InjuryNCT04059575
Is Kinesio Taping Application Effective on Decreasing Injury Risk for Tennis Players
A study testing Kinesio Taping (Performance Plus) and Kinesio taping (Gold Tex) in people with Injury, run by Guven Health Group at 1 site in Turkey (Türkiye).
Trial summary
Research design: The study protocol was approved and required permissions were taken from related tennis club officials, and a written consent was obtained from all the participants' parents about the study. Thirty-three young tennis players aged between 9 and 12 were included in our study. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury
- What is being tested?
- Kinesio Taping (Performance Plus) and Kinesio taping (Gold Tex)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2020to 30 Jan 2021
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- at least playing tennis 2 years
- to be between 9 and 12 years
- no any sport activity-only tennis
- to be a volunteer
Who cannot join
- with soft tissue or bone problems affecting lower extremity,
- who had acute inflammation affecting lower extremity region,
- had scoliosis,
- who had undergone any orthopedic surgery,
- who had defined any pain or painful area at lower extremities and
- who were obese (BMI>30 kg/m2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Kind of Kinesio Taping Material Should be Used to Decrease the Injury Risk Better
Research design: The study protocol was approved and required permissions were taken from related tennis club officials, and a written consent was obtained from all the participants' parents about the study. Thirty-three young tennis players aged between 9 and 12 were included in our study. Assessment were done bare (no tape), after 45 min of performance plus kinesio taping application (PP application) and after 45 min of gold text FP kinesio taping application (GT application). We were randomly taped with either PP or GT taping applications using an online random allocation software program (GraphPad Software QuickCalcs, GraphPad Software Inc., La Jolla, CA, USA). Thirty min of rest was given between 2 taping applications after the removal of the first tape. One participant was not able to complete the second taping procedure. PP and GT taping applications were done by using kinesio taping muscle facilitation techniques to Quadriceps and Gastrosoleus muscles. I-shaped tape with a tension of 10-35% was used for muscle facilitation. All patients were assessed by an experienced physiotherapist, and the tapings were done by another experienced physiotherapist in order to provide a single blind structure of the study.
Read the detailed description
Participants: Thirty-three young tennis players aged between 9 and 12 yrs were recruited in the study. The exclusion criteria included those (a) with soft tissue or bone problems affecting lower extremity, (b) who had acute inflammation affecting lower extremity region, (c) had scoliosis, (d) who had undergone any orthopedic surgery, (e) who had defined any pain or painful area at lower extremities and (f) who were obese (BMI>30 kg/m2).
Assessments: Thermal analysis was done for risk of injury including both lower extremities. Quadriceps muscle was chosen from upper leg and gastro soleus muscle was chosen from lower leg region for thermal analysis. The thermo graphic assessment was performed by using FLIR E5 (FLIR Systems AB, Sweden) thermal camera in order to evaluate which muscles had the highest thermal activity while maintaining stable upright posture. The part of muscle with more activation (greater heat) was measured by the thermo graphic camera and the heat was recorded in centigrade. Each participant was thermo graphically evaluated in the same room (ambient temperature, 21°C) and participants were left for 10-20 minutes to 'acclimatize' to the thermographic imaging environment FLIR E5 Thermal Camera, with a resolution of 120 x 90 pixels was used for thermal imaging and the Color Palette iron was chosen for displaying the images. It is indicated that IR imaging may be a reliable and valid measure of treatment outcomes with clinical utility and sensitivity
The power analysis indicated that 33 participants for total were needed with 80 % power and a 5 % type 1 error. The power analysis of our study showed a power of 80% with tissue temperature as the primary outcome. The data were analyzed using statistical software (SPSS version 18, Inc., Chicago, IL, USA). All the statistical analyses were set a priori at an alpha level of p<0.05. The tests for homogeneity (Levene's test) and normality (Shapiro-Wilk) were used to determine the appropriate statistical methods. According to the test results, nonparametric Friedman test was used for comparisons between baseline, first taping and last taping. Wilcoxon test was used for possible differences which may occur between taping applications in order to identify the application that provided the difference. Parametric test assumptions were not possible due to small sample size and inhomogeneous parameters.
