Postural ControlNCT03173911
Effects of the Elastic Bandage on the Postural Balance of Young Women
A study testing Bandage in people with Postural Control, run by Universidade Norte do Paraná.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postural Control
- What is being tested?
- Bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- no participation in the three days of the research;
- lack of understanding or non-cooperation regarding research procedures and methods;
- do not volunteer.
About this study
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.
- Conditions
- Postural Control
- Being tested
- Bandage
- Keywords
- Balance, Postural control, Elastic Bandages, Force plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BandageDevice
Also called Therapy Taping, Elastic Tape, Elastic bandage, Therapeutic elastic bandage
Application of Elastic Bandage Therapy by the Therapy Taping method
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in center of Pressure Area (COP)
Ellipse area (95%) of the center of pressure (COP) in cm2
Measured: 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)
Mean velocity (cm/s) of COP oscillation in the anteroposterior direction of movement
Measured: 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)
Mean velocity (cm/s) of COP oscillation in the mid-lateral direction of movement
Measured: 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)
Mean frequency (in Hz) of COP oscillation in the anteroposterior direction of movement
Measured: 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)
Mean frequency (in Hz) of COP oscillation in the mid-lateral direction of movement
Measured: Before the application of the bandage (Pre-intervention), immediately after, twenty-four hours after and forty-eight hours after the application of the bandage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start1 May 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Christofel, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173911
- Sponsor's protocol ID
- Projeto Kinesio
- Status last verified
- May 2017
- First submitted
- 29 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Elastic Bandage on the Postural Balance of Young Women
- ClinicalTrials.gov ID
- NCT03173911
- Acronym / sponsor ID
- Projeto Kinesio
- Conditions
- Postural Control
- Keywords
- Balance, Postural control, Elastic Bandages, Force plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Ankle | Active comparator | Device: Bandagecomposed 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. |
| Hamstrings | Active comparator | Device: Bandagecomposed 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. |
| Lumbar | Active comparator | Device: Bandagecomposed 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. |
| Total | Active comparator | Device: Bandagecomposed 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BandageAlso: Therapy Taping, Elastic Tape, Elastic bandage, Therapeutic elastic bandageApplication of Elastic Bandage Therapy by the Therapy Taping method | Device | Ankle, Hamstrings, Lumbar, Total |
Primary outcome
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
4 secondary outcomes
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 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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bandage in people with Postural Control, run by Universidade Norte do Paraná.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.