Struck by Soccer BallNCT02560961
Is Kinesio Taping Better Than Placebo Taping for Improving Performance During Unilateral Vertical Jump and Hop Tests?
A study testing Kinesio Taping (Kinesio Tex Gold®; color: black) in people with Struck by Soccer Ball, run by University of Nove de Julho.
Trial summary
Introduction: Kinesio taping consists of the attachment of a thin elastic tape over specific muscles, the thickness of which is similar to that of the epidermis. This tape can be stretched to 140% of its original length, which demonstrates greater elasticity in comparison to conventional bandages. Read more about this study
- Who is it for?
- Ages 15 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Struck by Soccer Ball
- What is being tested?
- Kinesio Taping (Kinesio Tex Gold®; color: black)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 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 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Practitioners of soccer aged 15 to 20 years with a body mass index (BMI) within the ideal range (20 to 25 Kg/m2)
Who cannot join
- History of musculoskeletal injury in the lower limbs in the previous six months and history of surgery on the lower limbs or back in the previous six months
About this study
Official title: Is Kinesio Taping Better Than Placebo Taping for Improving Performance During Unilateral Vertical Jump and Hop Tests? Protocol Study for a Randomized, Placebo-controlled, Double-blind, Clinical Trials.
Introduction: Kinesio taping consists of the attachment of a thin elastic tape over specific muscles, the thickness of which is similar to that of the epidermis. This tape can be stretched to 140% of its original length, which demonstrates greater elasticity in comparison to conventional bandages. According to the creator of this method, Kinesio taping leads to better muscle activation or inhibition, reduces pain, swelling and muscle spasms and prevents muscle injury. Objective: The aim of the proposed study is to compare and analyze the immediate effect of Kinesio taping and placebo taping on performance during unilateral vertical jump and two hop tests by young professional soccer players. Methods: A randomized, placebo-controlled, double-blind, clinical trial will be conducted involving 100 athletes. The volunteers will be submitted to an evaluation of the dominant lower limb using the Single Leg Hop Test and Single Leg Triple Hop Test as well as the evaluation of a unilateral vertical jump on a pressure platform. The athletes will then be randomly allocated to two groups. Group A will receive Kinesio taping of the triceps surae muscle as described by Kase (2003, 2013) and Group B will receive a placebo taping of the same muscle. After 30 minutes, the volunteers will be submitted to the same evaluation tests. Analysis: Intra-group and inter-group analyses of the results will be performed. Statistical tests will be conducted considering a 5% significance level.
Read the detailed description
Evaluation procedures The consolidated standards of reporting trials (CONSORT) will be used for the proposed randomized clinical trial.
Personal data will be collected using a chart designed by the authors. This chart will contain the following information: name, date of birth, dominant limb, weight and height. Weight and height will be determined using a digital scale (Worker®) and stadiometer (Sanny®), respectively. The dominant limb will be recorded based on the volunteer's answer to a question regarding which leg he would use for a penalty kick. The BMI will be calculated based on weight and height. Individuals with a BMI greater than 25 Kg/m2 or less than 20 Kg/m² will be excluded to standardize the sample.
All volunteers will then undergo the following evaluations:
- Unilateral vertical jump:
The unilateral vertical jump will be used to measure performance, as this movement requires triceps surae strength [9]. The vertical jump will be evaluated using a pressure plate (BIOMEC 400 v1.1® EMG Systems do Brasil) connected to computer (Inter Core 2 Dual®) with 2 GHz and 250 Giga bytes. This system quantifies the distribution of vertical ground reaction force in a static or dynamic position with a sampling frequency of 40 Hz using four force sensors (two anterior and two posterior) capable of supporting 150 Kg. Each sensor stores analog data, which are amplified and converted to digital data interpreted using the Biomec 400® software program (EMG Systems do Brasil). This system records the distribution of force among the four points and changes in body sway in the anteroposterior (Y axis) and mediolateral (X axis) directions. The force plate will be positioned on an even surface. Levelness will be determined by two levels attached to the extremities of the force plate. The volunteer will be instructed to stand on the dominant leg with hands on the hips and jump as high as possible, landing on the same leg. Initially, three jumps will be performed to familiarize the volunteer with the procedure, with a one-minute rest interval between jumps. After a two-minute rest interval, three additional jumps will be performed with a one-minute rest interval between jumps, which will be considered for evaluation. Jump time will be determined using the following formula:
in which h = jump height in meters, t = jump time in seconds and g = acceleration of gravity (9.81 m/s2).
- Single Leg Hop Test Test commonly used to measure functional performance and progression during lower limb rehabilitation programs [10,11,12], with the distance achieved during a single, one-foot hop recorded [11]. For such, the athlete will stand only on the dominant leg behind a line marked on the floor and will hop as far as possible without using the contralateral leg and without losing balance. The distance will be measured with a metric tape from the line marked on the floor to the most proximal point of the heel landing on the floor at the end of the hop . The volunteers will be instructed to keep their hands on their hips throughout the test to reduce the influence of the upper limbs on the performance of the hop test. Initially, three hops will be performed to familiarize the volunteer with the procedure, with a one-minute rest interval between hops. After a two-minute rest interval, three additional hops will be performed with a one-minute rest interval between hops, which will be considered for evaluation.
- Single Leg Triple Hop Test The volunteer will also be positioned on the dominant leg behind the line marked on the floor and will perform three consecutive hops as far as possible without using the contralateral leg and without losing balance. The final distance will be measured with a metric tape from the line marked on the floor to the most proximal point of the heel landing on the floor at the end of the third hop. The volunteers will be instructed to keep their hands on their hips throughout the test to reduce the influence of the upper limbs on the performance of the hop test.
On both hop tests, landing must be made in a stable fashion without touching the contralateral leg or upper limbs to the floor for a hop to be considered valid.
- Conditions
- Struck by Soccer Ball
- Being tested
- Kinesio Taping (Kinesio Tex Gold®; color: black), Placebo Taping
- Keywords
- Kinesio Taping, Soccer, Hop Test, Vertical Jump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio Taping (Kinesio Tex Gold®; color: black)Other
Kinesio Taping technique described by Kase for activation of the triceps surae on the dominant leg will be employed, with the volunteer in the prone position, maintaining the dominant leg off the cot with hip extension, knee extension and ankle dorsiflexion to maintain the triceps surae in a stretched position. The tape will be applied in a Y shape beginning with the origin of the muscle (femur condyles) without tension (Anchor I), passing over the belly of the muscle (therapeutic region) with 15 to 20% tension and ending near the posterior surface of the heel (Anchor II) without tension.
Placebo TapingOther
Standard white bandaging tape will be applied by the same researcher who placed the tape in Group A. The application will be performed the same way as a kinesio taping.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping protocol - Group A | Experimental | Kinesio Taping (Kinesio Tex Gold®; color: black) will be applied by an experienced, duly trained researcher. The technique described by Kase [1] for activation of the triceps surae on the dominant leg will be employed, with the volunteer in the prone position, maintaining the dominant leg off the cot with hip extension, knee extension and ankle dorsiflexion to maintain the triceps surae in a stretched position. The tape will be applied in a Y shape beginning with the origin of the muscle (femur condyles) without tension (Anchor I), passing over the belly of the muscle (therapeutic region) with 15 to 20% tension and ending near the posterior surface of the heel (Anchor II) without tension. Receives: Other: Kinesio Taping (Kinesio Tex Gold®; color: black) |
| Placebo Taping - Group B | Placebo comparator | Standard white bandaging tape will be applied by the same researcher who placed the tape in Group A. The technique described by Kase [1] for activation of the triceps surae on the dominant leg will be employed, with the volunteer in the prone position, maintaining the dominant leg off the cot with hip extension, knee extension and ankle dorsiflexion to maintain the triceps surae in a stretched position. The tape will be applied in a Y shape beginning with the origin of the muscle (femur condyles) and ending near the posterior surface of the heel. Receives: Other: Placebo Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Unilateral vertical jump:
The volunteer will be instructed to stand on the dominant leg with hands on the hips and jump as high as possible, landing on the same leg. Initially, three jumps will be performed to familiarize the volunteer with the procedure, with a one-minute rest interval between jumps. After a two-minute rest interval, three additional jumps will be performed with a one-minute rest interval between jumps, which will be considered for evaluation.
