Pes PlanusNCT05420272
Comparison of Lower Extremity Biomechanics,Core Endurance, and Performance in Pes Planus : A Controlled Study
An observational study of Pes Planus, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Pes planus is a deformity called "flatfoot" and is defined as the valgus of the hindfoot while loading the foot, the disappearance of the medial longitudinal arch in the midfoot, and the supination of the forefoot relative to the hindfoot. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pes Planus
- What is being tested?
- Trunk performance and endurance lower extremity biomechanic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2022to 20 Sep 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Pes planus
Who may be able to join
- Being 18-35 years
- Being a volunteer to participate in the study.
Who cannot join
- Individuals who have had any previous surgery related to the lower extremities, who have any orthopedic, neurological, and systemic problems that may affect the lower extremity and balance, and those with congenital shortness of the lower extremities and visual impairment will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trunk Endurance and Performance in Pes Planus
Pes planus is a deformity called "flatfoot" and is defined as the valgus of the hindfoot while loading the foot, the disappearance of the medial longitudinal arch in the midfoot, and the supination of the forefoot relative to the hindfoot. The aim of this study is to compare the subtalar angle, q angle, trunk muscle endurance, and performance of individuals with pes planus and healthy controls. Volunteer students between the ages of 18-35 will be included among the students studying at the Health Sciences University Gülhane Faculty of Physiotherapy and Rehabilitation. The feet of individuals who want to be included in the study will be examined by the researchers with the navicular drop test and the presence of pes planus will be determined according to this test. Subtalar Angle to determine the degree of rotation (Varus/Valgus) in the hindfoot, Q Angle for knee biomechanics, Navicular Drop Test to determine flat feet, Mcgill trunk Flexion, Extension, and Lateral Bridge Test to evaluate trunk endurance, Xbox to evaluate lower and upper extremity performance 360Kinect™ game console will be used. In this study, statistical analyzes will be made with SPSS 21 package program (IBM Corp., Armonk, NY, USA). Wilcoxon test or Mann Whitney U will be used after determining the conformity to the normal distribution in the comparison of the values before and after the exercises, individuals with and without flat feet. Results will be evaluated at the significance level of p<0.05. Cohen's d values will be calculated to determine the study effect size.
Read the detailed description
The navicular drop test is a test used to measure the amount of pronation in the foot, which is obtained by subtracting the navicular height measured while standing with weight on the foot, from the navicular height measured in the sitting position without placing weight on the foot. While individuals are sitting on a chair with bare feet, the navicular tubercle will be marked on both feet and marked at the level of the navicular tubercle on a card on the floor. Then, the individual will be asked to stand up, and the navicular tubercle level will be marked again on the same card while giving full weight to the foot. The expression in millimeters of the distance between both lines will be recorded as the amount of navicular drop. The amount of navicular drop between 6 and 9 millimeters will be considered as normal MLA, and if it is 10 millimeters or more, it will be considered as pes planus. This test will be done for both the right foot and the left foot To measure the subtalar angle, the participants will be asked to lie face down with their feet hanging out of the bed. The subtalar neutral position (without the foot in pronation or supination) will be determined, and the calcaneal midline and the distal 1/3 tibial longitudinal midline will be marked with a line. The pivot point of the goniometer will be placed on the midline of the Achilles tendon and one arm will reference the distal 1/3 tibial longitudinal midline while one arm will refer to the calcaneal line and the deviation angle will be recorded. The deviation angle in the valgus direction will be given a negative (-) value, and the deviation angle in the varus direction will be given a positive (+) value. This measurement will be made for both the right foot and the left foot The Q angle is the angle between the line extending from the anterior superior iliac spine to the middle of the patella and the line drawn from the middle of the patella to the tibial tubercle. Measurements will be made by means of a goniometer. Its normal value is 8-14° (average 10°) in men and 11-20° (mean 15°) in women. Right Q angle and left Q angle will be measured with the patient in the supine position and without contracting the quadriceps Mcgill trunk flexion test is a test used to evaluate the endurance of trunk flexor muscles, McGill trunk extension test trunk extensor muscles, McGill lateral bridge test is a test used to evaluate the endurance of core muscles that provide lateral stability. In the Mcgill trunk flexion test, participants will be asked to cross their hands on their chest and will be positioned on the floor with their trunks flexed at 60° and their knees flexed at 90°. Sixty degrees of body flexion will be provided by a stretcher with an adjustable head. It will be ensured that there is no support behind the person during the test. In the Mcgill trunk extension test, the participants will be positioned in the prone position with their spina iliaca anterior superior to the side of the bed. Participants will be asked to extend their upper body straight forward from the edge of the table and will be fixed above their knees with the help of a belt. Before the test starts, the upper extremity will be supported with the help of a stool placed on the floor to prevent fatigue. When ready for the test, the participant will be asked to raise their hands on the stool and cross them in front of their torso and stand parallel to the ground. In the Mcgill lateral bridge test, the participants will lie on their dominant side, place their foot on the other foot, cross their non-dominant arm over their chest and place them on the dominant shoulder, and the dominant forearm shoulder straps. The participant will be asked to stand on the elbow. As soon as the participant is ready, he will be asked to stand on his forearm with his body on a single line, and the stopwatch will be started, which will raise his hips. The person will be asked to maintain the positions for as long as possible. Before the tests, individuals will be shown how to do the tests and they will be given a trial for a few seconds. The stopwatch will be started and the test will be started, in case of any deterioration in its position, the stopwatch will be stopped and the test will be terminated. The elapsed time will be recorded in seconds. Mcgill trunk flexion-extension and lateral bridge tests were previously performed in healthy individuals and their validity and reliability were found to be high. (McGill trunk flexion intra-class correlation coefficient (ICC) = 0.97, McGill trunk extension intra-class correlation coefficient (ICC) = 0.97, McGill lateral bridge intra-class correlation coefficient (ICC) = 0.99) (37.38.39).
Xbox 360Kinect™ game console was used for upper and lower extremity performance evaluation. Xbox Kinect; There is an infrared Kinect camera sensor that can detect user movements without the need for a special controller, the movements of the user in the virtual reality environment can be monitored in real-time on the screen. Before starting the play therapy, the patients were informed about the games by the physiotherapist and they were shown how to play the games. 100 m running game in Kinect Sport for 100 m running performance, single-leg jump game in Kinect Sport for single-leg jump performance, discus throw game for upper extremity performance. will be determined and the scores of the participants will be recorded. Kinect is a valid and reliable method for evaluating upper and lower extremity function In this study, statistical analyzes will be made with SPSS 21 package program (IBM Corp., Armonk, NY, USA). Wilcoxon test or Mann Whitney U will be used after determining the conformity to the normal distribution in the comparison of the values before and after the exercises, individuals with and without flat feet. Results will be evaluated at the significance level of p<0.05. Cohen's d values will be calculated to determine the study effect size.
- Conditions
- Pes Planus
- Being tested
- Trunk performance and endurance lower extremity biomechanic
- Keywords
- pes planus, trunk, subtalar angle, endurance, kinect
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk performance and endurance lower extremity biomechanicBehavioural
Also called asymtopamtic healthy control Trunk performance and endurance lower extremity biomechanic
Trunk performance and endurance lower extremity biomechanic
| Study group | Role | What they receive |
|---|---|---|
| Pes planus | Evaluation group- Trunk performance and endurance lower extremity biomechanics Receives: Behavioral: Trunk performance and endurance lower extremity biomechanic | |
| Control group healthy | Trunk performance and endurance lower extremity biomechanics Receives: Behavioral: Trunk performance and endurance lower extremity biomechanic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Trunk endurance in pes planus and controls
Trunk endurance
Measured: 10 minute
Secondary outcomes (2)
Comparison of Subtalar Angle, q angle
subtalar angle , q angle
Measured: 10 minute
comparison of trunk performance
kinect performance test
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start5 May 2022
- Primary completion10 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Tezel Yıldırım Şahan, Hacettepe University
- Investigators
- Tezel Y Şahan, pHD, Study chair, University of Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420272
- Sponsor's protocol ID
- 2022-170
- Status last verified
- Nov 2022
- First submitted
- 13 Jun 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The authors can want from the corresponding author from journals system.
Publications
Gün, K., M. SaridoĞan, and Ö. Uysal, Pes Planus Tanısında Ayak İzi ve Radyografik Ölçüm Yöntemlerinin Korelasyonu. Turkish Journal of Physical Medicine & Rehabilitation/Turkiye Fiziksel Tip ve Rehabilitasyon Dergisi, 2012. 58(4).
Milenković, S., et al., Incidence of flat foot in high school students. Facta universitatis-series: Physical Education and Sport, 2011. 9(3): p. 275-281.
Aenumulapalli A, Kulkarni MM, Gandotra AR. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J Clin Diagn Res. 2017 Jun;11(6):AC17-AC20. doi: 10.7860/JCDR/2017/26566.10059. Epub 2017 Jun 1.
PubMed 28764143Shih YF, Chen CY, Chen WY, Lin HC. Lower extremity kinematics in children with and without flexible flatfoot: a comparative study. BMC Musculoskelet Disord. 2012 Mar 2;13:31. doi: 10.1186/1471-2474-13-31.
PubMed 22381254
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk Endurance and Performance in Pes Planus
- ClinicalTrials.gov ID
- NCT05420272
- Acronym / sponsor ID
- 2022-170
- Conditions
- Pes Planus
- Keywords
- pes planus, trunk, subtalar angle, endurance, kinect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 5 May 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 15 Jun 2022 (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.
Pes planus is a deformity called "flatfoot" and is defined as the valgus of the hindfoot while loading the foot, the disappearance of the medial longitudinal arch in the midfoot, and the supination of the forefoot relative to the hindfoot. The aim of this study is to compare the subtalar angle, q angle, trunk muscle endurance, and performance of individuals with pes planus and healthy controls. Volunteer students between the ages of 18-35 will be included among the students studying at the Health Sciences University Gülhane Faculty of Physiotherapy and Rehabilitation. The feet of individuals who want to be included in the study will be examined by the researchers with the navicular drop test and the presence of pes planus will be determined according to this test. Subtalar Angle to determine the degree of rotation (Varus/Valgus) in the hindfoot, Q Angle for knee biomechanics, Navicular Drop Test to determine flat feet, Mcgill trunk Flexion, Extension, and Lateral Bridge Test to evaluate trunk endurance, Xbox to evaluate lower and upper extremity performance 360Kinect™ game console will be used. In this study, statistical analyzes will be made with SPSS 21 package program (IBM Corp., Armonk, NY, USA). Wilcoxon test or Mann Whitney U will be used after determining the conformity to the normal distribution in the comparison of the values before and after the exercises, individuals with and without flat feet. Results will be evaluated at the significance level of p<0.05. Cohen's d values will be calculated to determine the study effect size.
Detailed description
The navicular drop test is a test used to measure the amount of pronation in the foot, which is obtained by subtracting the navicular height measured while standing with weight on the foot, from the navicular height measured in the sitting position without placing weight on the foot. While individuals are sitting on a chair with bare feet, the navicular tubercle will be marked on both feet and marked at the level of the navicular tubercle on a card on the floor. Then, the individual will be asked to stand up, and the navicular tubercle level will be marked again on the same card while giving full weight to the foot. The expression in millimeters of the distance between both lines will be recorded as the amount of navicular drop. The amount of navicular drop between 6 and 9 millimeters will be considered as normal MLA, and if it is 10 millimeters or more, it will be considered as pes planus. This test will be done for both the right foot and the left foot To measure the subtalar angle, the participants will be asked to lie face down with their feet hanging out of the bed. The subtalar neutral position (without the foot in pronation or supination) will be determined, and the calcaneal midline and the distal 1/3 tibial longitudinal midline will be marked with a line. The pivot point of the goniometer will be placed on the midline of the Achilles tendon and one arm will reference the distal 1/3 tibial longitudinal midline while one arm will refer to the calcaneal line and the deviation angle will be recorded. The deviation angle in the valgus direction will be given a negative (-) value, and the deviation angle in the varus direction will be given a positive (+) value. This measurement will be made for both the right foot and the left foot The Q angle is the angle between the line extending from the anterior superior iliac spine to the middle of the patella and the line drawn from the middle of the patella to the tibial tubercle. Measurements will be made by means of a goniometer. Its normal value is 8-14° (average 10°) in men and 11-20° (mean 15°) in women. Right Q angle and left Q angle will be measured with the patient in the supine position and without contracting the quadriceps Mcgill trunk flexion test is a test used to evaluate the endurance of trunk flexor muscles, McGill trunk extension test trunk extensor muscles, McGill lateral bridge test is a test used to evaluate the endurance of core muscles that provide lateral stability. In the Mcgill trunk flexion test, participants will be asked to cross their hands on their chest and will be positioned on the floor with their trunks flexed at 60° and their knees flexed at 90°. Sixty degrees of body flexion will be provided by a stretcher with an adjustable head. It will be ensured that there is no support behind the person during the test. In the Mcgill trunk extension test, the participants will be positioned in the prone position with their spina iliaca anterior superior to the side of the bed. Participants will be asked to extend their upper body straight forward from the edge of the table and will be fixed above their knees with the help of a belt. Before the test starts, the upper extremity will be supported with the help of a stool placed on the floor to prevent fatigue. When ready for the test, the participant will be asked to raise their hands on the stool and cross them in front of their torso and stand parallel to the ground. In the Mcgill lateral bridge test, the participants will lie on their dominant side, place their foot on the other foot, cross their non-dominant arm over their chest and place them on the dominant shoulder, and the dominant forearm shoulder straps. The participant will be asked to stand on the elbow. As soon as the participant is ready, he will be asked to stand on his forearm with his body on a single line, and the stopwatch will be started, which will raise his hips. The person will be asked to maintain the positions for as long as possible. Before the tests, individuals will be shown how to do the tests and they will be given a trial for a few seconds. The stopwatch will be started and the test will be started, in case of any deterioration in its position, the stopwatch will be stopped and the test will be terminated. The elapsed time will be recorded in seconds. Mcgill trunk flexion-extension and lateral bridge tests were previously performed in healthy individuals and their validity and reliability were found to be high. (McGill trunk flexion intra-class correlation coefficient (ICC) = 0.97, McGill trunk extension intra-class correlation coefficient (ICC) = 0.97, McGill lateral bridge intra-class correlation coefficient (ICC) = 0.99) (37.38.39).
Xbox 360Kinect™ game console was used for upper and lower extremity performance evaluation. Xbox Kinect; There is an infrared Kinect camera sensor that can detect user movements without the need for a special controller, the movements of the user in the virtual reality environment can be monitored in real-time on the screen. Before starting the play therapy, the patients were informed about the games by the physiotherapist and they were shown how to play the games. 100 m running game in Kinect Sport for 100 m running performance, single-leg jump game in Kinect Sport for single-leg jump performance, discus throw game for upper extremity performance. will be determined and the scores of the participants will be recorded. Kinect is a valid and reliable method for evaluating upper and lower extremity function In this study, statistical analyzes will be made with SPSS 21 package program (IBM Corp., Armonk, NY, USA). Wilcoxon test or Mann Whitney U will be used after determining the conformity to the normal distribution in the comparison of the values before and after the exercises, individuals with and without flat feet. Results will be evaluated at the significance level of p<0.05. Cohen's d values will be calculated to determine the study effect size.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pes planus | – | Behavioral: Trunk performance and endurance lower extremity biomechanicEvaluation group- Trunk performance and endurance lower extremity biomechanics |
| Control group healthy | – | Behavioral: Trunk performance and endurance lower extremity biomechanicTrunk performance and endurance lower extremity biomechanics |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pes planus
Key inclusion criteria (2 listed)
- Being 18-35 years
- Being a volunteer to participate in the study.
Key exclusion criteria (1 listed)
- Individuals who have had any previous surgery related to the lower extremities, who have any orthopedic, neurological, and systemic problems that may affect the lower extremity and balance, and those with congenital shortness of the lower extremities and visual impairment will be excluded from the study.
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 |
|---|---|---|
| Trunk performance and endurance lower extremity biomechanicAlso: asymtopamtic healthy control Trunk performance and endurance lower extremity biomechanicTrunk performance and endurance lower extremity biomechanic | Behavioural | Control group healthy, Pes planus |
Primary outcome
Comparison of Trunk endurance in pes planus and controls
Time frame: 10 minute
Trunk endurance
2 secondary outcomes
Comparison of Subtalar Angle, q angle
Time frame: 10 minute
comparison of trunk performance
Time frame: 10 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- BackgroundGün, K., M. SaridoĞan, and Ö. Uysal, Pes Planus Tanısında Ayak İzi ve Radyografik Ölçüm Yöntemlerinin Korelasyonu. Turkish Journal of Physical Medicine & Rehabilitation/Turkiye Fiziksel Tip ve Rehabilitasyon Dergisi, 2012. 58(4).
- BackgroundMilenković, S., et al., Incidence of flat foot in high school students. Facta universitatis-series: Physical Education and Sport, 2011. 9(3): p. 275-281.
- Background: PubMed 28764143Aenumulapalli A, Kulkarni MM, Gandotra AR. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J Clin Diagn Res. 2017 Jun;11(6):AC17-AC20. doi: 10.7860/JCDR/2017/26566.10059. Epub 2017 Jun 1.
- Background: PubMed 22381254Shih YF, Chen CY, Chen WY, Lin HC. Lower extremity kinematics in children with and without flexible flatfoot: a comparative study. BMC Musculoskelet Disord. 2012 Mar 2;13:31. doi: 10.1186/1471-2474-13-31.
- Individual participant dataSharing planned: Undecided. The authors can want from the corresponding author from journals system.
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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.
Tezel Y Şahan, pHD study chair
University of Health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pes Planus, run by Hacettepe 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Trunk endurance in pes planus and controls (time frame: 10 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420272, which also lists 4 linked publications.
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 29 Nov 2022.