Kinesio TapingPhase 1/2NCT02057120
Influence of Kinesio Taping on Muscle Activation, Muscle Strength and Performance of Young Football Athletes Jump
A Phase 1/2 study testing Kinesio Taping in people with Kinesio Taping, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The objective of the project is to investigate the influence of application of Kinesio Taping in young athletes in football, muscle strength and muscle activation in the performance of the Single Leg Hop Test tests and Triple Hop Test methods: will be conducted a randomized, placebo-controlled and double-blind. Read more about this study
- Who is it for?
- Ages 15 to 20 years, men only
- Conditions the study is for
- Kinesio Taping
- What is being tested?
- Kinesio Taping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 1/2
- 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 20 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals aged between 15 and 20 years, Football players and Athletes who have body mass index (BMI) considered normal (between 20 and 25).
Who cannot join
- History of lower limb musculoskeletal injuries in the last 6 months, history of lower limb and spine surgery in the last 6 months and BMI over 25 or less than 20.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Nove de Julho
São Paulo, São Paulo, 01415000
Daniela Biasotto Goonzalez, Doctor, +5511999063166, dani_atm@ig.com.br
About this study
Official title: INFLUENCE OF KINESIO TAPING ON MUSCLE ACTIVATION, MUSCLE STRENGTH AND PERFORMANCE JUMP IN YOUNG ATHLETES. CLINICAL STUDY, RANDOMIZED, PLACEBO-CONTROLLED AND DOUBLE BLIND
The objective of the project is to investigate the influence of application of Kinesio Taping in young athletes in football, muscle strength and muscle activation in the performance of the Single Leg Hop Test tests and Triple Hop Test methods: will be conducted a randomized, placebo-controlled and double-blind. 24 individuals will be athletes who fit the criteria for inclusion will be randomized into 2 groups (Placebo, Kinesio Taping Taping) and will be submitted to the tests of Single Leg Hop Test, Triple Hop Test, the isokinetic evaluation and electromyographic of Rectus Femoris dominant lower limb. Then the intervention shall be carried out with application of Kinesio Taping for activation of rectus femoris muscle group and placebo intervention Kinesio Taping with application of Kinesio Taping of transverse way the rectus femoris without tension in the Placebo group Taping. The volunteers will be re-evaluated 30 minutes after application of the technique and 12:0 am after with the same tests for that later can be compared the results obtained in each group. Analysis: will be achieved statistical tests and adopted a significance level of 5 percent
Read the detailed description
The method of bandage with Kinesio Taping created by Kenzo Kase in 1996, it is the application of a thin, elastic tape with a thickness similar to the epidermis, on the skin. Being that it can be stretched up to 140 of its original length making it elastic enough compared to the conventional bandages. Kenzo still claims that the tape is able to reduce pain, swelling, muscle spasms and prevent injury. As much as there is today a widespread use of this technique mainly in the context of sports and orthopedics, still lack reliable studies to support the theory described by this method. Objectives: to investigate the influence of application of Kinesio Taping in young athletes in football, muscle strength and muscle activation in the performance of the Single Leg Hop Test tests and Triple Hop Test methods: will be conducted a randomized, placebo-controlled and double-blind. 24 individuals will be athletes who fit the criteria for inclusion will be randomized into 2 groups (Placebo, Kinesio Taping Taping) and will be submitted to the tests of Single Leg Hop Test, Triple Hop Test, the isokinetic evaluation and electromyographic of Rectus Femoris dominant lower limb. Then the intervention shall be carried out with application of Kinesio Taping for activation of rectus femoris muscle group and placebo intervention Kinesio Taping with application of Kinesio Taping of transverse way the rectus femoris without tension in the Placebo group Taping. The volunteers will be re-evaluated 30 minutes after application of the technique and 12:0 am after with the same tests for that later can be compared the results obtained in each group. Analysis: will be achieved statistical tests and adopted a significance level of 5 percent.
