The Relationship Between Pes Planus, Diaphragm, Postural Control, and Plantar Pressure

NCT06491212 | Recruiting

• 1 other identifier: 8880-GOA
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pes Planus; Diaphragm Issues; Plantar Pressure; Postural Control

Outcome Measures

Primary Outcomes (6)

• Navicular Drop Test

  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.

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

• Foot Function Index

  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.

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

• UFAA-International Physical Activity Questionnaire

  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.

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

• Evaluation of Diaphragmatic Functions

  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

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

• Evaluation Balance

  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.

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

• Plantar Pressure Assessment

  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.

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

Study Arms (2)

People with pes planus

EXPERIMENTAL

Individuals with pes planus that we identified according to the inclusion criteria will be evaluated in this group.

Diagnostic Test: Determination of Foot Deformity Level; Diagnostic Test: Foot Function Index; Diagnostic Test: UFAA-International Physical Activity Questionnaire; Diagnostic Test: Diaphragm ultrasound measurements; Diagnostic Test: NeuruCom Balance Master Balnce and Performans Test; Diagnostic Test: Plantar Pressure Assessment

Healthy People

ACTIVE COMPARATOR

Volunteer individuals without pes planus who meet the inclusion criteria will be evaluated for comparison in this group

Diagnostic Test: Determination of Foot Deformity Level; Diagnostic Test: Foot Function Index; Diagnostic Test: UFAA-International Physical Activity Questionnaire; Diagnostic Test: Diaphragm ultrasound measurements; Diagnostic Test: NeuruCom Balance Master Balnce and Performans Test; Diagnostic Test: Plantar Pressure Assessment

Interventions

Determination of Foot Deformity Level DIAGNOSTIC_TEST

One of the methods used in our study to determine the presence and degree of pes planus is the navicular drop test.

Healthy People; People with pes planus

Foot Function Index DIAGNOSTIC_TEST

Evaluation of Foot Function

Healthy People; People with pes planus

UFAA-International Physical Activity Questionnaire DIAGNOSTIC_TEST

To determination of physical activity level.

Healthy People; People with pes planus

Diaphragm ultrasound measurements DIAGNOSTIC_TEST

Rehabilitative ultrasound imaging is a method frequently used by physiotherapists to assess muscle function.

Healthy People; People with pes planus

NeuruCom Balance Master Balnce and Performans Test DIAGNOSTIC_TEST

Balance master will be used for postural stability, static and dynamic balance measurements.

Healthy People; People with pes planus

Plantar Pressure Assessment DIAGNOSTIC_TEST

When assessing plantar pressure, postural control will be evaluated statically or dynamically, through examination of the behavior of the center of plantar pressure (COP).

Healthy People; People with pes planus

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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"
• 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)
• 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"

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead

Study Sites (1)

Alanyaaku

Antalya, Alanya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Our study was planned to evaluate healthy controls and cases with pes planus.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 9, 2024
• Study Start: May 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 15, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-06

Locations

TU (1)