Evaluation of the Effectiveness of Biofeedback-Assisted Short Foot Exercises in Individuals With Flexible Pes Planus: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istanbul University - Cerrahpasa
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- The Foot and Ankle Ability Measure (FAAM)
Overview
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
Detailed Description
Study Design and Objective
This randomized controlled trial aims to compare the effects of biofeedback-assisted short foot exercises and traditional short foot exercises on plantar pressure distribution, foot posture, balance, and functional ability in individuals with flexible pes planus.
Participants
Voluntary participants aged 10 to 35 years, diagnosed with flexible pes planus, with no history of foot or ankle surgery, fracture, or psychiatric disorder, will be included in the study.
Individuals diagnosed with rigid pes planus, those younger than 10 or older than 35 years, or those with a history of psychiatric illness or lower extremity trauma will be excluded.
Randomization and Groups
Participants will be randomly assigned to two equal groups using a simple randomization method:
Group 1: Short Foot Exercise (SFE) group (without biofeedback)
Group 2: Biofeedback-Assisted Short Foot Exercise (SFE) group
Exercise Intervention
Both groups will participate in a structured 6-week exercise program, performed twice per week, for a total of 12 sessions.
Each session will begin with a 5-minute warm-up period, including:
Towel curl exercises
Resisted ankle movements using a theraband (dorsiflexion, plantar flexion, inversion)
Ball-grasping exercises with the foot
The main intervention, the short foot exercise (SFE), aims to activate the medial longitudinal arch by drawing the first metatarsal head toward the heel without toe flexion. Exercise intensity and body positions will be progressively adjusted throughout the intervention period.
Outcome Measures
Assessments will be conducted before and after the 6-week intervention period using the following outcome measures:
Pedobarographic Analysis: Measurement of plantar pressure distribution (g/cm²) and contact area (cm²) to evaluate plantar load during static stance.
Navicular Drop Test: Measurement of the change in navicular tuberosity height between sitting and standing positions to assess medial longitudinal arch collapse.
Foot Posture Index (FPI-6): Assessment of static foot posture based on six clinical observations, scored from -12 (highly supinated) to +12 (highly pronated).
Y-Balance Test: Evaluation of dynamic balance performance in three directions: anterior, posteromedial, and posterolateral.
Foot and Ankle Ability Measure (FAAM): Self-reported assessment of functional ability using the Activities of Daily Living (ADL) and Sports subscales.
Ankle Range of Motion (ROM): Measurement of ankle dorsiflexion and plantar flexion angles using a goniometer.
Data Analysis
Statistical analyses will be performed using SPSS version 20.0.
Data normality will be assessed using the Shapiro-Wilk test.
Parametric data will be presented as mean ± standard deviation.
Categorical variables will be reported as frequency and percentage.
Between-group comparisons will be conducted using the Independent Samples t-test or the Mann-Whitney U test, depending on data distribution.
Within-group comparisons will be analyzed using the Paired Samples t-test or the Wilcoxon signed-rank test.
Categorical variables will be analyzed using the Pearson chi-square test.
A p-value < 0.05 will be considered statistically significant.
Sample Size Calculation
Sample size and power analysis were performed using the PS-Power and Sample Size program. For the primary outcome measure, the Foot and Ankle Ability Measure (FAAM) score, the minimum clinically important difference (MCID) was set at 8 points, with a standard deviation of 7, based on previously published studies.
Calculations were performed with a 95% confidence level, 80% statistical power, and a significance level of 0.05. The analysis indicated that at least 13 participants per group were required. Considering a potential 20% dropout rate, a total of at least 30 participants (15 per group) will be included in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary participants aged 18 to 45 years
- •Diagnosis of flexible pes planus
- •No history of surgery, fracture, or psychiatric disorder
Exclusion Criteria
- •Diagnosis of rigid pes planus
- •Age younger than 18 years or older than 45 years
- •History of psychiatric disorder or lower extremity trauma
Arms & Interventions
BF Group
Intervention: Biofeedback assisted exercises (Other)
Exerc Group
Intervention: Supervised exercises (Other)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Active Range of Motion(6 week)
- FPI-6 (Foot Posture Index-6)(Baseline)
- Navicular Drop Test(6 week)
- Y-Balance Test(6 Week)
- Active Range of Motion(Baseline)
- FPI-6 (Foot Posture Index-6)(6 Week)
- Navicular Drop Test(Baseline)
- Y-Balance Test(Baseline)
Investigators
Taner Alparslan
Principal Investigator, Physiotherapist
Istanbul University - Cerrahpasa