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CompletedNCT02682303Updated Oct 18, 2016

Effect of Elastic Bandage on Balance in Chronic Ankle Instability

An interventional study of Elastic Bandage (Idealplast C®) and Pretape cramer® (non standarized tape) in Ankle Sprain, sponsored by Universidad Rey Juan Carlos. Completed at 1 site in Spain. Open to participants aged 18 Years to 28 Years. Per ClinicalTrials.gov, last updated 2016-10-18.

Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 28 Years
01

Study 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.

02

Conditions studied

  • Ankle Sprain

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Keywords

  • Adhesive elastic bandaging
  • balance
  • posturography
03

In context

Ankle Injuries

351 studies on the registry are indexed under Ankle Injuries; 71 are open to participants now.

This study's enrollment of 28 is below the median of 56 across 273 interventional studies indexed under Ankle Injuries.

Browse Ankle Injuries studies →

Lead sponsor

Universidad Rey Juan Carlos is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 28 Years
Accepts healthy volunteers
No

Inclusion criteria

Subjects with Chronic Ankle Instability

Exclusion criteria

Exclusion Criteria:

Neurologic disease Vestibular disease

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    elastic bandage

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

    Device: Elastic Bandage (Idealplast C®)

  • 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)

Interventions

  • DeviceElastic 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

  • DevicePretape 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.

06

What researchers measure

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.

    Time frame: 7 days

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Study locations

1 site
  • Francisco Molina Rueda. Avda. de Atenas. s/n.
    Alcorcón, Madrid 28922, Spain
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02682303
Lead sponsor
Universidad Rey Juan Carlos
Responsible party
Josue Fernandez Carnero (PhD, Universidad Rey Juan Carlos) — Principal investigator
First posted
Feb 15, 2016
Start date
Mar 2016
Primary completion
May 2016
Completion
Aug 2016
Last update
Oct 18, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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