NCT02266290

Brief Summary

The Objective is to examine the immediate and prolonged effects (seven days) of Kinesio® Tape (KT) on balance in subjects with chronic ankle instability using Computerized dynamic posturography (CDP). Design. A 7 days follow-up, single-blind randomized controlled trial. Setting. University community. Participants. A sample of 30 subjects aged 18 to 28 with CAI and subjective perception of ankle instability (FAI) was enrolled in this study. Interventions. Participants will be randomly divided into two groups: an experimental group in which was applied KT, and a control group in which was applied a placebo tape.Objective. To examine the immediate and prolonged effects (seven days) of Kinesio® Tape (KT) on balance in subjects with chronic ankle instability using Computerized dynamic posturography (CDP). Design. A 7 days follow-up, single-blind randomized controlled trial. Setting. University community. Participants. A sample of 30 subjects aged 18 to 28 with CAI and subjective perception of ankle instability (FAI) was enrolled in this study. Interventions. Participants were randomly divided into two groups: an experimental group in which was applied KT, and a control group in which was applied a placebo tape. Main Outcome Measure(s). The CDP device employed in this study was Smart Equitest® version 8.2. CDP analysis was conducted using the Sensory organization test (SOT). The composite SOT score (COMP) and the composite SOT strategy (STR), the partial score for SOT condition 2 (SOT 2) and its strategy (STR 2) were considered as outcomes measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

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

Study Start

First participant enrolled

January 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
Last Updated

October 17, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

October 10, 2014

Last Update Submit

October 16, 2014

Conditions

Keywords

ADHESIVE TAPEANKLE INJURYPOSTURAL BALANCEFUNCTIONAL ANKLE INSTABILITY

Outcome Measures

Primary Outcomes (1)

  • Computerized dynamic posturography

    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)

Kinesio-Tape group

EXPERIMENTAL

In this study, Sport tex® kinesiotape over lateral ankle (6cm\*2.5m) is used.

Procedure: taping of ankle sprainDevice: Sport tex® kinesiotape

Placebo Tape Group

PLACEBO COMPARATOR

In the placebo group, Pretape Cramer® (100% cotton, 1.25cm\*10m) was used. With patient in the same position described above, horizontal strips were placed covering the sural region with no defined direction.

Procedure: taping of ankle sprainDevice: Pretape Cramer®

Interventions

All participants were taped for a lateral ankle sprain. 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.

Kinesio-Tape groupPlacebo Tape Group
Kinesio-Tape group
Placebo Tape Group

Eligibility Criteria

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

You may qualify if:

  • history of at least 1 acute lateral ankle sprain that resulted in swelling, pain, and temporary loss of function (but none in the previous 3 months).
  • history of multiple episodes of the ankle ''giving-way'' in the past 6 months-
  • a score below 27 in the Cumberland Ankle Instability Tool.
  • evidence of mechanical instability assessed by a physician using an anterior drawer test

You may not qualify if:

  • history of lower limb injury other than the unilateral Chronic ankle instability and skin allergy to the tape.
  • To be actively involved in any kind of physical activity or rehabilitation program.

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 Publications (1)

  • de-la-Torre-Domingo C, Alguacil-Diego IM, Molina-Rueda F, Lopez-Roman A, Fernandez-Carnero J. Effect of Kinesiology Tape on Measurements of Balance in Subjects With Chronic Ankle Instability: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Dec;96(12):2169-75. doi: 10.1016/j.apmr.2015.06.022. Epub 2015 Sep 7.

Related Links

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Isabel Mª Alguacil-DIego, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

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

October 10, 2014

First Posted

October 17, 2014

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

October 17, 2014

Record last verified: 2014-10

Locations