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临床试验/NCT06491212
NCT06491212招募中不适用

Examination of Diaphragm Function, Postural Control, and Plantar Pressure in Individuals With Pes Planus

Alanya Alaaddin Keykubat University2 个研究点 分布在 2 个国家目标入组 34 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
34
试验地点
2
主要终点
Foot Function Index

研究概览

简要总结

Our primary aim is to compare diaphragm function (resting thickness, activity/resting thickness ratio indicating contractility), postural control, and plantar pressure between individuals with pes planus and healthy controls without pes planus.

详细描述

Pes planus deformity, by causing pronation during standing, affects the biomechanics of the lower extremities. Improper foot positioning can lead to changes in load distribution under the sole, and consequently, abnormal tensions in the soft tissues of the feet can spread to the upper body parts through the myofascial system. In light of all this information, our primary aim is to examine the diaphragm function and thickness in individuals with pes planus deformity and healthy individuals, and to investigate the relationship between diaphragm thickness and balance. Additionally, our secondary aim is to evaluate the relationship between pes planus, diaphragm thickness, and balance.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for individuals with Pes Planus Deformity
  • Willing to participate in the study voluntarily
  • Having a Navicular drop test value of 10mm or above
  • Being between the ages of 18-30
  • Having the physical capacity to perform assessments and tests
  • Having a body mass index of 18-25 kg/m²

排除标准

  • Exclusion criteria for individuals with Pes Planus Deformity:
  • Termination of voluntariness
  • Those with rigid flatfoot, pes cavus, hallux valgus, hallux rigidus, or calcaneal spur deformity
  • Those with chronic systematic and metabolic diseases (e.g., diabetes mellitus, rheumatoid arthritis, etc.) and musculoskeletal problems (e.g., pes planus) that may affect foot functions and gait
  • Those with any surgical history likely to affect balance, lower extremity strength, and postural control
  • Those with any visual/vestibular, musculoskeletal, or neurological problems"
  • Inclusion criteria for healthy participants:
  • Willing to participate in the study voluntarily
  • Being between the ages of 18-30
  • Having the physical capacity to perform assessments and tests
  • Having a body mass index of 18-25 kg/m²
  • Having the ideal height of the medial longitudinal arch of the foot (not having pes planus)
  • Exclusion criteria for healthy participants:
  • Termination of voluntariness
  • Those with chronic systematic and metabolic diseases (e.g., diabetes mellitus, rheumatoid arthritis, etc.) and musculoskeletal problems (e.g., pes planus) that may affect foot functions and gait
  • Those with any surgical history likely to affect balance, lower extremity strength, and postural control
  • Those with any visual/vestibular, musculoskeletal, or neurological problems"

结局指标

主要结局

Foot Function Index

时间窗: The evaluation will be conducted once and will be completed within 12 months.

The Foot Function Index consists of 3 subscales: pain, disability and activity limitation. The pain subscale, consisting of nine items, measures the level of foot pain in various situations, while the disability subscale determines the degree of difficulty in performing various functional activities due to foot problems. The five-item activity limitation subscale assesses limitations in activities due to foot problems. Individuals score all items using the Visual Analog Scale (VAS), taking into account their foot condition one week ago. To calculate subscale and total scores, the score for each item is summed, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability and activity limitation.

UFAA-International Physical Activity Questionnaire

时间窗: TThe evaluation will be conducted once and will be completed within 12 months.

In our study, the self-administered short form of the questionnaire, which includes the "last seven days", will be used to assess physical activity level. Minutes, days and METs (multiples of resting oxygen consumption) are multiplied to obtain a score as "MET-minutes/week". Physical activity levels are classified as physically inactive (\<600 MET-min/week), low physical activity (600 - 3000 MET-min/week) and adequate physical activity (\>3000 MET-min/week). In the calculation of energy expenditure for physical activities, the weekly duration (minutes) of each activity is multiplied by the MET energy values created for the International Physical Activity Questionnaire. Thus, energy expenditures for vigorous, moderate, walking, sitting and total physical activities for each individual are obtained in MET-min/week.

Evaluation Balance

时间窗: The evaluation will be conducted once and will be completed within 12 months.

NeuroCom Balance Master balance and performance test device (NeuroCom System Version 8.1.0, B 100718, 1989- 2004 NeuroCom® International Inc. USA) will be used for the evaluation of balance. Balance master is a valid and reliable test device widely used in postural stability, static and dynamic balance measurements.

Plantar Pressure Assessment

时间窗: The evaluation will be conducted once and will be completed within 12 months.

Tekscan MatScan™ Pressure Mat System (Tekscan Inc. Boston, USA) will be used to evaluate plantar pressure in the study.The assessments will be performed statically and dynamically. COF ellipse area (cm2), COF velocity (cm/s), COF deviation length (cm), anteroposterior deviation COFx (cm), mediolateral deviation COFy (cm) data obtained in the evaluations and weight values for right-left and anteroposterior feet will be recorded.

Navicular Drop Test

时间窗: The evaluation will be conducted once and will be completed within 12 months.

One of the methods used in our study to determine the presence and degree of pes planus is the navicular drop test. If the navicular height difference is between 6-9 mm, it is considered normal MLA, and if it is 10 mm or more, it is considered pes planus.

Evaluation of Diaphragmatic Functions

时间窗: The evaluation will be conducted once and will be completed within 12 months.

The evaluations will be performed with B-mode for bilateral hemidiaphragm in the supine position of the participant. Thickness measurements will be made between hyperechoic peritoneal and pleural borders and recorded in mm (24,25). The thickening fraction (%), which shows the constrictibility of the muscle, in other words, the change in thickness, will be calculated using the formula "(deep inspiration thickness-calm expiration thickness) x 100 / calm expiration thickness

次要结局

未报告次要终点

研究者

发起方
Alanya Alaaddin Keykubat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayça Araci

Assistant professor

Alanya Alaaddin Keykubat University

研究点 (2)

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