Flat Foot [Pes Planus] (Acquired), Unspecified FootNCT05306886
Investigation of the Effect of Specially Designed Insoles for Flat-footed Patients
A study testing ICB Medical Insoles and ICM Insoles in people with Flat Foot [Pes Planus] (Acquired), Unspecified Foot, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
In our study, it was aimed to investigate the effect of insoles specially designed for each patient and printed with 3D printers on the physical activity levels, balance and functional performances of those patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Flat Foot [Pes Planus] (Acquired), Unspecified Foot
- What is being tested?
- ICB Medical Insoles and ICM Insoles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 16 Jun 2023
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Having a minimum 5 degree subtalar pronation angle while standing,
- 2. A minimum score of +6 from the Foot Posture Index (API) scale
- 3. Being between the ages of 18-45
- 4. Not having received any treatment from the foot area in the last 6 months
- 5. To have cognitive competence
Who cannot join
- 1. End of volunteering
- 2. Having a history of surgery of the lower extremity
- 3. Being an active athlete
- 4. Being pregnant or diagnosed with malignancy
- 5. Having a dysfunction such as severe neurological involvement, immobility, cooperation deficits that will limit physical activity
- 6. Lower extremity inequality greater than 1 centimeter (cm)
- 7. Having a different orthopedic disease that may affect lower extremity biomechanics
- 8. Receiving a different treatment for pes planus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University Faculty of Health Science
Bolu, Merkez, 14100
About this study
Official title: Investigation of the Effect of Specially Designed and 3D Printed Insoles on Physical Activity Levels, Balance and Functional Performances
In our study, it was aimed to investigate the effect of insoles specially designed for each patient and printed with 3D printers on the physical activity levels, balance and functional performances of those patients.
Read the detailed description
Our study, B.A.İ.B.Ü. İzzet Baysal Physical Therapy Training and Research Hospital and Fizyotermal Corp. It will be carried out as a dual center on individuals between the ages of 18-45 who apply to our clinic. It will be carried out by selecting 48 people who are suitable for the study among the flat-footed patients who applied to the clinics.
Patients will be evaluated before they start using the insoles, and immediately after using it , also after wearing the insoles for 8 weeks.
Patients will be randomized according to the order of their arrival at the clinic.
- Being tested
- ICB Medical Insoles, ICM Insoles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICB Medical InsolesOther
After the foot analysis of the participants in the intervention group, special insoles will be designed in a computer program. In these insoles, 3-6 mm medial wedge support, 1-3 mm heel wedge support, 2-4 mm medial longitudinal arch support will be provided. These values will be determined according to the needs of each participant. A single physiotherapist will design all insoles. All drawings will be made by a single physiotherapist. After the design of the insoles is completed, insoles will be produced by transferring them to a Computer Numerical Control (CNC) machine. Ethyl vinyl acetate (EVA), the use of which has been found useful before, will be used as the material in the insoles molds. After processing, 1mm thick fabric will be used for the top coating. All insoles will be produced by the same physiotherapist.
ICM InsolesOther
As in the intervention group, insoles will be designed for the participants in the control group, processed by CNC machine and the production will be completed. Only 2mm medial longitudinal arch support will be given to the insoles of the people in this group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | ICB Special Insoles Receives: Other: ICB Medical Insoles |
| Control group | Active comparator | ICB Insoles Receives: Other: ICM Insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Physical Activity Assessment Questionnaire (IPAQ) Short Form
This form will be used to measure physical activity levels. comprises a set of 4 questionnaires.
Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity. Higher scores indicates better physical activity level.
Measured: Eight weeks
Flamingo Balance Test and Y Balance Test
This will be applied for balance evaluation.To assess the ability to balance successfully on a single leg. A stopwatch, metal beam 50cm long, 5cm high and 3cm wide needed for test procedure. The total number of falls or loss of balance in 60 seconds is recorded. Scoring tables are available in the Eurofit Manual.
Measured: Eight weeks
Secondary outcomes (3)
Standing Long Jump Test
For functional performance Standing Long Jump test will be applied.The athlete stands behind a line marked on the ground with feet slightly apart. A two foot take¬off and landing is used, with swinging of the arms and bending of the knees to provide forward drive. The subject attempts to jump as far as possible, landing on both feet without falling backwards. Three attempts are allowed. The measurement is taken from take¬off line to the nearest point of contact on the landing (back of the heels). Record the longest distance jumped, the best of three attempts. The table below gives a rating scale for the standing long jump test for adults, based on personal experiences.
