NCT06034600

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

October 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

March 21, 2023

Last Update Submit

October 5, 2024

Conditions

Keywords

exerciseflat footAugmented Low-dyenavicular dropplantar pressure

Outcome Measures

Primary Outcomes (1)

  • foot plantar pressure

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

    baseline, at 8 and 12 weeks

Secondary Outcomes (2)

  • navicular drop

    baseline, at 8 and 12 weeks

  • foot posture index

    baseline, at 8 and 12 weeks

Study Arms (2)

exercise and taping

EXPERIMENTAL

Individuals in this group are planned to practice exercise together with taping therapy for eight weeks.

Other: tapingOther: exercise

exercise

EXPERIMENTAL

Individuals in this group are planned to receive only exercise practice for eight weeks.

Other: exercise

Interventions

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.

exercise and taping

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.

exerciseexercise and taping

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu Univercity

Malatya, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

FlatfootMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Burcu Talu, PhD

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental, single-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2023

First Posted

September 13, 2023

Study Start

October 6, 2023

Primary Completion

April 15, 2024

Study Completion

November 1, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations