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Effect of Kinesio® Taping in Chronic Ankle Instability

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
taping of ankle sprain
Sport tex® kinesiotape
Pretape Cramer®
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring ADHESIVE TAPE, ANKLE INJURY, POSTURAL BALANCE, FUNCTIONAL ANKLE INSTABILITY

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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

Kinesio-Tape group

Placebo Tape Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2014
Last Updated
October 16, 2014
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT02266290
Brief Title
Effect of Kinesio® Taping in Chronic Ankle Instability
Official Title
Effect of Kinesio® Taping on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (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
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.
Detailed Description
Participants were randomly distributed (using the QuickCalcs application from GraphPad Software)a into two groups: an experimental group in which was applied KT, and a control group in which was applied a placebo tape. All outcomes in both groups were assessed by an assessor blinded to the subject´s allocation. Individuals were also blinded to the allocation group. Balance was assessed using the SOT under three conditions: (1) without taping; (2) immediately following application; (3) following 7 days of use. Computerized dynamic posturography is used to measure the balance. Subjects had to maintain their COG stable in 3 consecutive series of 20s duration for each of the 6 conditions in the test. In the first 3 conditions, the platform remained fixed. Condition 1 was conducted with open eyes, condition 2 with closed eyes and condition 3 with a mobile visual environment referenced to postural oscillations. Conditions 4, 5 and 6 repeated the visual conditions of the first 3 tests and added platform movement referenced to the anteroposterior oscillation of the subject, with the ankle-foot angle remaining constant, thus annulling proprioceptive sensory input. The system utilizes force-plate technology (two 23 × 46 cm footplates) to determine the location of the COG within predefined 75% limits of stability while adjusting for an individual subject's height (COG = 0.55 × height). For each test, the software provides measures of postural sway and the ability to maintain the COG within a predefined target area resulting in partial scores for each condition and an overall balance score (composite SOT score, COMP) (%). The theoretical maximum displacement a normal subject may sway without fall is assumed to be 12.5 degrees (8.25 degrees anterior, 4.25 degrees posterior). The equilibrium score = 12.5 - Ɵ (maximum - minimum)/12.5 × 100%, where Ɵ is the maximum anteroposterior COG sway angle recorded in each trial. Values close to 100% indicated minimum balancing. Test was scored with a value of 0 when patients needed help or took a step to maintain balance. SOT condition 2 is the best trial in order to assess the influence of KT on proprioceptive system in subjects without vestibular deficits. As primaries outcome measures, the composite SOT score (COMP) and the composite SOT strategy (STR), were chosen. The partial score for SOT condition 2 (SOT 2) and its strategy (STR 2) were considered as secondary outcomes measures. SOT condition 2 is carried out with closed eyes. Therefore, balance under this condition is controlled mainly by the proprioceptive system, in which, according several authors, KT could have an effect. Under these All subjects were initially familiarized with the CDP before undergoing. Multiple baseline measures of the SOT were administrated in order to document change due to tape application and to avoid the learning effect.26 It has been suggested a short-term adaption that reduces the postural sway by either increasing the stiffness in the ankles or through reweighting of sensory information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
ADHESIVE TAPE, ANKLE INJURY, POSTURAL BALANCE, FUNCTIONAL ANKLE INSTABILITY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio-Tape group
Arm Type
Experimental
Arm Description
In this study, Sport tex® kinesiotape over lateral ankle (6cm*2.5m) is used.
Arm Title
Placebo Tape Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
taping of ankle sprain
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sport tex® kinesiotape
Intervention Type
Device
Intervention Name(s)
Pretape Cramer®
Primary Outcome Measure Information:
Title
Computerized dynamic posturography
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

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Mª Alguacil-DIego, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
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

Citations:
PubMed Identifier
26360974
Citation
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.
Results Reference
derived
Links:
URL
http://www.urjc.es
Description
University

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Effect of Kinesio® Taping in Chronic Ankle Instability

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