ClinicalTrials.gg
Not yet recruitingNCT05836519Updated May 16, 2023

Effects of Pes Planus on Quality of Life

An observational study in Pes Planus, sponsored by Saglik Bilimleri Universitesi. Not yet recruiting. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Saglik Bilimleri Universitesi · Observational

From the registry’s dates

  • Primary completion was expected by May 2023, 3 years 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
18 Years to 30 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pes Planus

Keywords

  • Physical Activity
  • Exercise Capacity
  • Life Quality
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 32 is below the median of 47 across 48 observational studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Young adults aged 18-30 years

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being between the ages of 18-30,
  • Being able to walk independently (Can use a walking aid)
  • Not having a diagnosed psychiatric disorder.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    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

Interventions

  • OtherSurvey 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

    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.

    Also known as: Device Sphygmomanometer, pulseoximeter

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 6 minutes walking test

    The exercise capacity of the participants will be evaluated with the 6-minute walking test.

    Time frame: 6 minutes

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: 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.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05836519
Responsible party
Meryem Özdemir (Phsiotherapy Student, Saglik Bilimleri Universitesi) — Principal investigator
First posted
May 1, 2023
Start date
May 2023 (estimated)
Primary completion
May 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
May 16, 2023

Study contacts

Esra PEHLİVAN, assoc.prof
Contact
esra.pehlivan@sbu.edu.tr
02163463636
Meryem ÖZDEMİR
Contact
ozdemirmeryem248@gmail.com
05435088786
Esra Pehlivan, assoc.prof
study director · Saglik Bilimleri Universitesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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