Pes PlanusNCT06491212
The Relationship Between Pes Planus, Diaphragm, Postural Control, and Plantar Pressure
A study testing Determination of Foot Deformity Level, Foot Function Index and UFAA-International Physical Activity Questionnaire in people with Pes Planus and Diaphragm Issues, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pes Planus, Diaphragm Issues, Plantar Pressure
- What is being tested?
- Determination of Foot Deformity Level, Foot Function Index and UFAA-International Physical Activity Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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"
Show all 10Show fewer
- 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"
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Alanyaaku
Antalya, Alanya
Ayça ARACI, PhD, +905335461203, ayca.araci@alanya.edu.tr
About this study
Official title: Examination of Diaphragm Function, Postural Control, and Plantar Pressure in Individuals With Pes Planus
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.
Read the detailed description
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.
- Conditions
- Pes Planus, Diaphragm Issues, Plantar Pressure, Postural Control
- Being tested
- Determination of Foot Deformity Level, Foot Function Index, UFAA-International Physical Activity Questionnaire, Diaphragm ultrasound measurements, NeuruCom Balance Master Balnce and Performans Test
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of Foot Deformity LevelDiagnostic test
One of the methods used in our study to determine the presence and degree of pes planus is the navicular drop test.
Foot Function IndexDiagnostic test
Evaluation of Foot Function
UFAA-International Physical Activity QuestionnaireDiagnostic test
To determination of physical activity level.
Diaphragm ultrasound measurementsDiagnostic test
Rehabilitative ultrasound imaging is a method frequently used by physiotherapists to assess muscle function.
NeuruCom Balance Master Balnce and Performans TestDiagnostic test
Balance master will be used for postural stability, static and dynamic balance measurements.
Plantar Pressure AssessmentDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| People with pes planus | Experimental | Individuals with pes planus that we identified according to the inclusion criteria will be evaluated in this group. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: The evaluation will be conducted once and will be completed within 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 May 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Our study was planned to evaluate healthy controls and cases with pes planus.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491212
- Sponsor's protocol ID
- 8880-GOA
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Diaphragm Function, Postural Control, and Plantar Pressure in Individuals With Pes Planus
- ClinicalTrials.gov ID
- NCT06491212
- Acronym / sponsor ID
- 8880-GOA
- Conditions
- Pes Planus, Diaphragm Issues, Plantar Pressure, Postural Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Our study was planned to evaluate healthy controls and cases with pes planus.
| Arm | Type | Receives |
|---|---|---|
| People with pes planus | Experimental | 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 AssessmentIndividuals with pes planus that we identified according to the inclusion criteria will be evaluated in this group. |
| Healthy People | Active comparator | 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 AssessmentVolunteer individuals without pes planus who meet the inclusion criteria will be evaluated for comparison in this group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of Foot Deformity LevelOne of the methods used in our study to determine the presence and degree of pes planus is the navicular drop test. | Diagnostic test | Healthy People, People with pes planus |
| Foot Function IndexEvaluation of Foot Function | Diagnostic test | Healthy People, People with pes planus |
| UFAA-International Physical Activity QuestionnaireTo determination of physical activity level. | Diagnostic test | Healthy People, People with pes planus |
| Diaphragm ultrasound measurementsRehabilitative ultrasound imaging is a method frequently used by physiotherapists to assess muscle function. | Diagnostic test | Healthy People, People with pes planus |
| NeuruCom Balance Master Balnce and Performans TestBalance master will be used for postural stability, static and dynamic balance measurements. | Diagnostic test | Healthy People, People with pes planus |
| Plantar Pressure AssessmentWhen assessing plantar pressure, postural control will be evaluated statically or dynamically, through examination of the behavior of the center of plantar pressure (COP). | Diagnostic test | Healthy People, People with pes planus |
Primary outcome
Navicular Drop Test
Time frame: 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.
Foot Function Index
Time frame: 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
Time frame: 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 of Diaphragmatic Functions
Time frame: 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
Evaluation Balance
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
Related trials for Pes Planus
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determination of Foot Deformity Level, Foot Function Index and UFAA-International Physical Activity Questionnaire in people with Pes Planus and Diaphragm Issues, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navicular Drop Test (time frame: The evaluation will be conducted once and will be completed within 12 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.