Effect of Elastic Bandage on Balance in Chronic Ankle Instability
Primary Purpose
Ankle Sprain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Elastic Bandage (Idealplast C®)
Pretape cramer® (non standarized tape)
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprain focused on measuring Adhesive elastic bandaging, balance, posturography
Eligibility Criteria
Inclusion Criteria:
Subjects with Chronic Ankle Instability
Exclusion Criteria:
Neurologic disease Vestibular disease
Sites / Locations
- Francisco Molina Rueda. Avda. de Atenas. s/n.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
elastic bandage
Non-standardized tape (NST)
Arm Description
In this study, Idealplast C® (6cm*2.5m) was used.
In the NST group, Pretape Cramer® (100% cotton, 1.25cm*10m) was used.
Outcomes
Primary Outcome Measures
Balance using a computerized dynamic posturography test: the sensory organization test
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02682303
First Posted
January 28, 2016
Last Updated
October 17, 2016
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02682303
Brief Title
Effect of Elastic Bandage on Balance in Chronic Ankle Instability
Official Title
Effect of Elastic Bandage on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Adhesive elastic bandaging, balance, posturography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
elastic bandage
Arm Type
Experimental
Arm Description
In this study, Idealplast C® (6cm*2.5m) was used.
Arm Title
Non-standardized tape (NST)
Arm Type
Placebo Comparator
Arm Description
In the NST group, Pretape Cramer® (100% cotton, 1.25cm*10m) was used.
Intervention Type
Device
Intervention Name(s)
Elastic Bandage (Idealplast C®)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Pretape cramer® (non standarized tape)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Balance using a computerized dynamic posturography test: the sensory organization test
Description
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.
Time Frame
7 days
10. Eligibility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with Chronic Ankle Instability
Exclusion Criteria:
Neurologic disease Vestibular disease
Facility Information:
Facility Name
Francisco Molina Rueda. Avda. de Atenas. s/n.
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.urjc.es
Description
University
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Effect of Elastic Bandage on Balance in Chronic Ankle Instability
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