NCT07286773

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Dec 2025Oct 2026

First Submitted

Initial submission to the registry

December 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2026

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

December 3, 2025

Last Update Submit

February 4, 2026

Conditions

Keywords

Flexible FlatfootShort Foot ExerciseBiofeedback Training

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    6 Week

Secondary Outcomes (8)

  • Active Range of Motion

    Baseline

  • Active Range of Motion

    6 week

  • FPI-6 (Foot Posture Index-6)

    6 Week

  • Navicular Drop Test

    Baseline

  • Y-Balance Test

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

BF Group

EXPERIMENTAL
Other: Biofeedback assisted exercises

Exerc Group

ACTIVE COMPARATOR
Other: Supervised exercises

Interventions

Biofeedback-assisted short foot exercise group

BF Group

Short foot exercise only group

Exerc Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntary participants aged 18 to 45 years
  • Diagnosis of flexible pes planus
  • No history of surgery, fracture, or psychiatric disorder

You may not qualify if:

  • Diagnosis of rigid pes planus
  • Age younger than 18 years or older than 45 years
  • History of psychiatric disorder or lower extremity trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

İstanbul University-Cerrahpaşa

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

NOT YET RECRUITING

Department of Orthopedics and Traumatology, Istanbul Faculty of Medicine, Istanbul University

Istanbul, Fatih, 34104, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Taner ALPARSLAN, PT, Master's student

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Sezen KARABÖRKLÜ ARGUT, Asst. Prof. Dr.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taner Alparslan, Physiotherapist

CONTACT

Sezen KARABÖRKLÜ ARGUT, Asst. Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physiotherapist

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 16, 2025

Study Start

December 22, 2025

Primary Completion (Estimated)

September 22, 2026

Study Completion (Estimated)

October 22, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations