Pes PlanusNCT05836519
Effects of Pes Planus on Quality of Life
An observational study of Pes Planus, run by Saglik Bilimleri Universitesi.
Trial summary
This study will be conducted to investigate the effect of pes planus on physical activity level, exercise capacity and quality of life in young adults. In the study, various evaluations and questionnaires will be applied to the participants by dividing them into two groups by performing the navicular drop test. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scale
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Dec 2023
- 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 30 years
- All sexes
- Adult
Study population: Young adults aged 18-30 years
Who may be able to join
- Being between the ages of 18-30,
- Being able to walk independently (Can use a walking aid)
- Not having a diagnosed psychiatric disorder.
Who cannot join
- Presence of inflammatory, systemic, degenerative and neurological diseases of the foot and ankle,
- Presence of standing equine, hallux valgus and hallux rigidus deformities
- Current history of surgery related to the foot-ankle,
- Existence of cooperation disorders that would prevent participation in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Pes Planus on Physical Activity Level, Exercise Capacity and Quality of Life in Young Adults
This study will be conducted to investigate the effect of pes planus on physical activity level, exercise capacity and quality of life in young adults. In the study, various evaluations and questionnaires will be applied to the participants by dividing them into two groups by performing the navicular drop test. In the study, questionnaires and applications such as Digital dynamometer measurements, Foot Function Index (AFI), International Physical Activity Questionnaire (IPAQ), 6 Minute Walk test, blood pressure, heart rate, saturation measurements, Modified Borg Scale and SF-36 quality of life questionnaire will be used.
Read the detailed description
The aim of this study is to investigate the effect of pes planus on physical activity level, exercise capacity and quality of life in young adults. There are studies examining the effects of pes planus on physical fitness, quality of life, balance and pain levels. However, there are no studies evaluating the effect of pes planus on exercise capacity and physical activity level. It will enable us to have information about its capacity and its effect on quality of life and to obtain workable data. Thanks to these data, the orientation towards treatment options for the negative effects of pes planus will increase. After the approval of the ethics committee, 32 participants who meet the inclusion criteria will be included in the study. The participants will be divided into two groups, 16 with pes planus and 16 without pes planus, by performing the navicular drop test. The foot muscle strength of the participants will be measured with a digital muscle strength device (Lafayette Manual Muscle). The International Physical Activity Questionnaire (IPAQ) will be used for the physical activity level of the participants, the 6-minute walking test for the exercise capacity, the SF-36 quality of life questionnaire for the quality of life, and the Foot Function Index (AFI) for the foot functional status. Heart rate, blood pressure, borg value and oxyhemoglobin value will be measured before and after the 6-minute walking test to be performed on the participants. According to these measurements, the physical activity levels, exercise capacities and quality of life of the participants in both groups will be compared.
- Conditions
- Pes Planus
- Being tested
- Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scale
- Keywords
- Physical Activity, Exercise Capacity, Life Quality
- Medical subject headings
- Flatfoot, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scaleOther
Also called Device Sphygmomanometer, pulseoximeter
Pulse oximetry will be used to measure the oxyhemoglobin value of the participants, and a sphygmomanometer will be used for blood pressure and heart rate measurements.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with a pes planus | Navicular drop test, International Physical Activity Questionnaire (IPAQ), Digital dynamometer measurement, SF-36 quality of life Questionnaire, 6 Minutes Walk test, Foot Function Index, borg value, heart rate, blood pressure, oxyhemoglobin values will be measured for individuals with pes planus. Receives: Other: Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scale | |
| Individuals Without Giving Up Planus | Navicular drop test, International Physical Activity Questionnaire (IPAQ), Digital dynamometer measurement, SF-36 quality of life Questionnaire, 6 Minutes Walk test, Foot Function Index, borg value, heart rate, blood pressure, oxyhemoglobin values will be measured for individuals with pes planus. Receives: Other: Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular Drop Test
It will be used to determine whether participants have pes planus. Participants will undergo a navicular drop test to assess arch height, flexibility, and standing pronation. In the sitting position where the participants do not carry weight with bare feet, while their feet are in contact with the ground, a mark will be placed on the card on the floor at the level of the navicular tubercle.
Then, on the same card, a mark will be made on the same card at the level of the navicular tubercle in the position where they stand up with full weight on the same card. The difference in the distance between the two marked lines will be recorded as the amount of navicular fall in mm. Participants with a diameter of 10 mm or more in the group will be evaluated in the group with pes planus.
Measured: Baseline
Muscle Strength
With the digital muscle strength device, muscle strength assessment will be made on the muscles of the participants who have foot dorsiflexion, plantarflexion, inversion and eversion.
Measured: Baseline
6 minutes walking test
The exercise capacity of the participants will be evaluated with the 6-minute walking test.
Measured: 6 minutes
International Physical Activity Questionnaire-Short form (IPAQ)
The physical activity levels of the participants will be evaluated with the International Physical Activity Questionnaire-Short Form (IPAQ). According to the questions in the questionnaire, metabolic equivalent (MET) scores were determined according to how many days per week, how many hours or minutes per day the activities were performed. According to the survey, it will be determined that as metabolic equivalents increase, physical activity levels are higher, and as they decrease, it will be lower.
Measured: Baseline
Foot Function Index
The foot function status of the participants will be evaluated with the Foot Function Index (AFI). It is a 23-item questionnaire and each item will be given a value between 0-10 according to the visual analog scale and a score will be made between 0-100. The average of all scores will be taken during the calculation. A higher calculated value means more activity limitation, disability, and more pain.
Measured: Baseline
SF-36 quality of life questionnaire
The quality of life of the participants will be evaluated with the Short Form Health Survey (SF-36 Short Form) consisting of 36 questions. This questionnaire evaluates the positive and negative aspects of health status. As a result of the survey, a value between 0-100 will be found. A high score from the scale indicates good quality of life.
Measured: Baseline
Secondary outcomes (1)
Modified Borg Scale
Before and after the 6-minute walk test, the fatigue levels of the participants will be evaluated with the Modified Borg Scale. According to the modified borg scale, participants will score their fatigue with a value between 0 and 10. As the value said by the participants approaches 10, it will be determined that their fatigue levels increase.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (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.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Özdemir, Saglik Bilimleri Universitesi
- Investigators
- Esra Pehlivan, assoc.prof, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836519
- Sponsor's protocol ID
- Effects of Giving Up Planus
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 16 May 2023
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pes Planus on Physical Activity Level, Exercise Capacity and Quality of Life in Young Adults
- ClinicalTrials.gov ID
- NCT05836519
- Acronym / sponsor ID
- Effects of Giving Up Planus
- Conditions
- Pes Planus
- Keywords
- Physical Activity, Exercise Capacity, Life Quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 May 2023 (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.
This study will be conducted to investigate the effect of pes planus on physical activity level, exercise capacity and quality of life in young adults. In the study, various evaluations and questionnaires will be applied to the participants by dividing them into two groups by performing the navicular drop test. In the study, questionnaires and applications such as Digital dynamometer measurements, Foot Function Index (AFI), International Physical Activity Questionnaire (IPAQ), 6 Minute Walk test, blood pressure, heart rate, saturation measurements, Modified Borg Scale and SF-36 quality of life questionnaire will be used.
Detailed description
The aim of this study is to investigate the effect of pes planus on physical activity level, exercise capacity and quality of life in young adults. There are studies examining the effects of pes planus on physical fitness, quality of life, balance and pain levels. However, there are no studies evaluating the effect of pes planus on exercise capacity and physical activity level. It will enable us to have information about its capacity and its effect on quality of life and to obtain workable data. Thanks to these data, the orientation towards treatment options for the negative effects of pes planus will increase. After the approval of the ethics committee, 32 participants who meet the inclusion criteria will be included in the study. The participants will be divided into two groups, 16 with pes planus and 16 without pes planus, by performing the navicular drop test. The foot muscle strength of the participants will be measured with a digital muscle strength device (Lafayette Manual Muscle). The International Physical Activity Questionnaire (IPAQ) will be used for the physical activity level of the participants, the 6-minute walking test for the exercise capacity, the SF-36 quality of life questionnaire for the quality of life, and the Foot Function Index (AFI) for the foot functional status. Heart rate, blood pressure, borg value and oxyhemoglobin value will be measured before and after the 6-minute walking test to be performed on the participants. According to these measurements, the physical activity levels, exercise capacities and quality of life of the participants in both groups will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with a pes planus | – | Other: Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scaleNavicular drop test, International Physical Activity Questionnaire (IPAQ), Digital dynamometer measurement, SF-36 quality of life Questionnaire, 6 Minutes Walk test, Foot Function Index, borg value, heart rate, blood pressure, oxyhemoglobin values will be measured for individuals with pes planus. |
| Individuals Without Giving Up Planus | – | Other: Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scaleNavicular drop test, International Physical Activity Questionnaire (IPAQ), Digital dynamometer measurement, SF-36 quality of life Questionnaire, 6 Minutes Walk test, Foot Function Index, borg value, heart rate, blood pressure, oxyhemoglobin values will be measured for individuals with pes planus. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Young adults aged 18-30 years
Key inclusion criteria (3 listed)
- Being between the ages of 18-30,
- Being able to walk independently (Can use a walking aid)
- Not having a diagnosed psychiatric disorder.
