Pes PlanusAldNCT06034600
Effect of Augmented Low-dye* Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus
A study testing taping and exercise in people with Pes Planus, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Pes planus is a deformity that affects the foot-ankle muscle complex as well as passive components of the foot such as bones and ligaments. Various approaches such as taping methods and exercise training are being investigated in the treatment of pes planus. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pes Planus
- What is being tested?
- taping and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2023to 1 Nov 2024
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18-25
- Navicular drop (ND) test >10 mm
- Foot posture index ≥6
- Individuals in the 1st and 2nd category according to the international physical activity survey
- Individuals who volunteered to participate in the study
Who cannot join
- Presence of systemic, neurological, rheumatological or orthopedic problems that may affect the lower extremity
- Individuals who are allergic to the tape to be used
- Individuals who cannot adapt to exercise or taping practices
- Individuals who have received treatment for pes planus in the last 6 months
- Individuals with a BMI ≥ 30
- Presence of pregnancy
- Cases not wanting to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Augmented Low-dye Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus
Introduction: Pes planus is a deformity that affects the foot-ankle muscle complex as well as passive components of the foot such as bones and ligaments. Various approaches such as taping methods and exercise training are being investigated in the treatment of pes planus. The effect of the applied methods and their superiority over each other are still unclear. The effect of banding methods varies according to the band type and technique. Exercise methods currently focus on the intrinsic and extrinsic muscles of the foot. Pedobarographic evaluations are also performed in addition to clinical evaluations to evaluate the effectiveness of treatments.
Objective: It is planned to compare the effects of reinforced low-dye taping method, which is one of the rigid taping techniques used in the treatment of pes planus, and exercise training on foot plantar pressure, navicular drop and foot posture.
Read more
Material and method: 34 individuals with pes planus between the ages of 18-25 will be included in the study, which was designed as a single-blind randomized study. The universe of our study will be Lokman Hekim University Faculty of Health Sciences and Institute of Health Sciences. The whole universe will be tried to be reached and individuals who meet the inclusion criteria will be selected from the relevant universe. Consent form will be obtained from individuals who are deemed eligible to participate in the study. Pes planus evaluation; It will be done using the navicular drop test and the foot posture index. In order for the physical activity levels of the groups to be homogeneous, after stratified sampling, individuals will be randomly assigned to the exercise groups by taping and exercise with the closed envelope method. Evaluations will be made to each group at the beginning, at the eighth and twelfth week. Static evaluation of the foot will be made using navicular drop and foot posture index, and pedobarographic analysis will be done using a foot analyzer.
Conclusion: The effects of taping and exercise training on foot static and plantar pressure measurements will be interpreted.
Read the detailed description
For taping application, intermittent taping will be done by the same researcher on the foot with pes planus three times a week. The applied hard taping technique will be applied continuously for eight weeks. The group that will perform exercises together with the taping treatment will perform the exercises with the resistance band without taping and then do the other exercises after the taping application. The applied taping will remain on the skin as long as it can until the next taping day. Individuals will be asked to note the length of stay of the tape on the skin. The exercises will be done three days a week for eight weeks. After verbal information about the research protocol to be applied, practical training will be given for the exercises. In the banding application, reinforced low-dye (ALD) technique, one of the hard banding techniques, will be applied. A hard tape will be used on the individuals by the same researcher throughout the study. With the tape application, to the participants; Information will be given about physical activity, shoes and issues that should be considered in daily life.
- Conditions
- Pes Planus
- Being tested
- taping, exercise
- Keywords
- exercise, flat foot, Augmented Low-dye, navicular drop, plantar pressure
- 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.
tapingOther
Taping will be applied to the exercise and taping group after the exercises with theraband. Other exercises that are not performed will be performed with the tape on the skin.The application will be repeated three days a week for eight weeks.
exerciseOther
Stretching and strengthening exercises will be applied to both groups three days a week for 8 weeks.The exercises performed with theraband will be performed in the same way in both groups. While the other exercises will be done after taping in the "taping and exercise group", the "exercise group" will be done without taping.
| Study group | Role | What they receive |
|---|---|---|
| exercise and taping | Experimental | Individuals in this group are planned to practice exercise together with taping therapy for eight weeks. Receives: Other: taping; Other: exercise |
| exercise | Experimental | Individuals in this group are planned to receive only exercise practice for eight weeks. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
foot plantar pressure
A foot analyzer will be used in the pedobarographic evaluation of the foot.
Measured: baseline, at 8 and 12 weeks
Secondary outcomes (2)
navicular drop
The distance measurement from the ground with the navicular will be measured using the caliper. Three measurements will be taken and the average recorded.
Measured: baseline, at 8 and 12 weeks
foot posture index
Each criterion is scored on a scale ranging from -2 to +2, when the score is between 0 and 5, the foot will be considered neutral and between 6 and +12 as pronation.
Measured: baseline, at 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start6 Oct 2023
- Primary completion15 Apr 2024
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Model description
- Experimental, single-blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Oren, Inonu University
- Investigators
- Burcu Talu, PhD, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034600
- Sponsor's protocol ID
- 2022/4027
- Other IDs
- 0000-0002-5941-1619
- Acronym
- Ald
- Status last verified
- Oct 2024
- First submitted
- 21 Mar 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang M, Wang L, You Y, Li J, Hu X. Effects of taping techniques on arch deformation in adults with pes planus: A meta-analysis. PLoS One. 2021 Jul 2;16(7):e0253567. doi: 10.1371/journal.pone.0253567. eCollection 2021.