- Conditions
- Injury
- Being tested
- Kinesio Taping (Performance Plus), Kinesio taping (Gold Tex)
- Keywords
- tennis, vertical jump, kinesio taping, thermography
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio Taping (Performance Plus)Other
PP and GT taping applications were done by using kinesio taping muscle facilitation techniques to Quadriceps and Gastrosoleus muscles. I tape with a tension of 10-35% was used for muscle facilitation. All patients were assessed by an experienced physiotherapist, and the tapings were done by another experienced physiotherapist in order to provide a single blind structure of the study.
Kinesio taping (Gold Tex)Other
PP and GT taping applications were done by using kinesio taping muscle facilitation techniques to Quadriceps and Gastrosoleus muscles. I tape with a tension of 10-35% was used for muscle facilitation. All patients were assessed by an experienced physiotherapist, and the tapings were done by another experienced physiotherapist in order to provide a single blind structure of the study.
| Study group | Role | What they receive |
|---|---|---|
| PERFORMANCE PLUS | Experimental | performance plus better than GOLD TEX Receives: Other: Kinesio Taping (Performance Plus) |
| GOLD TEX | Active comparator | GOLD TEX better than performance plus Receives: Other: Kinesio taping (Gold Tex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
termal analysis
Quadriceps muscle was chosen from upper leg and gastro soleus muscle was chosen from lower leg region for thermal analysis. The thermo graphic assessment was performed by using FLIR E5 (FLIR Systems AB, Sweden) thermal camera in order to evaluate which muscles had the highest thermal activity while maintaining stable upright posture. The part of muscle with more activation (greater heat) was measured by the thermo graphic camera and the heat was recorded in centigrade. Each participant was thermo graphically evaluated in the same room (ambient temperature, 21°C) and participants were left for 10-20 minutes to 'acclimatize' to the thermographic imaging environment FLIR E5 Thermal Camera, with a resolution of 120 x 90 pixels was used for thermal imaging.
Measured: 2 hours
vertical jump
A vertical jump test was performed before and after the application of Kinesio taping® to their quadriceps and gastrocnemius muscles according to Kase's recommendations. The height and flight time data was collected using a portable optical timing system (Optojump Next; Microgate, Bolzano, Italy) during a counter movement jump. Mean maximum jump height and flight time were averaged from three attempts. Two-way repeated measures ANOVAs were used to assess the influence taping condition on vertical jump performance.
Measured: 1 hours
Secondary outcomes (1)
age
Sports age is important to determine the description of differences between ages and sexes.
Measured: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start24 Sep 2020
- Primary completion25 Dec 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InjuryStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- The part of muscle with more activation (greater heat) was measured by the thermo graphic camera and the heat was recorded in centigrade. Each participant was thermo graphically evaluated in the same room (ambient temperature, 21°C) and participants were left for 10-20 minutes to 'acclimatize' to the thermographic imaging environment FLIR E5 Thermal Camera, with a resolution of 120 x 90 pixels was used for thermal imaging and the Color Palette iron was chosen for displaying the images. It is indicated that IR imaging may be a reliable and valid measure of treatment outcomes with clinical utility and sensitivity
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guven Health Group
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Baskent University
- Responsible party
- Principal investigator, GUL BALTACI, Guven Health Group
- Investigators
- YESIM S CETINKAYA, MD, Study director, Guven Health Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059575
- Sponsor's protocol ID
- 511
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Each participant was thermo graphically evaluated in the same room (ambient temperature, 21°C) and participants were left for 10-20 minutes to 'acclimatize' to the thermographic imaging environment FLIR E5 Thermal Camera, with a resolution of 120 x 90 pixels was used for thermal imaging and the Color Palette iron was chosen for displaying the images. It is indicated that IR imaging may be a reliable and valid measure of treatment outcomes with clinical utility and sensitivity
Publications
Bicici S, Karatas N, Baltaci G. Effect of athletic taping and kinesiotaping(R) on measurements of functional performance in basketball players with chronic inversion ankle sprains. Int J Sports Phys Ther. 2012 Apr;7(2):154-66.
PubMed 22530190Kirmizigil B, Chauchat JR, Yalciner O, Iyigun G, Angin E, Baltaci G. The Effectiveness of Kinesio Taping in Recovering From Delayed Onset Muscle Soreness: A Crossover Study. J Sport Rehabil. 2019 Oct 18;29(4):385-393. doi: 10.1123/jsr.2018-0389. Print 2020 May 1.
