NCT02682303

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

January 28, 2016

Last Update Submit

October 17, 2016

Conditions

Keywords

Adhesive elastic bandagingbalanceposturography

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

EXPERIMENTAL

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

Device: Elastic Bandage (Idealplast C®)

Non-standardized tape (NST)

PLACEBO COMPARATOR

In the NST group, Pretape Cramer® (100% cotton, 1.25cm\*10m) was used.

Device: Pretape cramer® (non standarized tape)

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

elastic bandage

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.

Non-standardized tape (NST)

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

Related Links

MeSH Terms

Conditions

Ankle Injuries

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

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

Locations