An Analysis of Kinesio® Tape on Mitigation of Dynamic Knee Valgus

June 2, 2021 updated by: North Dakota State University

Participants will completed a 5 minute warm-up on a stationary bike. Next, participants will perform 3 practice trials of the double leg jump landing (DJL) test off of a 30 cm box. In order for the trial to count the participants need to maintain their landing posture for at least 2 seconds, if they are unable to do so the trial will be repeated.

After the completion of three practice trials of the DJL test, the first taping condition will be applied. Each participant will receive 3 taping conditions to the dominant leg, a gluteus medius facilitation (GM), a spiral technique (ST), and no tape (NT). The order of conditions will be randomized.

The use of a no tape condition will act a control for both the jumping protocol and the Y-balance test. For this condition, no tape or intervention of any kind will be applied to the subject before completing either tasks. Regardless of the order of randomly assigned taping condition, the participant will rest 10 minutes in a non-weight bearing position before completing a round of testing.

During the 10-minute rest, 3D motion analysis sensors will be placed on the participant to assess hip internal rotation and knee valgus in the frontal plane. After the sensors are applied, the first follow-up Y Balance Test will be completed.

Each participant will complete the Y Balance Test 3 times, once for each condition. For the trial to count, the reach foot is not permitted to touch the floor and the hands have to remain stationary on the pelvis. If the participant fails to meet the testing criteria, the trial will be repeated. At the end of the trial, each testing direction distance will be written down and a mean score will be calculated.

Following the first Y balance test, three DJL tests will be performed, each separated by a 60-second rest period. Once the participant completes 3 approved trials, the first taping condition will be removed and the procedure will be repeated for the second and third taping procedures.

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

The facilitative gluteus medius application was applied from origin to insertion of the muscle, as specified by Dr. Kase (2013). The subject was positioned in side-lying with the dominant leg facing up. The CKTP cut a Y-strip of Kinesio® Tex Classic Tape the same distance from the participant's ASIS to the greater trochanter of the femur. The tape was anchored at the ASIS with no tension followed by the participant moving into approximately 90° hip flexion, adduction, and internal rotation. Then, each tail of the Y-strip was applied at 25% tension towards the greater trochanter where it was anchored again with no tension. Following application, the participant was instructed to remain in a position of comfort for 10 minutes before continuing with the study protocol.

The second taping condition utilized is a spiral technique (ST), applied with Kinesio® Tex Performance Plus Tape. Participant positioning included standing in an open-packed, double-leg stance with feet approximately hip width apart. The CKTP anchored an I-strip of tape with no tension on the participant's medial aspect of the middle, tibia. With a stabilizing hand on the anchor, the practitioner pulled the tape with 75-100% tension and applied towards the lateral aspect of the tibiofemoral joint, Once the tape moved to the posterior side of the knee, the CKTP reduced the tension to 0% over the popliteal fossa so as to reduce skin tearing and provide another mechanism for pulling the knee out of valgum. When the tape crossed diagonally over the popliteal fossa, the CKTP again employed at 75-100% tension from the medial femoral condyle to the vastus lateralis. The tape was then secured to the posterior thigh with an anchor at 0% tension. Thus, the tape created a spiral shape up the participants' leg. Again, the subject was directed to rest comfortably in a non-weight bearing position for 10 minutes.

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.
30

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

  • United States
    • North Dakota
      • Fargo, North Dakota, United States, 58108
        • North Dakota State University

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • current participation in basketball or volleyball

Exclusion Criteria:

  • present pain with jumping or landing
  • history of lower limb surgery within the12 months of the study
  • any contraindications to Kinesio® Tape

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: Factorial 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.
No Intervention: Control
Experimental: Hip
Other: Kinesio Tape
Gluteus medius facilitation and knee spiral taping techniques will be applied to treat dynamic knee valgus
Experimental: Knee
Other: Kinesio Tape
Gluteus medius facilitation and knee spiral taping techniques will be applied to treat dynamic knee valgus

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
Three dimensional motion analysis
Time Frame: 1 day
Assessment of knee valgus in the frontal plane
1 day
Y-balance test
Time Frame: 1 day
Functional screening tool, which can be used to assess lower extremity stability, monitor rehabilitation progress, to understand deficits after injury, and identify athletes at high risk for lower extremity injury
1 day
Drop jump landing test
Time Frame: 1 day
Clinical test with a high reliability of 95% to screen for lower limb injury, including a high specificity (46.07%) and sensitivity (95.04%) to predict ACL injury
1 day

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.
North Dakota State University

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 26, 2021

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.
April 5, 2021

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.
April 5, 2021

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).
February 8, 2021

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.
February 22, 2021

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.
February 24, 2021

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.
June 7, 2021

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.
June 2, 2021

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.
June 1, 2021

More Information

Terms related to this study

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.
  • IRB0003317

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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