An interventional study of Determination of Foot Deformity Level and Foot Function Index in Pes Planus, Diaphragm Issues and Plantar Pressure, sponsored by Alanya Alaaddin Keykubat University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Alanya Alaaddin Keykubat University · Not applicable, Interventional, and Diagnostic
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.
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.
173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.
This study's planned enrollment of 34 is below the median of 40 across 122 interventional studies indexed under Flatfoot.
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Inclusion Criteria:
Inclusion criteria for individuals with Pes Planus Deformity
Exclusion Criteria:
Inclusion criteria for healthy participants:
Exclusion criteria for healthy participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
One of the methods used in our study to determine the presence and degree of pes planus is the navicular drop test.
Evaluation of Foot Function
To determination of physical activity level.
Rehabilitative ultrasound imaging is a method frequently used by physiotherapists to assess muscle function.
Balance master will be used for postural stability, static and dynamic balance measurements.
When assessing plantar pressure, postural control will be evaluated statically or dynamically, through examination of the behavior of the center of plantar pressure (COP).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: The evaluation will be conducted once and will be completed within 12 months.
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Alanya Alaaddin Keykubat University