The Effect of Kinesio Taping on q Angle and Pes Planus in Children With Cerebral Palsy

November 13, 2023 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
The aim of our study is to examine the effect of using kinesiology tape and using it for 8 weeks on Q angle and pes planus on children with cerebral palsy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

At the beginning of the study, the pes planus level of the children will be determined. Then randomization will be made and divided into 3 groups with equal number of participants. The groups will be called control, experiment, and placebo. Only physiotherapy will be applied to the control group, kinesio taping and physiotherapy to the experimental group, and damask taping and physiotherapy to the placebo group. The study will be followed for 8 weeks, and pre- and post-intervention data were statistically analyzed and compared.

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 (Actual)

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.
45

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • İstanbul
      • Üsküdar, İstanbul, Turkey
        • Üsküdar Unıversıty

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being diagnosed with cerebral palsy
  • Gross Motor Function Classification System level 1,2 and 3
  • 2-18 years

Exclusion Criteria:

  • Having Gross Motor Function Classification System levels 4 and 5
  • Those with genetic and metabolic diagnosis

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 Assignment
  • Masking: Single

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.
Active Comparator: control group
In the control group, only the exercise program was applied and the first and last measurements will be compared.
Other: exercise

Exercise protocol:

Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching
Experimental: experimental group
In the experimental group, kinesiology taping will be applied twice a week for 8 weeks together with exercise. Kinesiology taping was first applied by closing the malleoli from the upper part of the foot, and stretching it to the anterior capsule of the foot using the ligament technique. For the second tape, it covered the plantar area under the malleolus and was attached in the form of stirrups. During the application, the tape will be applied with full tension on the malleolus and 50-75% tension will be applied on the other parts.
Other: exercise

Exercise protocol:

Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching

Other: exercise and taping
When applying kinesiology taping to the gluteus medius, first of all, for its anterior fiber, the tape portion will be attached lateral to the Spina iliaca anterior superior by giving a slight slope downwards from the crista iliaca with 50-75% tension. For the posterior fiber; Starting from the trochanter major, 50-75% tension will be applied along the muscle fiber.
Placebo Comparator: placebo group
Tape application will be applied in the placebo group as it was in the experimental group. Kinesiology taping will be attached horizontally without tension along the Tensor Facie Late line. The application to the ankle will be attached horizontally without tension slightly above the lateral malleolus.
Other: exercise

Exercise protocol:

Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching

Other: placebo
In the placebo tape application, the kinesiological tappings will be adhered horizontally without tension along the long line of the Tensor facie late muscle. The application to the ankle will be attached horizontally, without tension, slightly above the lateral malleolus.

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
Calcaneo-tibial angle measurement
Time Frame: 10 weeks
The calcaneo-tibial angle measurement is a method used in the general evaluation of the foot. By measuring this angle, it is checked whether the problems in the foot are related to the rear foot. Normal values in this measurement are eversion angles between 4° and 8°. During the evaluation, the angle between the axis passing through the middle of the calcaneus and the place where the Achilles tendon attaches to the calcaneus will be measured, while the patient is in the prone position, not putting weight on his foot. Measurements will be made again while standing on the ground. Each measurement will be repeated 3 times. The differences between the results obtained during standing and prone lying will be calculated. The measurements will be averaged and recorded.
10 weeks
Navicular bone drop test
Time Frame: 10 weeks
This assessment method evaluates midfoot mobility and medial longitudinal arch depression. In this method, the measurements should be between 5-9 mm. Before the evaluation, the height of the tubercle of the navicular bone will be measured in meters in millimeters, while the patient is in a sitting position, not putting weight on his feet. Then, the patient will be lifted up, and the patient will be asked to give equal weight to both feet in an upright position, and the measurement will be repeated 3 times. The average of the measurements will be recorded after they are taken. After the measurement, the difference between standing and in bed will be found.
10 weeks

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.
Uskudar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Burhan SANCAKDAR, Uskudar 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.
September 1, 2023

Primary Completion (Actual)

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.
November 1, 2023

Study Completion (Actual)

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.
November 12, 2023

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).
August 9, 2023

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.
August 16, 2023

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.
August 22, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
November 14, 2023

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.
November 13, 2023

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.
November 1, 2023

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.
  • Uskudar68

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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