Pes PlanusNCT07895602
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
A study testing Custom 3D Printed Insoles and Short Foot Exercises in people with Pes Planus, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The primary purpose of this study is to evaluate the effects of combining custom 3D-printed medial arch-supported insoles with short foot exercises on foot posture, balance, and gait parameters in individuals with pes planus (flat feet). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Custom 3D Printed Insoles and Short Foot Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2026to 26 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 35 years.
- Presence of pes planus, defined as a Navicular Drop test value > 10 mm and a Foot Posture Index-6 (FPI-6) score between +6 and +12.
- Willingness to volunteer for the study and provide written informed consent.
Who cannot join
- Presence of rigid pes planus.
- Hallux valgus.
- Hallux rigidus.
- Calcaneal spur (heel spur).
- History of any neurological, cardiovascular, or systemic diseases.
- History of any orthopedic disease affecting the lower extremities.
- History of lower extremity surgery.
- Body Mass Index (BMI) ≥ 30 kg/m².
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kutahya Health Science University
Kütahya
Emrah Afsar, Phd, 5062527008, emrah.afsar@ksbu.edu.tr
Emrah Afsar, Phd
About this study
Official title: The Effect of Custom 3D Printed Insoles and Short Foot Exercises on Foot Posture, Balance, and Gait Parameters in Individuals With Pes Planus
The primary purpose of this study is to evaluate the effects of combining custom 3D-printed medial arch-supported insoles with short foot exercises on foot posture, balance, and gait parameters in individuals with pes planus (flat feet). Furthermore, the study will investigate the impact of this combined intervention on secondary outcomes, including pain levels, health-related quality of life, and functional exercise capacity measured by the 6-Minute Walk Test.
Read the detailed description
Participants will be recruited through personal networks and social media platforms using a snowball sampling method. Potential candidates will be screened for pes planus in accordance with established literature protocols, utilizing the Foot Posture Index-6 (FPI-6) and the Navicular Drop Test.
Eligible individuals who meet the criteria for pes planus will undergo 3D foot scanning. Based on the obtained data, customized medial arch-supported insoles will be manufactured using 3D printing technology. Participants will be instructed to use these custom insoles in their daily lives for a total of 8 weeks. Concurrently, they will be assigned a daily short foot exercise (intrinsic muscle training) program. Each exercise repetition will involve a 5-second hold, and the entire protocol will be maintained for 8 weeks.
All clinical, functional, and biomechanical evaluations-including foot posture, dynamic balance, comprehensive gait and plantar pressure analysis (via the Zebris system), pain intensity, quality of life, and functional walking capacity-will be conducted at two time points: at baseline and at the end of the 8-week intervention period.
For statistical analysis, depending on the normality of data distribution, either a paired t-test or a Wilcoxon signed-rank test will be used to evaluate within-group changes between baseline and week 8. To determine the magnitude of the intervention effect, Cohen's d effect sizes for dependent measures will be calculated and reported alongside 95% confidence intervals.
- Conditions
- Pes Planus
- Being tested
- Custom 3D Printed Insoles and Short Foot Exercises
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom 3D Printed Insoles and Short Foot ExercisesOther
The intervention consists of a combined biomechanical and active rehabilitation approach for individuals with pes planus:
- Custom 3D Printed Insoles: The participants' feet will be 3D scanned, and custom insoles will be manufactured using 3D printing technology. Participants will be recommended to use these personalized insoles during their daily activities for a total of 8 weeks.
- Short Foot Exercises (SFE): Participants will perform a short foot exercise (foot core / intrinsic muscle) program aimed at increasing intrinsic foot muscle activation. The exercise protocol will be performed daily for 8 weeks, with each repetition held for five seconds.
| Study group | Role | What they receive |
|---|---|---|
| Insole and Exercise Group | Experimental | All participants in this group will receive custom 3D printed insoles and perform a short foot exercise program. Receives: Other: Custom 3D Printed Insoles and Short Foot Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Posture Index-6 (FPI-6)
Assesses foot posture across 6 criteria. Total scores range from -12 (highly supinated) to +12 (highly pronated).
Measured: Baseline and 8 Weeks
Navicular Drop Test (NDT)
Assesses medial longitudinal arch height difference (in mm) between seated (non-weight bearing) and standing (weight bearing) positions. Higher values indicate increased pronation.
Measured: Baseline and 8 Weeks
Modified Star Excursion Balance Test (MSEBT)
Evaluates dynamic balance by measuring the maximum reach distance (in cm) in three directions: anterior, posteromedial, and posterolateral.
Measured: Baseline and 8 Weeks
Spatiotemporal Gait and Plantar Pressure Parameters
Evaluated using the Zebris system. Includes gait speed (m/s), cadence (steps/min), stride length (cm), stance percentage (%), and plantar pressure parameters (e.g., peak pressure, contact area).
Measured: Baseline and 8 Weeks
Secondary outcomes (3)
Numeric Pain Rating Scale (NPRS)
Assesses pain intensity on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Baseline and 8 Weeks
36-Item Short Form Health Survey (SF-36)
Assesses health-related quality of life across 8 domains. Subscale scores are transformed to a 0 to 100 scale, where higher scores indicate better health status.
Measured: Baseline and 8 Weeks
6-Minute Walk Test (6MWT) and Modified Borg Scale
Evaluates functional capacity by measuring the total distance walked in 6 minutes (in meters). Perceived exertion is assessed before and after the test using the Modified Borg Scale (0-10 scale; higher scores indicate greater exertion).