PubMed 30860409Thomas MG, Mohan D, Sahasi G, Prabhu GG. Personality and attitude correlates of drug abuse amongst students of a high school in Delhi: a replicated study. Indian J Med Res. 1979 Jun;69:990-5. No abstract available.
PubMed 468356
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Kind of Kinesio Taping Material Should be Used to Decrease the Injury Risk Better
- ClinicalTrials.gov ID
- NCT04059575
- Acronym / sponsor ID
- 511
- Conditions
- Injury
- Keywords
- tennis, vertical jump, kinesio taping, thermography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Guven Health GroupUniversity, hospital or other
- Collaborators
- Hacettepe University, Baskent University
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 16 Aug 2019 (actual)
- 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.
Research design: The study protocol was approved and required permissions were taken from related tennis club officials, and a written consent was obtained from all the participants' parents about the study. Thirty-three young tennis players aged between 9 and 12 were included in our study. Assessment were done bare (no tape), after 45 min of performance plus kinesio taping application (PP application) and after 45 min of gold text FP kinesio taping application (GT application). We were randomly taped with either PP or GT taping applications using an online random allocation software program (GraphPad Software QuickCalcs, GraphPad Software Inc., La Jolla, CA, USA). Thirty min of rest was given between 2 taping applications after the removal of the first tape. One participant was not able to complete the second taping procedure. PP and GT taping applications were done by using kinesio taping muscle facilitation techniques to Quadriceps and Gastrosoleus muscles. I-shaped tape with a tension of 10-35% was used for muscle facilitation. All patients were assessed by an experienced physiotherapist, and the tapings were done by another experienced physiotherapist in order to provide a single blind structure of the study.
Detailed description
Participants: Thirty-three young tennis players aged between 9 and 12 yrs were recruited in the study. The exclusion criteria included those (a) with soft tissue or bone problems affecting lower extremity, (b) who had acute inflammation affecting lower extremity region, (c) had scoliosis, (d) who had undergone any orthopedic surgery, (e) who had defined any pain or painful area at lower extremities and (f) who were obese (BMI>30 kg/m2).
Assessments: Thermal analysis was done for risk of injury including both lower extremities. Quadriceps muscle was chosen from upper leg and gastro soleus muscle was chosen from lower leg region for thermal analysis. The thermo graphic assessment was performed by using FLIR E5 (FLIR Systems AB, Sweden) thermal camera in order to evaluate which muscles had the highest thermal activity while maintaining stable upright posture. The part of muscle with more activation (greater heat) was measured by the thermo graphic camera and the heat was recorded in centigrade. Each participant was thermo graphically evaluated in the same room (ambient temperature, 21°C) and participants were left for 10-20 minutes to 'acclimatize' to the thermographic imaging environment FLIR E5 Thermal Camera, with a resolution of 120 x 90 pixels was used for thermal imaging and the Color Palette iron was chosen for displaying the images. It is indicated that IR imaging may be a reliable and valid measure of treatment outcomes with clinical utility and sensitivity
The power analysis indicated that 33 participants for total were needed with 80 % power and a 5 % type 1 error. The power analysis of our study showed a power of 80% with tissue temperature as the primary outcome. The data were analyzed using statistical software (SPSS version 18, Inc., Chicago, IL, USA). All the statistical analyses were set a priori at an alpha level of p<0.05. The tests for homogeneity (Levene's test) and normality (Shapiro-Wilk) were used to determine the appropriate statistical methods. According to the test results, nonparametric Friedman test was used for comparisons between baseline, first taping and last taping. Wilcoxon test was used for possible differences which may occur between taping applications in order to identify the application that provided the difference. Parametric test assumptions were not possible due to small sample size and inhomogeneous parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The part of muscle with more activation (greater heat) was measured by the thermo graphic camera and the heat was recorded in centigrade. Each participant was thermo graphically evaluated in the same room (ambient temperature, 21°C) and participants were left for 10-20 minutes to 'acclimatize' to the thermographic imaging environment FLIR E5 Thermal Camera, with a resolution of 120 x 90 pixels was used for thermal imaging and the Color Palette iron was chosen for displaying the images. It is indicated that IR imaging may be a reliable and valid measure of treatment outcomes with clinical utility and sensitivity
| Arm | Type | Receives |
|---|---|---|
| PERFORMANCE PLUS | Experimental | Other: Kinesio Taping (Performance Plus)performance plus better than GOLD TEX |