- Conditions
- Kinesio Taping
- Being tested
- Kinesio Taping, Kinesio Taping placebo
- Keywords
- Kinesio Taping, Soccer, Hop Test, Electromyography, Athletic Performance, Muscle Strength Dynamometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingProcedure or surgery
Application of Kinesio (Kinesio Tex Gold ®) of black color. The tape will be applied from proximal to distal, leaving the anterosuperior iliac spine Bottom, passing over the Rectus Femoris and ending in the region of the anterior tibia tuberosity with a voltage of 25 %.
Kinesio Taping placeboDevice
The volunteer who is allocated at random in the placebo group will receive an application of Kinesio transverse way the rectus femoris muscle, in order to verify a possible placebo effect of application of tape.
| Study group | Role | What they receive |
|---|---|---|
| Grupo A (Kinesio Taping) | Active comparator | Will be held the application of Kinesio Taping (Tex Gold) in the region of the rectus femoris dominant lower limb by a physical therapist trained in the technique (KT1 KT2 and) and with experience in this type of application to be designed without knowing in which group fits this patient. In the sequence, the athlete will be oriented to remain at rest for 30 min to get a better grip on the tape and one of the first tests and rest, only after this period will conduct a new evaluation of jump tests (single leg Hop test and Triple Hop Test) and, finally, a new test of strength in the isokinetic dinamomêtro in conjunction with the electromyographic assessment. Receives: Procedure: Kinesio Taping |
| Placebo Taping | Placebo comparator | The volunteer will receive a Placebo application tape, being in this case the physical therapist will apply a strip of Kinesio Taping perpendicular to the muscle fibers of the rectus femoris of the dominant member of the individual. Receives: Device: Kinesio Taping placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hop Test
The volunteer must position themselves in foot with unipodal support in the dominant lower limb behind a line that will be demarcated on the ground and jump as far as possible, without support in the contralateral limb or imbalance. The distance will be measured with a tape measure, from the starting point (line demarcated on the ground) until the most proximal point of the heel of the foot fell on the floor.
Measured: 1 year
Secondary outcomes (1)
Surface electromyography
During isokinetic evaluation will also be carried out a study of the electrical activity of the rectus femoris muscle. For the capture of the electrical signal of that muscle will be used the acquisition system with 8 channels (EMG System of Brazil Ltda ®), composed of active electrodes with bipolar won 20 times amplification, analog filter pass band of 20 to 500 Hz and common mode rejection of 120 dB, and one of the channels will be enabled to use the force transducer (EMG System of Brazil Ltda ®). EMG signals are sampled with 2000 Hz frequency, scanned for AD conversion plate (analog-digital) with 16 bits of resolution.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kinesio TapingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057120
- Sponsor's protocol ID
- 21892213.4.0000.5511
- Status last verified
- Dec 2013
- First submitted
- 4 Feb 2014
- Last updated
- 6 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFLUENCE OF KINESIO TAPING ON MUSCLE ACTIVATION, MUSCLE STRENGTH AND PERFORMANCE JUMP IN YOUNG ATHLETES. CLINICAL STUDY, RANDOMIZED, PLACEBO-CONTROLLED AND DOUBLE BLIND
- ClinicalTrials.gov ID
- NCT02057120
- Acronym / sponsor ID
- 21892213.4.0000.5511
- Conditions
- Kinesio Taping
- Keywords
- Kinesio Taping, Soccer, Hop Test, Electromyography, Athletic Performance, Muscle Strength Dynamometer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 6 Feb 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 of the project is to investigate the influence of application of Kinesio Taping in young athletes in football, muscle strength and muscle activation in the performance of the Single Leg Hop Test tests and Triple Hop Test methods: will be conducted a randomized, placebo-controlled and double-blind. 24 individuals will be athletes who fit the criteria for inclusion will be randomized into 2 groups (Placebo, Kinesio Taping Taping) and will be submitted to the tests of Single Leg Hop Test, Triple Hop Test, the isokinetic evaluation and electromyographic of Rectus Femoris dominant lower limb. Then the intervention shall be carried out with application of Kinesio Taping for activation of rectus femoris muscle group and placebo intervention Kinesio Taping with application of Kinesio Taping of transverse way the rectus femoris without tension in the Placebo group Taping. The volunteers will be re-evaluated 30 minutes after application of the technique and 12:0 am after with the same tests for that later can be compared the results obtained in each group. Analysis: will be achieved statistical tests and adopted a significance level of 5 percent
