Effect of Elastic Bandage on Balance in Chronic Ankle Instability
Effect of Elastic Bandage on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 15, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 18, 2016
October 1, 2016
2 months
January 28, 2016
October 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
7 days
Study Arms (2)
elastic bandage
EXPERIMENTALIn this study, Idealplast C® (6cm\*2.5m) was used.
Non-standardized tape (NST)
PLACEBO COMPARATORIn the NST group, Pretape Cramer® (100% cotton, 1.25cm\*10m) was used.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Subjects with Chronic Ankle Instability
You may not qualify if:
- Neurologic disease Vestibular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Francisco Molina Rueda. Avda. de Atenas. s/n.
Alcorcón, Madrid, 28922, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
January 28, 2016
First Posted
February 15, 2016
Study Start
March 1, 2016
Primary Completion
May 1, 2016
Study Completion
August 1, 2016
Last Updated
October 18, 2016
Record last verified: 2016-10