Measured: Eight weeks
10 Meter Walk Test
For functional performance10 Meter Walk test will be applied. Patient's will be asked to walk 10 meter. Time is measured while patients walk.
Measured: Eight weeks
Shuttle Running Test
For functional performance Shuttle Running Test will be applied. his test requires the person to run back and forth between two parallel lines as fast as possible. Set up two lines of cones 30 feet apart or use line markings, and place two blocks of wood or a similar object behind one of the lines.Two or more trails may be performed, and the quickest time is recorded. Results are recorded to the nearest tenth of a second.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Mar 2022
- Primary completion15 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat Foot [Pes Planus] (Acquired), Unspecified FootStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Ramazan Kurul, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306886
- Sponsor's protocol ID
- AIBU-FTR-BENLI-003
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2022
- Last updated
- 22 Apr 2024
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Specially Designed and 3D Printed Insoles on Physical Activity Levels, Balance and Functional Performances
- ClinicalTrials.gov ID
- NCT05306886
- Acronym / sponsor ID
- AIBU-FTR-BENLI-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 1 Apr 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.
In our study, it was aimed to investigate the effect of insoles specially designed for each patient and printed with 3D printers on the physical activity levels, balance and functional performances of those patients.
Detailed description
Our study, B.A.İ.B.Ü. İzzet Baysal Physical Therapy Training and Research Hospital and Fizyotermal Corp. It will be carried out as a dual center on individuals between the ages of 18-45 who apply to our clinic. It will be carried out by selecting 48 people who are suitable for the study among the flat-footed patients who applied to the clinics.
Patients will be evaluated before they start using the insoles, and immediately after using it , also after wearing the insoles for 8 weeks.
Patients will be randomized according to the order of their arrival at the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: ICB Medical InsolesICB Special Insoles |
| Control group | Active comparator | Other: ICM InsolesICB Insoles |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Having a minimum 5 degree subtalar pronation angle while standing,
- 2. A minimum score of +6 from the Foot Posture Index (API) scale
- 3. Being between the ages of 18-45
- 4. Not having received any treatment from the foot area in the last 6 months
- 5. To have cognitive competence
Key exclusion criteria (8 listed)
- 1. End of volunteering
- 2. Having a history of surgery of the lower extremity
- 3. Being an active athlete
- 4. Being pregnant or diagnosed with malignancy
- 5. Having a dysfunction such as severe neurological involvement, immobility, cooperation deficits that will limit physical activity
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 |
|---|---|---|
| ICB Medical InsolesAfter the foot analysis of the participants in the intervention group, special insoles will be designed in a computer program. In these insoles, 3-6 mm medial wedge support, 1-3 mm heel wedge support, 2-4 mm medial longitudinal arch support will be provided. These values will be determined according to the needs of each participant. A single physiotherapist will design all insoles. All drawings will be made by a single physiotherapist. After the design of the insoles is completed, insoles will be produced by transferring them to a Computer Numerical Control (CNC) machine. Ethyl vinyl acetate (EVA), the use of which has been found useful before, will be used as the material in the insoles molds. After processing, 1mm thick fabric will be used for the top coating. All insoles will be produced by the same physiotherapist. | Other | Intervention group |
| ICM InsolesAs in the intervention group, insoles will be designed for the participants in the control group, processed by CNC machine and the production will be completed. Only 2mm medial longitudinal arch support will be given to the insoles of the people in this group. | Other | Control group |
Primary outcome
The Physical Activity Assessment Questionnaire (IPAQ) Short Form
Time frame: Eight weeks
This form will be used to measure physical activity levels. comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity. Higher scores indicates better physical activity level.
Flamingo Balance Test and Y Balance Test
Time frame: Eight weeks
This will be applied for balance evaluation.To assess the ability to balance successfully on a single leg. A stopwatch, metal beam 50cm long, 5cm high and 3cm wide needed for test procedure. The total number of falls or loss of balance in 60 seconds is recorded. Scoring tables are available in the Eurofit Manual.
3 secondary outcomes
Standing Long Jump Test
Time frame: Eight weeks
10 Meter Walk Test
Time frame: Eight weeks
Shuttle Running Test
Time frame: Eight weeks
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 22 Apr 2024.
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.
Ramazan Kurul principal investigator
Abant Izzet Baysal 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 ICB Medical Insoles and ICM Insoles in people with Flat Foot [Pes Planus] (Acquired), Unspecified Foot, run by Abant Izzet Baysal 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 5 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: finished, as of the sponsor's last update on 22 Apr 2024. 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?
The Physical Activity Assessment Questionnaire (IPAQ) Short Form (time frame: Eight weeks). The study lists 2 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 22 Apr 2024.