Immediate Effects of Kinesio Taping and Manual Release in Young Adults With Pes Planus

April 6, 2022 updated by: Ertuğrul Demirdel, Ankara Yildirim Beyazıt University

Investigation of the Immediate Effects of Kinesio Taping and Manual Release on Lower Extremity Performance in Young Adults With Pes Planus

Pes planus is a postural deformity seen with decreased medial longitudinal arch (MLA) height and this causes intense stress on the plantar fascia. Pes planus may affect individuals' activities of daily living, their productivity in occupational environments, and the risk of injury and performance in sports; It has also been reported that it may cause different musculoskeletal diseases such as plantar fasciitis, medial tibial stress syndrome, patellofemoral disorders and back pain in the future. Many clinical methods are used as a treatment for pes planus and most treatments involve supporting an overstretched plantar fascia and weakened MLA. The aim of the study is to investigate the immediate effects of kinesio taping and manual release on lower extremity performance in young adults with pes planus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a randomized controlled trial, will be carried out on volunteer individuals with pes planus aged between 18-25, studying at Ankara Yıldırım Beyazıt University. Evaluation of parameters and inclusion criteria, kinesio taping and manual release applications will be made by the Physiotherapist. Individuals who meet the inclusion criteria, who volunteered to participate in the study and signed the consent sheet will be randomly divided into two groups, Group 1 [Manual Release (MR)] and Group 2 [Kinesio Taping (KT)]. A simple randomization method will be used with opaque sealed envelopes containing "1" or "2". Group allocation will be performed by an independent therapist, not involved in the study. All individuals will be evaluated with timed up-and-go test, heel rise test, 10-meter walking test, and functional reach test before and after the intervention. Manual release will be applied to group 1 after the evaluation and the evaluations will be repeated immediately the end of the application. Kinesio taping will be applied to group 2 after the evaluation and the evaluations will be repeated 45 minutes after the end of the application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals who volunteer to participate in the study
  • Individuals with bilateral pes planus
  • Individuals who have not had any ankle injury in the last 6 months

Exclusion Criteria:

  • Individuals with severe visual and hearing impairment
  • Individuals with congenital shortness or deformity in their lower extremities
  • Individuals who have had any lower extremity surgery
  • Individuals with hallux valgus, hallux rigidus, or calcaneal epine
  • Individuals with any musculoskeletal problem other than pes planus and systemic, neurological problems
  • Individuals with chronic ankle instability
  • Individuals who have had problems walking for the last 6 months
  • Individuals who have received treatment for pes planus in the last 6 months and use insoles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Manual release group
Manual release will perform with plantar fascia and flexor hallucis longus stretching and tissue mobilization. Stretching/mobilization will applied for approximately 3 minutes.
Other: Manual Release
Individuals are placed in the prone position with their knees extended. The calcaneus is kept in eversion while maintaining talocrural dorsiflexion. As the toes are stretched in dorsiflexion, the therapist slides the big toe distally and proximally along the plantar fascia and flexor hallucis longus. Soft tissue mobilization depth will be applied according to the patient's tolerance and reactivity.
EXPERIMENTAL: Kinesio taping group
Two techniques will be used in kinesio taping application; first technique is the gastrocnemius muscle inhibition technique and the plantar fascia ligament correction technique and other technique is the transverse arch ligament correction technique.
Other: Kinesio Taping
In the first technique, an "I" tape will be applied on the plantar surface of the foot from the metatarsal heads to the popliteal fossa. First, the middle of the band is attached to the inferior of the calcaneus as the first anchor, then the ankle is dorsiflexed and the upper part of the band is applied with 15-25% tension until the popliteal fossa. The plantar fascia is placed in a stretched position by dorsiflexing the ankle and fingers, and the ends of the tape, which is divided into 4 parts, are applied separately to the metatarsal heads with 75-100% tension. In the second technique, the application is made with an "I" tape. The initial anchor starts from the dorsal aspect of the 5th metatarsal on the lateral aspect of the foot. Then, the tape passes to the medial side of the foot with 75-100% tension and is adhered to the medial side of the foot and ankle over the navicular. The end anchor is applied without tension.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Timed up and go test (TUG)
Time Frame: Change from baseline at immediately after one-session treatment
The timed up and go test is used to assess functional mobility. The test involves getting up from a standard chair without armrests, walking around a cone 3 m in front of the chair, and returning to the original sitting position as quickly as possible without running. The test is started with the researcher's verbal "go" instruction and the time to complete the test is recorded. After a familiarization attempt, three recorded exercises are performed with one-minute rest intervals. The fastest of three attempts is saved.
Change from baseline at immediately after one-session treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heel rise test (HRT)
Time Frame: Change from baseline at immediately after one-session treatment
The endurance of the gastro-soleus muscle complex is evaluated with the heel rise test. The number of toe-ups in one minute is determined when the knees of the subjects are in extension. The results are recorded as the number of repetitions.
Change from baseline at immediately after one-session treatment
10 meter walk test, walking speed
Time Frame: Change from baseline at immediately after one-session treatment
Walking speed is evaluated with the 10 meter walking test. The test is performed at a comfortable walking pace on a 10 m walk, 14 m walkway for the start (2 m) and finish (2 m). Measurements are repeated 3 times and the average time is recorded in seconds.
Change from baseline at immediately after one-session treatment
10 meter walk test, cadence
Time Frame: Change from baseline at immediately after one-session treatment
Cadence is evaluated with the 10 meter walking test. The test is performed at a comfortable walking pace on a 10 m walk, 14 m walkway for the start (2 m) and finish (2 m). During the 10-meter walk, the number of steps is recorded.
Change from baseline at immediately after one-session treatment
Functional reach test (FUT)
Time Frame: Change from baseline at immediately after one-session treatment
Balance is assessed with the functional reach test. In the application of the test, the individual is asked to keep his feet open and close to a parallel shoulder-width wall. The individual have a measuring stick attached to the wall at shoulder level. The individual is asked to punch his hand and flex his shoulder 90 degrees without touching the wall, and bring the third metacarpal finger joint of his hand to the starting point of the measuring stick.The individual is guided to reach as far as possible without taking a step, without lifting his heels, without bending his knees, and the end point is recorded. The difference between the starting position and the ending position is measured in cm. The test is repeated three times and the average of the three measurements is recorded.
Change from baseline at immediately after one-session treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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