Sprain and Strain of AnkleNCT02115217
Effect of Kinesiotaping on Ankle Stability
A study testing Leukotape K in people with Sprain and Strain of Ankle, run by Clinique Romande de Readaptation at 1 site in Switzerland.
Trial summary
Ankles sprains are the most popular injuries in basketball players. They are traumatic injuries, which happen most of the time in specific situations, like landing on another player's foot, or during changes of direction. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sprain and Strain of Ankle
- What is being tested?
- Leukotape K
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Jun 2015
- 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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- active elite basketball players
Who cannot join
- no history of ankle sprain in the last 6 weeks
- no history of any other lower limbs lesion in the last 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kinesiotaping on Ankle Stability in a Population of Elite Basketball Players
Ankles sprains are the most popular injuries in basketball players. They are traumatic injuries, which happen most of the time in specific situations, like landing on another player's foot, or during changes of direction.
Neuromuscular exercises are very important to improve ankle stability and reduce risks of sprains. However various external support such as ankles braces and rigid tape, are also used in order to prevent injury.
The kinesiotape (KT) is a new but broadly used method in the world of athletes. Created by KenzoKase, in 1980, this kind of tape has a tremendous success with athletes and is today commonly used during practices and/or competitions. The main property of this tape is its elasticity, which is supposed to improve proprioception and, thus ankle stability, but these aspects have not been investigated yet.
Read the detailed description
Aim: Compare the effects of a kinesiotape (KT) with a sham treatment (KT put with no effects) and a control condition (absence of tape) in basketball players from the Swiss national league through balance tests on an unstable surface.
Hypotheses: A KT positioned on the lateral side of the leg improves ankle stability in basketball players while balancing on an unstable surface.
Method: 30 subjects will be recruited from different basketball teams affiliated to the Swiss national league. They will have to perform some postural stability tests on both unstable ("Delos") and stable surfaces ("Single Les Stance", "Star Excursion Balance Test", "Cross Over Hop Test for Distance") under three different conditions. The three condition will be as followed : with a KT positioned on the lateral side of the leg, with a sham tape or without tape. The three sessions will be spaced in time (7 days of wash out). The order of the three interventions (KT, Sham tape, no tape) will be randomized (cross over) to avoid the bias of learning processes. Neither the subjects nor the examiner will be aware of the "tape condition" (double blind); a physiotherapist will be in charge of positioning the tape according to the tested condition.
The sequence of the tests will be the same for all subjects and breaks are scheduled to avoid the effect of the fatigue. An anamnesis of all subjects will be done in order to evaluate history of injuries. At the end of each session, a visual analogical scale will be completed by the athlete to obtain a personal feeling of stability . The subject will be also asked to determine which condition was tested.
Expected results: the application of a KT on the lateral side of the leg improves postural stability on instable surfaces in elite basketball players.
Field's importance: the application of KT may reduce the risk of ankle sprains and the recurrence of sprains in a population of athletes at risk.
- Conditions
- Sprain and Strain of Ankle
- Being tested
- Leukotape K, Sham kinesiotape
- Keywords
- Kinestiotaping, Basketball players, Effect of kinesiotaping, on postural stability
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukotape KDevice
Also called Leukotape K, Johnson & Johnson
All interventions will be performed by a qualified physiotherapist in a standardized manner. Tape will be extended to the recommended length (120%) and applied along the outer side of the leg, along the path of the peroneal muscle. Starting in the middle of the foot arch, the tape ends 1 cm below tibial head.
Sham kinesiotapeDevice
KT put with no effects
| Study group | Role | What they receive |
|---|---|---|
| Leukotape K, basketball training | Experimental | Use of Leukotape K to ensure stability of the ankle in basketball players Receives: Device: Leukotape K |
| Sham, basketball training | Placebo comparator | Use of sham tape Receives: Device: Sham kinesiotape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of kinesiotaping on postural stability
To assess postural stability, the following parameters will be measured:
Autonomy:
This measure represents the time the subject can stay on the mobile board without the use of his hand to maintain equilibrium.
Mean axis spacing:
This measure will be performed using an accelerometer localized on the sternum of the subjects. This device will allow us to calculate displacement of the chest (degrees of inclination).
Mean error of the board:
This parameter represents numerically the inclination of the board during the test. It allows to estimate the stability of the subjects' ankle (unit=degrees). The larger this value is the lower the stability will be.
An estimation of total equilibrium between each subject will be assessed using the two parameters listed here above (mean axis spacing + mean error of the board) following recommendation of the manufacturer.
Measured: For each subject outcome will be assessed in the 3 weeks following the beginning of the study.
Secondary outcomes (1)
EVA scale to evaluate the sensation of postural stability
Measured: Assessment will be performed within 3 weeks after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sprain and Strain of AnkleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Romande de Readaptation
- Sponsor type
- Research network
- Collaborators
- University of Lausanne
- Responsible party
- Sponsor
- Investigators
- Yan Eggel, MD, Principal investigator, Clinique Romande de ReadaptationLia Volpe, Student, Principal investigator, Institut des Sciences du Sport de l'Université de LausanneOlivier Dériaz, Md, PhD, Study director, Institut de Recherche en ReadaptationJérôme Barral, PhD, Study director, Institut des Sciences du Sport de l'Université de Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115217
- Sponsor's protocol ID
- CliniqueRR-02
- Status last verified
- Jul 2015
- First submitted
- 14 Mar 2014
- Last updated
- 31 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotaping on Ankle Stability in a Population of Elite Basketball Players
- ClinicalTrials.gov ID
- NCT02115217
- Acronym / sponsor ID
- CliniqueRR-02
- Conditions
- Sprain and Strain of Ankle
- Keywords
- Kinestiotaping, Basketball players, Effect of kinesiotaping, on postural stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Clinique Romande de ReadaptationResearch network
- Collaborators
- University of Lausanne
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Apr 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.