PubMed 34214104Hoang NT, Chen S, Chou LW. The Impact of Foot Orthoses and Exercises on Pain and Navicular Drop for Adult Flatfoot: A Network Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 29;18(15):8063. doi: 10.3390/ijerph18158063.
PubMed 34360354
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Augmented Low-dye Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus
- ClinicalTrials.gov ID
- NCT06034600
- Acronym / sponsor ID
- Ald / 2022/4027
- Conditions
- Pes Planus
- Keywords
- exercise, flat foot, Augmented Low-dye, navicular drop, plantar pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 13 Sep 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.
Introduction: Pes planus is a deformity that affects the foot-ankle muscle complex as well as passive components of the foot such as bones and ligaments. Various approaches such as taping methods and exercise training are being investigated in the treatment of pes planus. The effect of the applied methods and their superiority over each other are still unclear. The effect of banding methods varies according to the band type and technique. Exercise methods currently focus on the intrinsic and extrinsic muscles of the foot. Pedobarographic evaluations are also performed in addition to clinical evaluations to evaluate the effectiveness of treatments.
Objective: It is planned to compare the effects of reinforced low-dye taping method, which is one of the rigid taping techniques used in the treatment of pes planus, and exercise training on foot plantar pressure, navicular drop and foot posture.
Material and method: 34 individuals with pes planus between the ages of 18-25 will be included in the study, which was designed as a single-blind randomized study. The universe of our study will be Lokman Hekim University Faculty of Health Sciences and Institute of Health Sciences. The whole universe will be tried to be reached and individuals who meet the inclusion criteria will be selected from the relevant universe. Consent form will be obtained from individuals who are deemed eligible to participate in the study. Pes planus evaluation; It will be done using the navicular drop test and the foot posture index. In order for the physical activity levels of the groups to be homogeneous, after stratified sampling, individuals will be randomly assigned to the exercise groups by taping and exercise with the closed envelope method. Evaluations will be made to each group at the beginning, at the eighth and twelfth week. Static evaluation of the foot will be made using navicular drop and foot posture index, and pedobarographic analysis will be done using a foot analyzer.
Conclusion: The effects of taping and exercise training on foot static and plantar pressure measurements will be interpreted.
Detailed description
For taping application, intermittent taping will be done by the same researcher on the foot with pes planus three times a week. The applied hard taping technique will be applied continuously for eight weeks. The group that will perform exercises together with the taping treatment will perform the exercises with the resistance band without taping and then do the other exercises after the taping application. The applied taping will remain on the skin as long as it can until the next taping day. Individuals will be asked to note the length of stay of the tape on the skin. The exercises will be done three days a week for eight weeks. After verbal information about the research protocol to be applied, practical training will be given for the exercises. In the banding application, reinforced low-dye (ALD) technique, one of the hard banding techniques, will be applied. A hard tape will be used on the individuals by the same researcher throughout the study. With the tape application, to the participants; Information will be given about physical activity, shoes and issues that should be considered in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental, single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| exercise and taping | Experimental | Other: taping, Other: exerciseIndividuals in this group are planned to practice exercise together with taping therapy for eight weeks. |
| exercise | Experimental | Other: exerciseIndividuals in this group are planned to receive only exercise practice for eight weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be between the ages of 18-25
- Navicular drop (ND) test >10 mm
- Foot posture index ≥6
- Individuals in the 1st and 2nd category according to the international physical activity survey
- Individuals who volunteered to participate in the study
Key exclusion criteria (7 listed)
- Presence of systemic, neurological, rheumatological or orthopedic problems that may affect the lower extremity
- Individuals who are allergic to the tape to be used
- Individuals who cannot adapt to exercise or taping practices
- Individuals who have received treatment for pes planus in the last 6 months
- Individuals with a BMI ≥ 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 |
|---|---|---|
| tapingTaping will be applied to the exercise and taping group after the exercises with theraband. Other exercises that are not performed will be performed with the tape on the skin.The application will be repeated three days a week for eight weeks. | Other | exercise and taping |
| exerciseStretching and strengthening exercises will be applied to both groups three days a week for 8 weeks.The exercises performed with theraband will be performed in the same way in both groups. While the other exercises will be done after taping in the "taping and exercise group", the "exercise group" will be done without taping. | Other | exercise, exercise and taping |
Primary outcome
foot plantar pressure
Time frame: baseline, at 8 and 12 weeks
A foot analyzer will be used in the pedobarographic evaluation of the foot.
2 secondary outcomes
navicular drop
Time frame: baseline, at 8 and 12 weeks
foot posture index
Time frame: baseline, at 8 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Results publication: PubMed 34214104Tang M, Wang L, You Y, Li J, Hu X. Effects of taping techniques on arch deformation in adults with pes planus: A meta-analysis. PLoS One. 2021 Jul 2;16(7):e0253567. doi: 10.1371/journal.pone.0253567. eCollection 2021.
- Results publication: PubMed 34360354Hoang NT, Chen S, Chou LW. The Impact of Foot Orthoses and Exercises on Pain and Navicular Drop for Adult Flatfoot: A Network Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 29;18(15):8063. doi: 10.3390/ijerph18158063.
- Individual participant dataSharing planned: No
Related trials for Pes Planus
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
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
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.
Burcu Talu, PhD study director
Inonu 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 taping and exercise in people with Pes Planus, run by Inonu 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 7 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 9 Oct 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?
Results are not available in the source record.
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 plantar pressure (time frame: baseline, at 8 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06034600, which also lists 2 linked publications.
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 9 Oct 2024.