NCT03173911

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

May 29, 2017

Last Update Submit

May 31, 2017

Conditions

Keywords

BalancePostural controlElastic BandagesForce plate

Outcome Measures

Primary Outcomes (1)

  • Changes in center of Pressure Area (COP)

    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 Outcomes (4)

  • Mean velocity in anteroposterior direction (VAP)

    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)

    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)

    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)

    Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage

Study Arms (4)

Ankle

ACTIVE COMPARATOR

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

Hamstrings

ACTIVE COMPARATOR

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

Lumbar

ACTIVE COMPARATOR

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

Total

ACTIVE COMPARATOR

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

Interventions

BandageDEVICE

Application of Elastic Bandage Therapy by the Therapy Taping method

Also known as: Therapy Taping, Elastic Tape, Elastic bandage, Therapeutic elastic bandage
AnkleHamstringsLumbarTotal

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

BandagesCompression Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized clinical trial where participants will be allocated into four intervention groups: G1 (n = 12) will receive therapeutic elastic bandage by the Therapy Taping® method (BET) in the ankles; G2 (n = 12) will receive the application of the BET in the lumbar region and G4 (n = 12) will receive the application for all the strategies. The individuals' balance will be evaluated in four moments: pre-intervention (Pre), immediately (Ime), 24 and 48 hours after intervention (24h and 48h). The main equilibrium parameters analyzed will be: ellipse area (95%) of COP in square centimeters (A-COP in cm2), average speed in centimeters per second (VM in cm / s) and average frequency in Hertz (FM in Hz) Of COP oscillations in the anterior-posterior (A / P) and mid-lateral (M / L) directions, during three postural control tasks: open-eye semitandem (STOA) and right and left unipodal support (UNPD And UNPE).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 2, 2017

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

June 2, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share