Effect of Elastic Bandage on Balance in Chronic Ankle Instability

Sponsor
Universidad Rey Juan Carlos (Other)
Overall Status
Completed
CT.gov ID
NCT02682303
Collaborator
(none)
28
1
2
5
5.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Elastic Bandage (Idealplast C®)
  • Device: Pretape cramer® (non standarized tape)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Elastic Bandage on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: elastic bandage

In this study, Idealplast C® (6cm*2.5m) was used.

Device: Elastic Bandage (Idealplast C®)
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.

Device: Pretape cramer® (non standarized tape)
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.

Outcome Measures

Primary Outcome Measures

  1. Balance using a computerized dynamic posturography test: the sensory organization test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 28 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Subjects with Chronic Ankle Instability

Exclusion Criteria:

Neurologic disease Vestibular disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Francisco Molina Rueda. Avda. de Atenas. s/n. Alcorcón Madrid Spain 28922

Sponsors and Collaborators

  • Universidad Rey Juan Carlos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Josue Fernandez Carnero, PhD, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier:
NCT02682303
Other Study ID Numbers:
  • 05/14
First Posted:
Feb 15, 2016
Last Update Posted:
Oct 18, 2016
Last Verified:
Oct 1, 2016
Keywords provided by Josue Fernandez Carnero, PhD, Universidad Rey Juan Carlos
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2016