- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266290
Effect of Kinesio® Taping in Chronic Ankle Instability
Effect of Kinesio® Taping on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid
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Alcorcón, Madrid, Spain, 28922
- Francisco Molina Rueda. Avda. de Atenas. s/n.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinesio-Tape group
In this study, Sport tex® kinesiotape over lateral ankle (6cm*2.5m) is used.
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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.
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Placebo Comparator: Placebo Tape Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Computerized dynamic posturography
Time Frame: 7 days
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isabel Mª Alguacil-DIego, PhD, Universidad Rey Juan Carlos
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URJC_21_2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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