Measured: 10 minutes
Secondary outcomes (1)
• Single Leg Hop Test
For such, the athlete will stand only on the dominant leg behind a line marked on the floor and will hop as far as possible without using the contralateral leg and without losing balance. The distance will be measured with a metric tape from the line marked on the floor to the most proximal point of the heel landing on the floor at the end of the hop [13]. The volunteers will be instructed to keep their hands on their hips throughout the test to reduce the influence of the upper limbs on the performance of the hop test. Initially, three hops will be performed to familiarize the volunteer with the procedure, with a one-minute rest interval between hops. After a two-minute rest interval, three additional hops will be performed with a one-minute rest interval between hops, which will be considered for evaluation.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Struck by Soccer BallStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
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
- Investigators
- Daniela Ap Biasotto-Gonzalez, Doctor, Principal investigator, Universidade Node de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560961
- Sponsor's protocol ID
- Universidade Nove de Julho
- Status last verified
- Feb 2022
- First submitted
- 6 Aug 2015
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Kinesio Taping Better Than Placebo Taping for Improving Performance During Unilateral Vertical Jump and Hop Tests? Protocol Study for a Randomized, Placebo-controlled, Double-blind, Clinical Trials.
- ClinicalTrials.gov ID
- NCT02560961
- Acronym / sponsor ID
- Universidade Nove de Julho
- Conditions
- Struck by Soccer Ball
- Keywords
- Kinesio Taping, Soccer, Hop Test, Vertical Jump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Sep 2015 (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.
Introduction: Kinesio taping consists of the attachment of a thin elastic tape over specific muscles, the thickness of which is similar to that of the epidermis. This tape can be stretched to 140% of its original length, which demonstrates greater elasticity in comparison to conventional bandages. According to the creator of this method, Kinesio taping leads to better muscle activation or inhibition, reduces pain, swelling and muscle spasms and prevents muscle injury. Objective: The aim of the proposed study is to compare and analyze the immediate effect of Kinesio taping and placebo taping on performance during unilateral vertical jump and two hop tests by young professional soccer players. Methods: A randomized, placebo-controlled, double-blind, clinical trial will be conducted involving 100 athletes. The volunteers will be submitted to an evaluation of the dominant lower limb using the Single Leg Hop Test and Single Leg Triple Hop Test as well as the evaluation of a unilateral vertical jump on a pressure platform. The athletes will then be randomly allocated to two groups. Group A will receive Kinesio taping of the triceps surae muscle as described by Kase (2003, 2013) and Group B will receive a placebo taping of the same muscle. After 30 minutes, the volunteers will be submitted to the same evaluation tests. Analysis: Intra-group and inter-group analyses of the results will be performed. Statistical tests will be conducted considering a 5% significance level.
Detailed description
Evaluation procedures The consolidated standards of reporting trials (CONSORT) will be used for the proposed randomized clinical trial.
Personal data will be collected using a chart designed by the authors. This chart will contain the following information: name, date of birth, dominant limb, weight and height. Weight and height will be determined using a digital scale (Worker®) and stadiometer (Sanny®), respectively. The dominant limb will be recorded based on the volunteer's answer to a question regarding which leg he would use for a penalty kick. The BMI will be calculated based on weight and height. Individuals with a BMI greater than 25 Kg/m2 or less than 20 Kg/m² will be excluded to standardize the sample.
All volunteers will then undergo the following evaluations:
- Unilateral vertical jump:
The unilateral vertical jump will be used to measure performance, as this movement requires triceps surae strength [9]. The vertical jump will be evaluated using a pressure plate (BIOMEC 400 v1.1® EMG Systems do Brasil) connected to computer (Inter Core 2 Dual®) with 2 GHz and 250 Giga bytes. This system quantifies the distribution of vertical ground reaction force in a static or dynamic position with a sampling frequency of 40 Hz using four force sensors (two anterior and two posterior) capable of supporting 150 Kg. Each sensor stores analog data, which are amplified and converted to digital data interpreted using the Biomec 400® software program (EMG Systems do Brasil). This system records the distribution of force among the four points and changes in body sway in the anteroposterior (Y axis) and mediolateral (X axis) directions. The force plate will be positioned on an even surface. Levelness will be determined by two levels attached to the extremities of the force plate. The volunteer will be instructed to stand on the dominant leg with hands on the hips and jump as high as possible, landing on the same leg. Initially, three jumps will be performed to familiarize the volunteer with the procedure, with a one-minute rest interval between jumps. After a two-minute rest interval, three additional jumps will be performed with a one-minute rest interval between jumps, which will be considered for evaluation. Jump time will be determined using the following formula:
in which h = jump height in meters, t = jump time in seconds and g = acceleration of gravity (9.81 m/s2).
