Ankle SprainNCT02266290
Effect of Kinesio® Taping in Chronic Ankle Instability
A study testing taping of ankle sprain, Sport tex® kinesiotape and Pretape Cramer® in people with Ankle Sprain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- taping of ankle sprain, Sport tex® kinesiotape and Pretape Cramer®
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Francisco Molina Rueda. Avda. de Atenas. s/n.
Alcorcón, Madrid, 28922
About this study
Official title: Effect of Kinesio® Taping on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Ankle Sprain
- Being tested
- taping of ankle sprain, Sport tex® kinesiotape, Pretape Cramer®
- Keywords
- ADHESIVE TAPE, ANKLE INJURY, POSTURAL BALANCE, FUNCTIONAL ANKLE INSTABILITY
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taping of ankle sprainProcedure or surgery
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.
Sport tex® kinesiotapeDevice
Pretape Cramer®Device
| Study group | Role | What they receive |
|---|---|---|
| Kinesio-Tape group | Experimental | In this study, Sport tex® kinesiotape over lateral ankle (6cm*2.5m) is used. Receives: Procedure: taping of ankle sprain; Device: 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. Receives: Procedure: taping of ankle sprain; Device: Pretape Cramer® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Isabel Mª Alguacil-DIego, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266290
- Sponsor's protocol ID
- URJC_21_2012
- Status last verified
- Oct 2014
- First submitted
- 10 Oct 2014
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26360974
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio® Taping on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02266290
- Acronym / sponsor ID
- URJC_21_2012
- Conditions
- Ankle Sprain
- Keywords
- ADHESIVE TAPE, ANKLE INJURY, POSTURAL BALANCE, FUNCTIONAL ANKLE INSTABILITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio-Tape group | Experimental | Procedure: taping of ankle sprain, Device: Sport tex® kinesiotapeIn this study, Sport tex® kinesiotape over lateral ankle (6cm*2.5m) is used. |
| Placebo Tape Group | Placebo comparator | Procedure: taping of ankle sprain, Device: Pretape Cramer®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. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taping of ankle sprainAll 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. | Procedure or surgery | Kinesio-Tape group, Placebo Tape Group |
| Sport tex® kinesiotape | Device | Kinesio-Tape group |
| Pretape Cramer® | Device | Placebo Tape Group |
Primary outcome
Computerized dynamic posturography
Time frame: 7 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
- Derived from this study: PubMed 26360974de-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.
- UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Mª Alguacil-DIego, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taping of ankle sprain, Sport tex® kinesiotape and Pretape Cramer® in people with Ankle Sprain, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized dynamic posturography (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02266290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.