Measured: Baseline and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start26 Oct 2026
- Primary completion26 Oct 2027 (estimated)
- Study completion26 Dec 2027 (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 Kutahya Health Sciences 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Afsar, Kutahya Health Sciences University
- Investigators
- Emrah Afsar, Phd, Principal investigator, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895602
- Sponsor's protocol ID
- 3D Insole in Pes Planus
- Other IDs
- TDK-2026-365
- Status last verified
- Nov 2026
- First submitted
- 19 Oct 2026
- Last updated
- 5 Nov 2026
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Custom 3D Printed Insoles and Short Foot Exercises on Foot Posture, Balance, and Gait Parameters in Individuals With Pes Planus
- ClinicalTrials.gov ID
- NCT07895602
- Acronym / sponsor ID
- 3D Insole in Pes Planus
- Conditions
- Pes Planus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 26 Oct 2027 (estimated)
- Study completion
- 26 Dec 2027 (estimated)
- First posted
- 26 Oct 2026 (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 primary purpose of this study is to evaluate the effects of combining custom 3D-printed medial arch-supported insoles with short foot exercises on foot posture, balance, and gait parameters in individuals with pes planus (flat feet). Furthermore, the study will investigate the impact of this combined intervention on secondary outcomes, including pain levels, health-related quality of life, and functional exercise capacity measured by the 6-Minute Walk Test.
Detailed description
Participants will be recruited through personal networks and social media platforms using a snowball sampling method. Potential candidates will be screened for pes planus in accordance with established literature protocols, utilizing the Foot Posture Index-6 (FPI-6) and the Navicular Drop Test.
Eligible individuals who meet the criteria for pes planus will undergo 3D foot scanning. Based on the obtained data, customized medial arch-supported insoles will be manufactured using 3D printing technology. Participants will be instructed to use these custom insoles in their daily lives for a total of 8 weeks. Concurrently, they will be assigned a daily short foot exercise (intrinsic muscle training) program. Each exercise repetition will involve a 5-second hold, and the entire protocol will be maintained for 8 weeks.
All clinical, functional, and biomechanical evaluations-including foot posture, dynamic balance, comprehensive gait and plantar pressure analysis (via the Zebris system), pain intensity, quality of life, and functional walking capacity-will be conducted at two time points: at baseline and at the end of the 8-week intervention period.
For statistical analysis, depending on the normality of data distribution, either a paired t-test or a Wilcoxon signed-rank test will be used to evaluate within-group changes between baseline and week 8. To determine the magnitude of the intervention effect, Cohen's d effect sizes for dependent measures will be calculated and reported alongside 95% confidence intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insole and Exercise Group | Experimental | Other: Custom 3D Printed Insoles and Short Foot ExercisesAll participants in this group will receive custom 3D printed insoles and perform a short foot exercise program. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18 and 35 years.
- Presence of pes planus, defined as a Navicular Drop test value > 10 mm and a Foot Posture Index-6 (FPI-6) score between +6 and +12.
- Willingness to volunteer for the study and provide written informed consent.
Key exclusion criteria (8 listed)
- Presence of rigid pes planus.
- Hallux valgus.
- Hallux rigidus.
- Calcaneal spur (heel spur).
- History of any neurological, cardiovascular, or systemic diseases.
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 |
|---|---|---|
| Custom 3D Printed Insoles and Short Foot ExercisesThe intervention consists of a combined biomechanical and active rehabilitation approach for individuals with pes planus: 1. Custom 3D Printed Insoles: The participants' feet will be 3D scanned, and custom insoles will be manufactured using 3D printing technology. Participants will be recommended to use these personalized insoles during their daily activities for a total of 8 weeks. 2. Short Foot Exercises (SFE): Participants will perform a short foot exercise (foot core / intrinsic muscle) program aimed at increasing intrinsic foot muscle activation. The exercise protocol will be performed daily for 8 weeks, with each repetition held for five seconds. | Other | Insole and Exercise Group |
Primary outcome
Foot Posture Index-6 (FPI-6)
Time frame: Baseline and 8 Weeks
Assesses foot posture across 6 criteria. Total scores range from -12 (highly supinated) to +12 (highly pronated).
Navicular Drop Test (NDT)
Time frame: Baseline and 8 Weeks
Assesses medial longitudinal arch height difference (in mm) between seated (non-weight bearing) and standing (weight bearing) positions. Higher values indicate increased pronation.
Modified Star Excursion Balance Test (MSEBT)
Time frame: Baseline and 8 Weeks
Evaluates dynamic balance by measuring the maximum reach distance (in cm) in three directions: anterior, posteromedial, and posterolateral.
Spatiotemporal Gait and Plantar Pressure Parameters
Time frame: Baseline and 8 Weeks
Evaluated using the Zebris system. Includes gait speed (m/s), cadence (steps/min), stride length (cm), stance percentage (%), and plantar pressure parameters (e.g., peak pressure, contact area).
3 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline and 8 Weeks
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline and 8 Weeks
6-Minute Walk Test (6MWT) and Modified Borg Scale
Time frame: Baseline and 8 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Related trials for 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
Not yet recruiting
Comparison Between Foot Segment Mulligan Mobilization and Ilium Mulligan Mobilization in Treatment Patellofemoral Pain Patients With Flatfeet: a Randomized Controlled Comparative Study
Patellofemoral Pain, PFP, Flatfeet
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.
Emrah Afsar, Phd principal investigator
Kutahya Health Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom 3D Printed Insoles and Short Foot Exercises in people with Pes Planus, run by Kutahya Health Sciences 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emrah Afsar, Phd (5062527008, emrah.afsar@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Posture Index-6 (FPI-6) (time frame: Baseline and 8 Weeks). The study lists 4 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 5 Nov 2026.