- Single Leg Hop Test Test commonly used to measure functional performance and progression during lower limb rehabilitation programs [10,11,12], with the distance achieved during a single, one-foot hop recorded [11]. For such, the athlete will stand only on the dominant leg behind a line marked on the floor and will hop as far as possible without using the contralateral leg and without losing balance. The distance will be measured with a metric tape from the line marked on the floor to the most proximal point of the heel landing on the floor at the end of the hop . The volunteers will be instructed to keep their hands on their hips throughout the test to reduce the influence of the upper limbs on the performance of the hop test. Initially, three hops will be performed to familiarize the volunteer with the procedure, with a one-minute rest interval between hops. After a two-minute rest interval, three additional hops will be performed with a one-minute rest interval between hops, which will be considered for evaluation.
- Single Leg Triple Hop Test The volunteer will also be positioned on the dominant leg behind the line marked on the floor and will perform three consecutive hops as far as possible without using the contralateral leg and without losing balance. The final distance will be measured with a metric tape from the line marked on the floor to the most proximal point of the heel landing on the floor at the end of the third hop. The volunteers will be instructed to keep their hands on their hips throughout the test to reduce the influence of the upper limbs on the performance of the hop test.
On both hop tests, landing must be made in a stable fashion without touching the contralateral leg or upper limbs to the floor for a hop to be considered valid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping protocol - Group A | Experimental | Other: Kinesio Taping (Kinesio Tex Gold®; color: black)Kinesio Taping (Kinesio Tex Gold®; color: black) will be applied by an experienced, duly trained researcher. The technique described by Kase [1] for activation of the triceps surae on the dominant leg will be employed, with the volunteer in the prone position, maintaining the dominant leg off the cot with hip extension, knee extension and ankle dorsiflexion to maintain the triceps surae in a stretched position. The tape will be applied in a Y shape beginning with the origin of the muscle (femur condyles) without tension (Anchor I), passing over the belly of the muscle (therapeutic region) with 15 to 20% tension and ending near the posterior surface of the heel (Anchor II) without tension. |
| Placebo Taping - Group B | Placebo comparator | Other: Placebo TapingStandard white bandaging tape will be applied by the same researcher who placed the tape in Group A. The technique described by Kase [1] for activation of the triceps surae on the dominant leg will be employed, with the volunteer in the prone position, maintaining the dominant leg off the cot with hip extension, knee extension and ankle dorsiflexion to maintain the triceps surae in a stretched position. The tape will be applied in a Y shape beginning with the origin of the muscle (femur condyles) and ending near the posterior surface of the heel. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Practitioners of soccer aged 15 to 20 years with a body mass index (BMI) within the ideal range (20 to 25 Kg/m2)
Key exclusion criteria (1 listed)
- History of musculoskeletal injury in the lower limbs in the previous six months and history of surgery on the lower limbs or back in the previous six months
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 Taping (Kinesio Tex Gold®; color: black)Kinesio Taping technique described by Kase for activation of the triceps surae on the dominant leg will be employed, with the volunteer in the prone position, maintaining the dominant leg off the cot with hip extension, knee extension and ankle dorsiflexion to maintain the triceps surae in a stretched position. The tape will be applied in a Y shape beginning with the origin of the muscle (femur condyles) without tension (Anchor I), passing over the belly of the muscle (therapeutic region) with 15 to 20% tension and ending near the posterior surface of the heel (Anchor II) without tension. | Other | Kinesio Taping protocol - Group A |
| Placebo TapingStandard white bandaging tape will be applied by the same researcher who placed the tape in Group A. The application will be performed the same way as a kinesio taping. | Other | Placebo Taping - Group B |
Primary outcome
• Unilateral vertical jump:
Time frame: 10 minutes
The volunteer will be instructed to stand on the dominant leg with hands on the hips and jump as high as possible, landing on the same leg. Initially, three jumps will be performed to familiarize the volunteer with the procedure, with a one-minute rest interval between jumps. After a two-minute rest interval, three additional jumps will be performed with a one-minute rest interval between jumps, which will be considered for evaluation.
1 secondary outcome
• Single Leg Hop Test
Time frame: 15 minutes
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 7 Mar 2022.
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.
Daniela Ap Biasotto-Gonzalez, Doctor principal investigator
Universidade Node de Julho
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping (Kinesio Tex Gold®; color: black) in people with Struck by Soccer Ball, run by University of Nove de Julho.
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: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
• Unilateral vertical jump: (time frame: 10 minutes). 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 7 Mar 2022.