- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06034600
Effect of Augmented Low-dye* Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus (Ald)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: asli oren, Msc
- Phone Number: 05065321333
- Email: fztaslioren@hotmail.com
Study Locations
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Malatya, Turkey
- Inonu Univercity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: exercise and taping
Individuals in this group are planned to practice exercise together with taping therapy for eight weeks.
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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.
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.
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Experimental: exercise
Individuals in this group are planned to receive only exercise practice for eight weeks.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
foot plantar pressure
Time Frame: baseline, at 8 and 12 weeks
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A foot analyzer will be used in the pedobarographic evaluation of the foot.
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baseline, at 8 and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
navicular drop
Time Frame: baseline, at 8 and 12 weeks
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The distance measurement from the ground with the navicular will be measured using the caliper.
Three measurements will be taken and the average recorded.
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baseline, at 8 and 12 weeks
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foot posture index
Time Frame: baseline, at 8 and 12 weeks
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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.
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baseline, at 8 and 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Burcu Talu, PhD, Inonu University
Publications and helpful links
General 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.
- Hoang 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/4027
- 0000-0002-5941-1619 (Other Identifier: Orcid)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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