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

Primary Purpose

Pes Planus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
taping
exercise
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pes Planus focused on measuring exercise, flat foot, Augmented Low-dye, navicular drop, plantar pressure

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    exercise and taping

    exercise

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    March 21, 2023
    Last Updated
    September 14, 2023
    Sponsor
    Inonu University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06034600
    Brief Title
    Effect of Augmented Low-dye* Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus
    Acronym
    Ald
    Official Title
    Effect of Augmented Low-dye Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 6, 2023 (Anticipated)
    Primary Completion Date
    July 15, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Inonu University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pes Planus
    Keywords
    exercise, flat foot, Augmented Low-dye, navicular drop, plantar pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Experimental, single-blind randomized controlled trial
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    exercise and taping
    Arm Type
    Experimental
    Arm Description
    Individuals in this group are planned to practice exercise together with taping therapy for eight weeks.
    Arm Title
    exercise
    Arm Type
    Experimental
    Arm Description
    Individuals in this group are planned to receive only exercise practice for eight weeks.
    Intervention Type
    Other
    Intervention Name(s)
    taping
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    foot plantar pressure
    Description
    A foot analyzer will be used in the pedobarographic evaluation of the foot.
    Time Frame
    baseline, at 8 and 12 weeks
    Secondary Outcome Measure Information:
    Title
    navicular drop
    Description
    The distance measurement from the ground with the navicular will be measured using the caliper. Three measurements will be taken and the average recorded.
    Time Frame
    baseline, at 8 and 12 weeks
    Title
    foot posture index
    Description
    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.
    Time Frame
    baseline, at 8 and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    asli oren, Msc
    Phone
    05065321333
    Email
    fztaslioren@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Burcu Talu, PhD
    Organizational Affiliation
    Inonu University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34214104
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    34360354
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

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