dynamic balance performance, whereas shorter reach distances or asymmetry between limbs may indicate balance deficits.
Outcome Metrics
Reach distance (cm) in the anterior, posteromedial, and posterolateral directions Composite Y-Balance Score (%) = [(Anterior + Posteromedial + Posterolateral) / (3 × Limb length)] × 100
Measured: 6 Week
Navicular Drop Test
The Navicular Drop Test is a clinical measurement used to assess the degree of medial longitudinal arch collapse by comparing the foot in non-weight-bearing and weight-bearing positions.
During the test, the vertical height of the navicular tuberosity from the floor is measured in both a seated (non-weight-bearing) and a standing (weight-bearing) position using a ruler or digital caliper. The difference between these two measurements, expressed in millimeters (mm), represents the navicular drop value.
A greater navicular drop value indicates increased pronation and lowering of the medial longitudinal arch, whereas smaller values suggest a more neutral or supinated foot posture.
Outcome Metric
Difference in navicular height (mm) between seated and standing positions
Interpretation of Results
< 5 mm: Minimal or no arch drop (supinated tendency)
5-9 mm: Normal range
≥ 10 mm: Excessive pronation / flatfoot tendency
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start22 Dec 2025
- Primary completion22 Sep 2026 (estimated)
- Study completion22 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Alparslan, Istanbul University - Cerrahpasa
- Investigators
- Taner ALPARSLAN, PT, Master's student, Principal investigator, Istanbul University - CerrahpasaSezen KARABÖRKLÜ ARGUT, Asst. Prof. Dr., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286773
- Sponsor's protocol ID
- 0a747ZHs - 2025/689
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Biofeedback-Assisted Short Foot Exercises in Individuals With Flexible Pes Planus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07286773
- Acronym / sponsor ID
- 0a747ZHs - 2025/689
- Conditions
- Pes Planus
- Keywords
- Flexible Flatfoot, Short Foot Exercise, Biofeedback Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 22 Sep 2026 (estimated)
- Study completion
- 22 Oct 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effects of biofeedback-assisted short foot exercises and traditional short foot exercises in individuals with flexible pes planus. The study aims to determine whether adding biofeedback to short foot exercises leads to greater improvements in foot biomechanics, balance, and functional ability.
The main questions it aims to answer are:
Does biofeedback-assisted short foot exercise improve plantar pressure distribution and foot posture more than traditional short foot exercise? Does the use of biofeedback result in greater improvements in balance and functional ability? Researchers will compare a biofeedback-assisted short foot exercise program to a traditional short foot exercise program to evaluate their effects on plantar pressure distribution, foot posture, balance, ankle range of motion, and functional outcomes.
Participants will:
Be randomly assigned to either a traditional short foot exercise group or a biofeedback-assisted short foot exercise group Participate in a supervised exercise program twice per week for 6 weeks Complete pre- and post-intervention assessments, including plantar pressure analysis, balance tests, foot posture evaluation, and self-reported functional questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| BF Group | Experimental | Other: Biofeedback assisted exercises |
| Exerc Group | Active comparator | Other: Supervised exercises |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Voluntary participants aged 18 to 45 years
- Diagnosis of flexible pes planus
- No history of surgery, fracture, or psychiatric disorder
Key exclusion criteria (3 listed)
- Diagnosis of rigid pes planus
- Age younger than 18 years or older than 45 years
- History of psychiatric disorder or lower extremity trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback assisted exercisesBiofeedback-assisted short foot exercise group | Other | BF Group |
| Supervised exercisesShort foot exercise only group | Other | Exerc Group |
Primary outcome
The Foot and Ankle Ability Measure (FAAM)
Time frame: Baseline
The Foot and Ankle Ability Measure (FAAM) is a validated, self-reported questionnaire designed to assess functional limitations associated with foot and ankle conditions. It consists of two subscales: Activities of Daily Living (ADL) and Sports. Each item is scored on a 5-point Likert scale, ranging from 0 (unable to perform) to 4 (no difficulty). The total score for each subscale is converted to a percentage, with higher scores indicating better functional ability. The FAAM has been shown to be reliable, valid, and responsive to clinical change in individuals with musculoskeletal impairments of the foot and ankle.
The Foot and Ankle Ability Measure (FAAM)
Time frame: 6 week
The Foot and Ankle Ability Measure (FAAM) is a validated, self-reported questionnaire used to assess functional limitations associated with foot and ankle conditions. It consists of two subscales: Activities of Daily Living (ADL) and Sports. Each item is scored on a 5-point Likert scale, ranging from 0 (unable to perform) to 4 (no difficulty). Total scores for each subscale are converted to percentage scores, with higher values indicating better functional performance. The FAAM has demonstrated good reliability, validity, and responsiveness to clinical change in individuals with musculoskeletal impairments of the foot and ankle.
Pedobarographic Analysis
Time frame: Baseline
Pedobarographic analysis is an objective method used to assess plantar pressure distribution and contact area during static standing or walking. Measurements are obtained using a computerized pressure platform that records static and dynamic foot loading patterns in real time. During the assessment, participants stand or walk barefoot on the pedobarographic platform. The system measures the magnitude and distribution of plantar pressures and contact area across different regions of the foot, including the heel, midfoot, and forefoot. This analysis provides quantitative data on load symmetry, pressure distribution, and medial-lateral balance, which are key indicators of foot biomechanics and medial longitudinal arch function.
Pedobarographic Analys
Time frame: 6 Week
Pedobarographic analysis is an objective method used to assess plantar pressure distribution and contact area during static standing and walking. Measurements are obtained using a computerized pressure platform that records static and dynamic foot-loading patterns in real time. During the assessment, participants stand or walk barefoot on the pedobarographic platform. The system measures the magnitude and distribution of plantar pressures and contact area across different regions of the foot, including the heel, midfoot, and forefoot. This analysis provides quantitative data on load symmetry, pressure concentration, and medial-lateral balance, which are important indicators of foot biomechanics and medial longitudinal arch function.
8 secondary outcomes
Active Range of Motion
Time frame: Baseline
Active Range of Motion
Time frame: 6 week
FPI-6 (Foot Posture Index-6)
Time frame: 6 Week
Navicular Drop Test
Time frame: Baseline
Y-Balance Test
Time frame: Baseline
FPI-6 (Foot Posture Index-6)
Time frame: Baseline
Y-Balance Test
Time frame: 6 Week
Navicular Drop Test
Time frame: 6 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taner ALPARSLAN, PT, Master's student principal investigator
Istanbul University - Cerrahpasa
Sezen KARABÖRKLÜ ARGUT, Asst. Prof. Dr. principal investigator
Istanbul University - Cerrahpasa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback assisted exercises and Supervised exercises in people with Pes Planus, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taner Alparslan, Physiotherapist (00902128663700, babaknavid@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Foot and Ankle Ability Measure (FAAM) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.