| GOLD TEX | Active comparator | Other: Kinesio taping (Gold Tex)GOLD TEX better than performance plus |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- at least playing tennis 2 years
- to be between 9 and 12 years
- no any sport activity-only tennis
- to be a volunteer
Key exclusion criteria (6 listed)
- with soft tissue or bone problems affecting lower extremity,
- who had acute inflammation affecting lower extremity region,
- had scoliosis,
- who had undergone any orthopedic surgery,
- who had defined any pain or painful area at lower extremities and
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 (Performance Plus)PP and GT taping applications were done by using kinesio taping muscle facilitation techniques to Quadriceps and Gastrosoleus muscles. I tape with a tension of 10-35% was used for muscle facilitation. All patients were assessed by an experienced physiotherapist, and the tapings were done by another experienced physiotherapist in order to provide a single blind structure of the study. | Other | PERFORMANCE PLUS |
| Kinesio taping (Gold Tex)PP and GT taping applications were done by using kinesio taping muscle facilitation techniques to Quadriceps and Gastrosoleus muscles. I tape with a tension of 10-35% was used for muscle facilitation. All patients were assessed by an experienced physiotherapist, and the tapings were done by another experienced physiotherapist in order to provide a single blind structure of the study. | Other | GOLD TEX |
Primary outcome
termal analysis
Time frame: 2 hours
Quadriceps muscle was chosen from upper leg and gastro soleus muscle was chosen from lower leg region for thermal analysis. The thermo graphic assessment was performed by using FLIR E5 (FLIR Systems AB, Sweden) thermal camera in order to evaluate which muscles had the highest thermal activity while maintaining stable upright posture. The part of muscle with more activation (greater heat) was measured by the thermo graphic camera and the heat was recorded in centigrade. Each participant was thermo graphically evaluated in the same room (ambient temperature, 21°C) and participants were left for 10-20 minutes to 'acclimatize' to the thermographic imaging environment FLIR E5 Thermal Camera, with a resolution of 120 x 90 pixels was used for thermal imaging.
vertical jump
Time frame: 1 hours
A vertical jump test was performed before and after the application of Kinesio taping® to their quadriceps and gastrocnemius muscles according to Kase's recommendations. The height and flight time data was collected using a portable optical timing system (Optojump Next; Microgate, Bolzano, Italy) during a counter movement jump. Mean maximum jump height and flight time were averaged from three attempts. Two-way repeated measures ANOVAs were used to assess the influence taping condition on vertical jump performance.
1 secondary outcome
age
Time frame: through study completion, an average of 8 weeks
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 4 Feb 2021.
- Results publication: PubMed 22530190Bicici S, Karatas N, Baltaci G. Effect of athletic taping and kinesiotaping(R) on measurements of functional performance in basketball players with chronic inversion ankle sprains. Int J Sports Phys Ther. 2012 Apr;7(2):154-66.
- Results publication: PubMed 30860409Kirmizigil B, Chauchat JR, Yalciner O, Iyigun G, Angin E, Baltaci G. The Effectiveness of Kinesio Taping in Recovering From Delayed Onset Muscle Soreness: A Crossover Study. J Sport Rehabil. 2019 Oct 18;29(4):385-393. doi: 10.1123/jsr.2018-0389. Print 2020 May 1.
- Results publication: PubMed 468356Thomas MG, Mohan D, Sahasi G, Prabhu GG. Personality and attitude correlates of drug abuse amongst students of a high school in Delhi: a replicated study. Indian J Med Res. 1979 Jun;69:990-5. No abstract available.
- Kinesiotaping related articlesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Each participant was thermo graphically evaluated in the same room (ambient temperature, 21°C) and participants were left for 10-20 minutes to 'acclimatize' to the thermographic imaging environment FLIR E5 Thermal Camera, with a resolution of 120 x 90 pixels was used for thermal imaging and the Color Palette iron was chosen for displaying the images. It is indicated that IR imaging may be a reliable and valid measure of treatment outcomes with clinical utility and sensitivity
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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.
YESIM S CETINKAYA, MD study director
Guven Health Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping (Performance Plus) and Kinesio taping (Gold Tex) in people with Injury, run by Guven Health Group at 1 site in Turkey (Türkiye).
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 6 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 4 Feb 2021. 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 Turkey (Türkiye). 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. 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?
termal analysis (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 NCT04059575, which also lists 3 linked publications.
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 4 Feb 2021.