Immediate and Delayed Effects of Kinesio Taping on the Neuromuscular Performance (IDEKTNP)

April 24, 2017 updated by: Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte

Immediate and Delayed Effects of Kinesio Taping on the Neuromuscular Performance, Balance and Lower Limb Function of Healthy Subjects: Randomized Clinical Trial

The purpose of this study is analyze the immediate and late effects of the application of KT in neuromuscular performance of the quadriceps in postural balance and function of the lower limb of healthy subjects.

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

Sixty volunteers, females will be recruited and randomly divided into 3 groups with 20 members each: control group (CG) - 10 minutes at rest; placebo group (PG) - Kinesio Taping (KT) without application of tension in the vastus lateralis (VL), vastus (VM) and rectus femoris (RF); and Kinesio Taping group (KTG) - application of KT with tension in VL, VM and RF. All volunteers will be evaluated for their distance from the single and triple hop test, postural balance (baropodometry), the joint position sense (JPS), the knee extensor torque (concentric and eccentric assessment at 60 °/s) and electromyographic activity of the VL muscle in five distinct stages: the first before the intervention (AV1), the second immediately after (AV2) and the following three 24h (AV3), 48 (AV4) after the intervention protocol. Soon after the AV4, KT will be removed after 24 hours and take place the last review (AV5).

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.
60

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

  • Brazil
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59078-970
        • Universidade Federal do Rio Grande do Norte

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 28 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Be recreationally active, with no history of osteomyoarticular lesion or surgery in the lower limbs in the previous six months, non-corrected neurological, vestibular, visual and/or hearing impairments, in addition to displaying no allergy to adhesive material.

Exclusion Criteria:

  • Individuals experiencing pain during collection procedures or who do not perform exercises as instructed by the researchers would be excluded.

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: Prevention
  • 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.
No Intervention: Control group
The control group remains at rest for 10 minutes, which is not applied KT in the RF, VL and VM muscles. The volunteers of this group perform all evaluation without the application of KT
Placebo Comparator: Placebo group
The Kinesio Taping (KT) is applied on the vastus lateralis (VL), vastus medialis (VM) and rectus femoris (RF) muscles longitudinally from proximal to the distal. For the RF proximal anchor is applied 5cm below the anterior superior iliac spine and the distal anchor the upper edge of the patella. VL in the proximal and distal anchor will be fixed in greater trochanter of the femur and the lateral edge of the patella. As for the VM muscle proximal anchor will be applied to the middle third from the medial region of the thigh and the distal anchor on the medial edge of the patella. The anchors are applied with 0% tension and therapy area will follow on the belly of the muscles with a 0%.
Other: placebo Functional elastic tape
application of KT without tension in the vastos medialis, rectus femoris and vastus lateralis muscles
Other Names:
  • placebo Kinesio Taping
Experimental: Kinesio Taping group
The Kinesio Taping (KT) is applied on the vastus lateralis (VL), vastus medialis (VM) and rectus femoris (RF) muscles longitudinally from proximal to the distal. For the RF proximal anchor is applied 5cm below the anterior superior iliac spine and the distal anchor the upper edge of the patella. VL in the proximal and distal anchor will be fixed in greater trochanter of the femur and the lateral edge of the patella. As for the VM muscle proximal anchor will be applied to the middle third from the medial region of the thigh and the distal anchor on the medial edge of the patella. The anchors are applied with 0% tension and therapy area will follow on the belly of the muscles with a 50%. This application will be held with subjects standing on one foot, with the hip of the non-dominant limb at 0º and knee flexed at 90º.
Other: Functional elastic tape
application of KT with tension in the vastos medialis, rectus femoris and vastus lateralis muscles
Other Names:
  • Kinesio Taping

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
Muscle Performance measured through isokinetic dynamometry
Time Frame: baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.
Change from baseline in muscle performance at 72 hours.Immediate and Delayed Effects of Kinesio Taping in the muscle performance will be measured through isokinetic dynamometry and the variables analyzed will be peak torque normalized for body weight, mean power, total work and time to peak torque.
baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.

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
Balance measured through baropodometry
Time Frame: baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.
Change from baseline in balance at 72 hours. Immediate and Delayed Effects of Kinesio Taping in balance will be Measured by baropodometry
baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.
Lower limb function
Time Frame: baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.
Change from baseline in lower limb function at 72 hours. Immediate and Delayed Effects of Kinesio Taping will be measure through distance of the single and triple hop test.
baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.
Proprioception measured through joint position sense in the isokinetic dynamometer
Time Frame: baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.
Change from baseline in proprioception at 72 hours. Immediate and Delayed Effects of Kinesio Taping in the proprioception will be measured through joint position sense
baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.
Muscle activation measured through surface electromyography
Time Frame: baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.
Change from baseline in muscle activation at 72 hours. Immediate and Delayed Effects of Kinesio Taping in Muscle activation will be Measured by surface electromyography
baseline, one minute after the intervention protocol, 24 hours, 48 hours and 72 hours after the intervention protocol.

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.
Universidade Federal do Rio Grande do Norte

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.
  • Principal Investigator: Jamilson S Brasileiro, PhD, Universidade Federal do Rio Grande do Norte

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.
June 1, 2015

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.
December 1, 2015

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.
December 1, 2015

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).
April 9, 2015

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.
April 27, 2015

First Posted (Estimate)

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.
May 1, 2015

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 25, 2017

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 24, 2017

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, 2017

More Information

Terms related to this study

Keywords

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.
  • 752.302

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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