Detailed description
The method of bandage with Kinesio Taping created by Kenzo Kase in 1996, it is the application of a thin, elastic tape with a thickness similar to the epidermis, on the skin. Being that it can be stretched up to 140 of its original length making it elastic enough compared to the conventional bandages. Kenzo still claims that the tape is able to reduce pain, swelling, muscle spasms and prevent injury. As much as there is today a widespread use of this technique mainly in the context of sports and orthopedics, still lack reliable studies to support the theory described by this method. Objectives: to investigate the influence of application of Kinesio Taping in young athletes in football, muscle strength and muscle activation in the performance of the Single Leg Hop Test tests and Triple Hop Test methods: will be conducted a randomized, placebo-controlled and double-blind. 24 individuals will be athletes who fit the criteria for inclusion will be randomized into 2 groups (Placebo, Kinesio Taping Taping) and will be submitted to the tests of Single Leg Hop Test, Triple Hop Test, the isokinetic evaluation and electromyographic of Rectus Femoris dominant lower limb. Then the intervention shall be carried out with application of Kinesio Taping for activation of rectus femoris muscle group and placebo intervention Kinesio Taping with application of Kinesio Taping of transverse way the rectus femoris without tension in the Placebo group Taping. The volunteers will be re-evaluated 30 minutes after application of the technique and 12:0 am after with the same tests for that later can be compared the results obtained in each group. Analysis: will be achieved statistical tests and adopted a significance level of 5 percent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grupo A (Kinesio Taping) | Active comparator | Procedure: Kinesio TapingWill be held the application of Kinesio Taping (Tex Gold) in the region of the rectus femoris dominant lower limb by a physical therapist trained in the technique (KT1 KT2 and) and with experience in this type of application to be designed without knowing in which group fits this patient. In the sequence, the athlete will be oriented to remain at rest for 30 min to get a better grip on the tape and one of the first tests and rest, only after this period will conduct a new evaluation of jump tests (single leg Hop test and Triple Hop Test) and, finally, a new test of strength in the isokinetic dinamomêtro in conjunction with the electromyographic assessment. |
| Placebo Taping | Placebo comparator | Device: Kinesio Taping placeboThe volunteer will receive a Placebo application tape, being in this case the physical therapist will apply a strip of Kinesio Taping perpendicular to the muscle fibers of the rectus femoris of the dominant member of the individual. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Individuals aged between 15 and 20 years, Football players and Athletes who have body mass index (BMI) considered normal (between 20 and 25).
Key exclusion criteria (1 listed)
- History of lower limb musculoskeletal injuries in the last 6 months, history of lower limb and spine surgery in the last 6 months and BMI over 25 or less than 20.
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 |
|---|---|---|
| Kinesio TapingApplication of Kinesio (Kinesio Tex Gold ®) of black color. The tape will be applied from proximal to distal, leaving the anterosuperior iliac spine Bottom, passing over the Rectus Femoris and ending in the region of the anterior tibia tuberosity with a voltage of 25 %. | Procedure or surgery | Grupo A (Kinesio Taping) |
| Kinesio Taping placeboThe volunteer who is allocated at random in the placebo group will receive an application of Kinesio transverse way the rectus femoris muscle, in order to verify a possible placebo effect of application of tape. | Device | Placebo Taping |
Primary outcome
Hop Test
Time frame: 1 year
The volunteer must position themselves in foot with unipodal support in the dominant lower limb behind a line that will be demarcated on the ground and jump as far as possible, without support in the contralateral limb or imbalance. The distance will be measured with a tape measure, from the starting point (line demarcated on the ground) until the most proximal point of the heel of the foot fell on the floor.
1 secondary outcome
Surface electromyography
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- URL of the University of Nove de JulhoLink 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Kinesio Taping in people with Kinesio Taping, run by University of Nove de Julho at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Feb 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 Brazil. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hop Test (time frame: 1 year). 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 6 Feb 2014.