- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03173911
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
Study Type
Interventional
Enrollment (Actual)
48
Phase
- 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
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 |
Intervention / Treatment |
---|---|
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.
|
Application of Elastic Bandage Therapy by the Therapy Taping method
Other Names:
|
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.
|
Application of Elastic Bandage Therapy by the Therapy Taping method
Other Names:
|
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.
|
Application of Elastic Bandage Therapy by the Therapy Taping method
Other Names:
|
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.
|
Application of Elastic Bandage Therapy by the Therapy Taping method
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
May 1, 2016
Primary Completion (ACTUAL)
February 1, 2017
Study Completion (ACTUAL)
February 1, 2017
Study Registration Dates
First Submitted
May 29, 2017
First Submitted That Met QC Criteria
May 31, 2017
First Posted (ACTUAL)
June 2, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 2, 2017
Last Update Submitted That Met QC Criteria
May 31, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID 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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