Evaluation of the Effectiveness of Biofeedback-Assisted Short Foot Exercises in Individuals With Flexible Pes Planus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The Foot and Ankle Ability Measure (FAAM)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participants aged 18 to 45 years
- •Diagnosis of flexible pes planus
- •No history of surgery, fracture, or psychiatric disorder
排除标准
- •Diagnosis of rigid pes planus
- •Age younger than 18 years or older than 45 years
- •History of psychiatric disorder or lower extremity trauma
研究组 & 干预措施
BF Group
干预措施: Biofeedback assisted exercises (Other)
Exerc Group
干预措施: Supervised exercises (Other)
结局指标
主要结局
The Foot and Ankle Ability Measure (FAAM)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Taner Alparslan
Principal Investigator, Physiotherapist
Istanbul University - Cerrahpasa