Ankles sprains are the most popular injuries in basketball players. They are traumatic injuries, which happen most of the time in specific situations, like landing on another player's foot, or during changes of direction.
Neuromuscular exercises are very important to improve ankle stability and reduce risks of sprains. However various external support such as ankles braces and rigid tape, are also used in order to prevent injury.
The kinesiotape (KT) is a new but broadly used method in the world of athletes. Created by KenzoKase, in 1980, this kind of tape has a tremendous success with athletes and is today commonly used during practices and/or competitions. The main property of this tape is its elasticity, which is supposed to improve proprioception and, thus ankle stability, but these aspects have not been investigated yet.
Detailed description
Aim: Compare the effects of a kinesiotape (KT) with a sham treatment (KT put with no effects) and a control condition (absence of tape) in basketball players from the Swiss national league through balance tests on an unstable surface.
Hypotheses: A KT positioned on the lateral side of the leg improves ankle stability in basketball players while balancing on an unstable surface.
Method: 30 subjects will be recruited from different basketball teams affiliated to the Swiss national league. They will have to perform some postural stability tests on both unstable ("Delos") and stable surfaces ("Single Les Stance", "Star Excursion Balance Test", "Cross Over Hop Test for Distance") under three different conditions. The three condition will be as followed : with a KT positioned on the lateral side of the leg, with a sham tape or without tape. The three sessions will be spaced in time (7 days of wash out). The order of the three interventions (KT, Sham tape, no tape) will be randomized (cross over) to avoid the bias of learning processes. Neither the subjects nor the examiner will be aware of the "tape condition" (double blind); a physiotherapist will be in charge of positioning the tape according to the tested condition.
The sequence of the tests will be the same for all subjects and breaks are scheduled to avoid the effect of the fatigue. An anamnesis of all subjects will be done in order to evaluate history of injuries. At the end of each session, a visual analogical scale will be completed by the athlete to obtain a personal feeling of stability . The subject will be also asked to determine which condition was tested.
Expected results: the application of a KT on the lateral side of the leg improves postural stability on instable surfaces in elite basketball players.
Field's importance: the application of KT may reduce the risk of ankle sprains and the recurrence of sprains in a population of athletes at risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leukotape K, basketball training | Experimental | Device: Leukotape KUse of Leukotape K to ensure stability of the ankle in basketball players |
| Sham, basketball training | Placebo comparator | Device: Sham kinesiotapeUse of sham tape |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- active elite basketball players
Key exclusion criteria (2 listed)
- no history of ankle sprain in the last 6 weeks
- no history of any other lower limbs lesion in the last 6 weeks
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 |
|---|---|---|
| Leukotape KAlso: Leukotape K, Johnson & JohnsonAll interventions will be performed by a qualified physiotherapist in a standardized manner. Tape will be extended to the recommended length (120%) and applied along the outer side of the leg, along the path of the peroneal muscle. Starting in the middle of the foot arch, the tape ends 1 cm below tibial head. | Device | Leukotape K, basketball training |
| Sham kinesiotapeKT put with no effects | Device | Sham, basketball training |
Primary outcome
Effect of kinesiotaping on postural stability
Time frame: For each subject outcome will be assessed in the 3 weeks following the beginning of the study.
To assess postural stability, the following parameters will be measured: Autonomy: This measure represents the time the subject can stay on the mobile board without the use of his hand to maintain equilibrium. Mean axis spacing: This measure will be performed using an accelerometer localized on the sternum of the subjects. This device will allow us to calculate displacement of the chest (degrees of inclination). Mean error of the board: This parameter represents numerically the inclination of the board during the test. It allows to estimate the stability of the subjects' ankle (unit=degrees). The larger this value is the lower the stability will be. An estimation of total equilibrium between each subject will be assessed using the two parameters listed here above (mean axis spacing + mean error of the board) following recommendation of the manufacturer.
1 secondary outcome
EVA scale to evaluate the sensation of postural stability
Time frame: Assessment will be performed within 3 weeks after the beginning of the study
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 31 Jan 2019.
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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.
Yan Eggel, MD principal investigator
Clinique Romande de Readaptation
Lia Volpe, Student principal investigator
Institut des Sciences du Sport de l'Université de Lausanne
Olivier Dériaz, Md, PhD study director
Institut de Recherche en Readaptation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leukotape K in people with Sprain and Strain of Ankle, run by Clinique Romande de Readaptation at 1 site in Switzerland.
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 1 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 31 Jan 2019. 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 Switzerland. 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?
Effect of kinesiotaping on postural stability (time frame: For each subject outcome will be assessed in the 3 weeks following the beginning of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2019.