Effects of the Elastic Bandage on the Postural Balance of Young Women

May 31, 2017 updated by: Helen Christofel, Universidade Norte do Paraná
Elastic Bandaging Therapy (BET) is a technique that consists of the application of elastic adhesive tape directed on a skin, and is used for pain reduction, improvement of flexibility, postural alignment. It is believed that it can help proprioception by increasing or reducing muscle tension by acting on motor coordination and balance. The present study aims to evaluate the effect of the application of different BET strategies on the postural balance of healthy young women through measures obtained through a proper instrument for a balance assessment, a force platform.

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.

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.
48

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

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women aged between 18 and 35 years;
  • not present chronic pain defined as daily or almost daily pain during the last three months;
  • not participate in rehabilitation programs.

Exclusion Criteria:

  • present any type of neurological, cardiorespiratory, metabolic and / or orthopedic disease of high severity;
  • vestibulopathies and labyrinthine crises;
  • mental problems, attention and speech disorders;
  • some other type of impediment or problem that interfered with physical and functional tests;
  • Have undergone some kind of locomotor surgery;
  • pregnancy;
  • no participation in the three days of the research;
  • lack of understanding or non-cooperation regarding research procedures and methods;
  • do not volunteer.

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • 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: Ankle
composed by 12 participants who will receive the application of the bandage for the ankle strategy in both lower limbs, being determined the application of the technique in I without fixed point, from medial malleolus to lateral malleolus passing under the hindfoot, finally a cleavage technique passing over the malleoli and ending in the anterior region of the ankle joint. The balance of each individual will be evaluated in the force platform at four different times, before, immediately after, after 24 and 48 hours after the application of the bandage, in three different tasks of postural control in the force platform, being: unipedal right, unipedal left and task Of bipedal support in the semi-tandem position. Will be performed three evaluations of 30s each, with 30s of interval between each evaluation.
Device: Bandage
Application of Elastic Bandage Therapy by the Therapy Taping method
Other Names:
  • Therapy Taping
  • Elastic Tape
  • Elastic bandage
  • Therapeutic elastic bandage
ACTIVE_COMPARATOR: Hamstrings
composed by 12 participants who will receive the application of the bandage for the posterior thigh (hamstrings) strategy in both lower limbs. The technique will be determined in I with fixed point of the skin of the ischial tuberosity and moving point until the Lateral tibia (near the head of the fibula) and medial tibia (goose-foot insertion). The balance of each individual will be evaluated in the force platform at four different times, before, immediately after, after 24 and 48 hours after the application of the bandage, in three different tasks of postural control in the force platform, being: unipedal right, unipedal left and task Of bipedal support in the semi-tandem position. Will be performed three evaluations of 30s each, with 30s of interval between each evaluation.
Device: Bandage
Application of Elastic Bandage Therapy by the Therapy Taping method
Other Names:
  • Therapy Taping
  • Elastic Tape
  • Elastic bandage
  • Therapeutic elastic bandage
ACTIVE_COMPARATOR: Lumbar
composed by 12 participants who will receive the application of the bandage for the hip (lumbar) strategy, being determined the application of the technique in I with fixed point in the ischial tuberosity and moving point until the height of the last ribs, making a cleavage in the Height of the superior iliac spine. The balance of each individual will be evaluated in the force platform at four different times, before, immediately after, after 24 and 48 hours after the application of the bandage, in three different tasks of postural control in the force platform, being: unipedal right, unipedal left and task Of bipedal support in the semi-tandem position. Will be performed three evaluations of 30s each, with 30s of interval between each evaluation.
Device: Bandage
Application of Elastic Bandage Therapy by the Therapy Taping method
Other Names:
  • Therapy Taping
  • Elastic Tape
  • Elastic bandage
  • Therapeutic elastic bandage
ACTIVE_COMPARATOR: Total
composed by 12 participants who will receive the application of the bandage for all strategies in both lower limbs, being determined the application of the technique in I with fixed point in the II and III toes and moving point until the height of the last ribs , Passing through the entire posterior region. The balance of each individual will be evaluated in the force platform at four different times, before, immediately after, after 24 and 48 hours after the application of the bandage, in three different tasks of postural control in the force platform, being: unipedal right, unipedal left and task Of bipedal support in the semi-tandem position. Will be performed three evaluations of 30s each, with 30s of interval between each evaluation.
Device: Bandage
Application of Elastic Bandage Therapy by the Therapy Taping method
Other Names:
  • Therapy Taping
  • Elastic Tape
  • Elastic bandage
  • Therapeutic elastic bandage

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
Changes in center of Pressure Area (COP)
Time Frame: Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage
Ellipse area (95%) of the center of pressure (COP) in cm2
Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage

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
Mean velocity in anteroposterior direction (VAP)
Time Frame: Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage
Mean velocity (cm/s) of COP oscillation in the anteroposterior direction of movement
Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage
Mean velocity in the mid-lateral direction (VML)
Time Frame: Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage
Mean velocity (cm/s) of COP oscillation in the mid-lateral direction of movement
Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage
Mean frequency in anteroposterior direction (FAP)
Time Frame: Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage
Mean frequency (in Hz) of COP oscillation in the anteroposterior direction of movement
Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage
Mean frequency in the mid-lateral direction (FML)
Time Frame: Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage
Mean frequency (in Hz) of COP oscillation in the mid-lateral direction of movement
Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage

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 Norte do Paraná

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.
May 1, 2016

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.
February 1, 2017

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.
February 1, 2017

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).
May 29, 2017

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.
May 31, 2017

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.
June 2, 2017

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 2, 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.
May 31, 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.
May 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.
  • Projeto Kinesio

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

Yes

product manufactured in and exported from the U.S.

Yes

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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