Pes PlanusNCT04179591
Effects of Exercise and Insole on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Pes Planus
A study testing Exercise and Orthesis in people with Pes Planus, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Exercise and Orthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2019to 26 Jul 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- being between 18 and 40 years of age,
- having Navicular drop test greater than 10 mm,
- having Foot posture index-6 greater than or equal to 6,
- having bilateral flexible pes planus.
Who cannot join
- a lack of anatomical integrity of the foot,
- a history of surgery or trauma in the foot region,
- other musculoskeletal or neurological problems which may affect balance and gait performance.
- having received any treatment for lower extremity disorders including pes planus within the last 1 year
- having a body mass index equal to or greater than 30.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University, Institute of Health Sciences
Izmir, 35340
About this study
Official title: Comparison of the Effects of Foot Exercise Program and Arch Support Insoles on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Flexible Pes Planus
The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus.
Read the detailed description
The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus. Forty-two individuals with flexible pes planus will be recruited into the study according to the inclusion criteria. Participants will be randomly divided into three groups: (1) Exercise, (2) Insole, (3) Exercise plus Insole. Exercises will be performed three times per week for six weeks, also custom-made insoles will be worn for six weeks. Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6. Plantar force variables will be recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the 6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds: self-selected slow, normal and fast speeds, (3) Walking just after the heel-rise test for endurance. Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA). The assessments will be made pre/post intervention and at 6-weeks follow-up.
- Conditions
- Pes Planus
- Being tested
- Exercise, Orthesis
- Keywords
- Pes planus, Foot posture, Plantar pressure variables, Balance, Short foot exercises, Tibials posterior strengthening, Intrinsic foot muscles, Custom-made insole, Arch support insole
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Intrinsic foot muscles and tibialis posterior strengthening exercises
OrthesisOther
Customized arch support insoles
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercises will be performed three times per week for six weeks. Receives: Other: Exercise |
| Insole | Experimental | Customized arch support insoles will be worn for six weeks. Receives: Other: Orthesis |
| Exercise plus Insole | Experimental | Exercises will be performed three times per week, and customized arch support will be worn for six weeks. Receives: Other: Exercise; Other: Orthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot posture
Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6.
Measured: Change in foot posture measures from baseline to six weeks and to twelve weeks
Balance
Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).
Measured: Change in balance scores from baseline to six weeks and to twelve weeks
Plantar force variables
Plantar force variables will be recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the 6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds: self-selected slow, normal, and fast speeds, (3) Walking just after the heel-rise test for endurance.
Measured: Change in plantar pressure variables from baseline to six weeks and to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start30 Nov 2019
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Müge KIRMIZI, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179591
- Sponsor's protocol ID
- Müge KIRMIZI
- Status last verified
- Dec 2021
- First submitted
- 24 Nov 2019
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Foot Exercise Program and Arch Support Insoles on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Flexible Pes Planus
- ClinicalTrials.gov ID
- NCT04179591
- Acronym / sponsor ID
- Müge KIRMIZI
- Conditions
- Pes Planus
- Keywords
- Pes planus, Foot posture, Plantar pressure variables, Balance, Short foot exercises, Tibials posterior strengthening, Intrinsic foot muscles, Custom-made insole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 27 Nov 2019 (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.
The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus.
Detailed description
The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus. Forty-two individuals with flexible pes planus will be recruited into the study according to the inclusion criteria. Participants will be randomly divided into three groups: (1) Exercise, (2) Insole, (3) Exercise plus Insole. Exercises will be performed three times per week for six weeks, also custom-made insoles will be worn for six weeks. Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6. Plantar force variables will be recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the 6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds: self-selected slow, normal and fast speeds, (3) Walking just after the heel-rise test for endurance. Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA). The assessments will be made pre/post intervention and at 6-weeks follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseExercises will be performed three times per week for six weeks. |
| Insole | Experimental | Other: OrthesisCustomized arch support insoles will be worn for six weeks. |
| Exercise plus Insole | Experimental | Other: Exercise, Other: OrthesisExercises will be performed three times per week, and customized arch support will be worn for six weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being between 18 and 40 years of age,
- having Navicular drop test greater than 10 mm,
- having Foot posture index-6 greater than or equal to 6,
- having bilateral flexible pes planus.
Key exclusion criteria (5 listed)
- a lack of anatomical integrity of the foot,
- a history of surgery or trauma in the foot region,
- other musculoskeletal or neurological problems which may affect balance and gait performance.
- having received any treatment for lower extremity disorders including pes planus within the last 1 year
- having a body mass index equal to or greater than 30.
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 |
|---|---|---|
| ExerciseIntrinsic foot muscles and tibialis posterior strengthening exercises | Other | Exercise, Exercise plus Insole |
| OrthesisCustomized arch support insoles | Other | Exercise plus Insole, Insole |
Primary outcome
Foot posture
Time frame: Change in foot posture measures from baseline to six weeks and to twelve weeks
Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6.
Balance
Time frame: Change in balance scores from baseline to six weeks and to twelve weeks
Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).
Plantar force variables
Time frame: Change in plantar pressure variables from baseline to six weeks and to twelve weeks
Plantar force variables will be recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the 6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds: self-selected slow, normal, and fast speeds, (3) Walking just after the heel-rise test for endurance.
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 3 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Orthesis in people with Pes Planus, run by Dokuz Eylul 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 4 inclusion and 5 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 3 Jan 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?
Foot posture (time frame: Change in foot posture measures from baseline to six weeks and to twelve weeks). The study lists 3 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 3 Jan 2022.