Key exclusion criteria (4 listed)
- Presence of inflammatory, systemic, degenerative and neurological diseases of the foot and ankle,
- Presence of standing equine, hallux valgus and hallux rigidus deformities
- Current history of surgery related to the foot-ankle,
- Existence of cooperation disorders that would prevent participation in 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 |
|---|---|---|
| Survey Navicular Drop test, International Physical Activity Questionnaire (IPAQ) Short Form, 6-minute walk test, Foot Function Index (AFI), SF-36 quality of life questionnaire, Modified borg scaleAlso: Device Sphygmomanometer, pulseoximeterPulse oximetry will be used to measure the oxyhemoglobin value of the participants, and a sphygmomanometer will be used for blood pressure and heart rate measurements. | Other | Individuals Without Giving Up Planus, Individuals with a pes planus |
Primary outcome
Navicular Drop Test
Time frame: Baseline
It will be used to determine whether participants have pes planus. Participants will undergo a navicular drop test to assess arch height, flexibility, and standing pronation. In the sitting position where the participants do not carry weight with bare feet, while their feet are in contact with the ground, a mark will be placed on the card on the floor at the level of the navicular tubercle. Then, on the same card, a mark will be made on the same card at the level of the navicular tubercle in the position where they stand up with full weight on the same card. The difference in the distance between the two marked lines will be recorded as the amount of navicular fall in mm. Participants with a diameter of 10 mm or more in the group will be evaluated in the group with pes planus.
Muscle Strength
Time frame: Baseline
With the digital muscle strength device, muscle strength assessment will be made on the muscles of the participants who have foot dorsiflexion, plantarflexion, inversion and eversion.
6 minutes walking test
Time frame: 6 minutes
The exercise capacity of the participants will be evaluated with the 6-minute walking test.
International Physical Activity Questionnaire-Short form (IPAQ)
Time frame: Baseline
The physical activity levels of the participants will be evaluated with the International Physical Activity Questionnaire-Short Form (IPAQ). According to the questions in the questionnaire, metabolic equivalent (MET) scores were determined according to how many days per week, how many hours or minutes per day the activities were performed. According to the survey, it will be determined that as metabolic equivalents increase, physical activity levels are higher, and as they decrease, it will be lower.
Foot Function Index
Time frame: Baseline
The foot function status of the participants will be evaluated with the Foot Function Index (AFI). It is a 23-item questionnaire and each item will be given a value between 0-10 according to the visual analog scale and a score will be made between 0-100. The average of all scores will be taken during the calculation. A higher calculated value means more activity limitation, disability, and more pain.
SF-36 quality of life questionnaire
Time frame: Baseline
The quality of life of the participants will be evaluated with the Short Form Health Survey (SF-36 Short Form) consisting of 36 questions. This questionnaire evaluates the positive and negative aspects of health status. As a result of the survey, a value between 0-100 will be found. A high score from the scale indicates good quality of life.
1 secondary outcome
Modified Borg Scale
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Esra Pehlivan, assoc.prof study director
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
An observational study of Pes Planus, run by Saglik Bilimleri Universitesi.
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 3 inclusion and 4 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Esra PEHLİVAN, assoc.prof (02163463636, esra.pehlivan@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navicular Drop Test (time frame: Baseline). 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 16 May 2023.