Effect of Elastic Bandage on Balance in Chronic Ankle Instability

October 17, 2016 updated by: Josue Fernandez Carnero, Universidad Rey Juan Carlos

Effect of Elastic Bandage on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial

Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on balance control in subjects with chronic ankle instability.

Material and methods: Twenty-eight individuals successfully completed the study protocol, of whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women) and 14 were assigned to the non-standardized tape group ( 9 men, 5 women). To objectively measure postural sway we used computerized dynamic posturography with Sensory Organization Test and Unilateral Stance test. We analyzed the following Sensory Organization Test parameters: the composite Sensory Organization Test score, the composite Sensory Organization Test strategy and the Sensory Organization Test condition 2 and its strategy. In addition, we studied the centre of gravity sway velocity with open eyes and close eyes during the US test.

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • 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

    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Francisco Molina Rueda. Avda. de Atenas. s/n.

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 28 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects with Chronic Ankle Instability

Exclusion Criteria:

Neurologic disease Vestibular disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: elastic bandage
In this study, Idealplast C® (6cm*2.5m) was used.

Elastic bandage

One anchor strip is applied around the ankle with no tension applied to the tape to avoid restricting blood flow. A supporting stirrup strap is applied from the inside of the ankle, under the heel with no tension up to this point. As the tape is passed up the outside of the ankle tension is applied to the tape with the foot in slight dorsiflexion and secured to the anchor strap (black arrow).

For heel lock, a second strip is applied on the outside of the ankle, taken across the front of the ankle and just above the bony part on the inside of the ankle and back towards the heel (red arrow). Then taken around and under the heel back the way you have just come and around the front of the ankle (orange arrow). The tape then passes above the bony part of the ankle on the outside and diagonally towards the heel, across to the inside of the ankle then around the top to finish

Placebo Comparator: Non-standardized tape (NST)
In the NST group, Pretape Cramer® (100% cotton, 1.25cm*10m) was used.

Pretape cramer® was used.

The individual is in supine position keeping the foot and ankle in a neutral position.

The strip (I) is applied with not stretch in the outside of the leg just above the ankle, and then the rest of the strip is applied on the outside of the ankle and under the heel.

This is the only intervention carried out in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance using a computerized dynamic posturography test: the sensory organization test
Time Frame: 7 days

The CDP device employed in this study was Smart Equitest® version 8.2 (NeuroCom International Inc., Clackamas, OR, USA). Posturography analysis was conducted using the SOT. This test assesses postural control through the use of external stimuli on the visual and proprioceptive system.

Participants were instructed to stand on the force-plate facing the visual surround. A safety harness was fixed to prevent injury from falls. Their bare feet position on force-plates was adjusted according to the height of the patient, as marked on the equipment. Subjects had to maintain their COG stable in 3 consecutive series of 20s duration for each of the 6 conditions in the test.

7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

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Helpful Links

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

March 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/14

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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