Effect of Augmented Low-dye* Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus (Ald)

• ClinicalTrials.gov Identifier: NCT06034600
• Recruitment Status: Active, not recruiting
• First Posted: September 13, 2023
• Last Update Posted: March 6, 2024
• Sponsor: Inonu University
• Information provided by (Responsible Party): Asli Oren, Inonu University

Tracking Information

• First Submitted Date: March 21, 2023
• First Posted Date: September 13, 2023
• Last Update Posted Date: March 6, 2024
• Actual Study Start Date: October 6, 2023
• Estimated Primary Completion Date: April 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2023)

foot plantar pressure [ Time Frame: baseline, at 8 and 12 weeks ]

A foot analyzer will be used in the pedobarographic evaluation of the foot.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2023)

• navicular drop [ Time Frame: baseline, at 8 and 12 weeks ]
  The distance measurement from the ground with the navicular will be measured using the caliper. Three measurements will be taken and the average recorded.
• foot posture index [ Time Frame: baseline, at 8 and 12 weeks ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Augmented Low-dye* Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus
• Official Title: Effect of Augmented Low-dye Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus

Brief 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. 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Experimental, single-blind randomized controlled trial

Masking: Single (Participant)
Primary Purpose: Treatment

• Condition: Pes Planus

Intervention

• Other: taping
  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.
• Other: exercise
  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 Arms

• Experimental: exercise and taping
  Individuals in this group are planned to practice exercise together with taping therapy for eight weeks.
  Interventions:

  • Other: taping
  • Other: exercise
• Experimental: exercise
  Individuals in this group are planned to receive only exercise practice for eight weeks.
  Intervention: Other: exercise

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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 6, 2023): 34
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2024
• Estimated Primary Completion Date: April 15, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 25 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT06034600
• Other Study ID Numbers: 2022/4027; 0000-0002-5941-1619 ( Other Identifier: Orcid )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Asli Oren, Inonu University
• Original Responsible Party: Asli Oren, Inonu University, Msc
• Current Study Sponsor: Inonu University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Burcu Talu, PhD; Inonu University

• PRS Account: Inonu University
• Verification Date: March 2024