Injury of Musculoskeletal SystemNCT02863562
Study of the Effect of Kinesio Taping and Proprioceptive Exercise on the Stability of Ankle in Amateur Soccer Players
A study testing Kinesio taping and Proprioceptive exercises in people with Injury of Musculoskeletal System, run by University of Valencia at 1 site in Spain.
Trial summary
Soccer is a sport that attracts many participants and leads to a substantial number of injuries, especially of the ankle. Enhancement of functional joint stability by kinesio taping proprioceptive training may be important both in prevention and rehabilitation of ankle injuries. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Injury of Musculoskeletal System
- What is being tested?
- Kinesio taping and Proprioceptive exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Apr 2017
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be older than 18 years old.
- To be soccer player for more than 5 years.
Who cannot join
- Serious illness.
- Recent ankle injury
- Vestibulocerebellar disorder
- Allergy to Kinesio taping
- Inability to complete all interventional sessions for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Soccer is a sport that attracts many participants and leads to a substantial number of injuries, especially of the ankle. Enhancement of functional joint stability by kinesio taping proprioceptive training may be important both in prevention and rehabilitation of ankle injuries. The main aim of this study was to determine the effect of kinesio taping and proprioceptive exercises on parameters related to ankle stability, such as the injury incidence, pain, static or dynamic stability and flexibility, in amateur soccer players training 3 times a week.
- Conditions
- Injury of Musculoskeletal System
- Being tested
- Kinesio taping, Proprioceptive exercises, Placebo Kinesio taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
Kinesio taping technique was used on both ankles on the first day of training with the aim of functional and mechanical correction, following the method described by Duenas et al. It was removed on the second day of training. This procedure was repeated each week for one month.
Proprioceptive exercisesOther
Proprioceptive exercises were performed twice a week for one month. They were incorporated into their normal training routine (twice per week), and included 20 min of standardised proprioceptive exercises: single leg balancing on stable surfaces, on bosu/togu balls, and hopping activities, all repeated with eyes open/closed.
Placebo Kinesio tapingOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | This group included 16 subjects. They received kinesio taping for both ankle joints and and performed proprioceptive exercises.
Proprioceptive exercises were incorporated into their normal training routine (twice per week), and included 20 min of standardised proprioceptive exercises: single leg balancing on stable surfaces, on bosu/togu balls, and hopping activities, all repeated with eyes open/closed. Kinesio taping technique was used on both ankles on the first day of training with the aim of functional and mechanical correction, following the method described by Duenas et al. It was removed on the second day of training. Receives: Other: Kinesio taping; Other: Proprioceptive exercises |
| Group 2 | Experimental | This group received placebo kinesio taping for ankle joint (no tension) and performed proprioceptive exercises.
Proprioceptive exercises were incorporated into their normal training routine (twice per week), and included 20 min of standardised proprioceptive exercises: single leg balancing on stable surfaces, on bosu/togu balls, and hopping activities, all repeated with eyes open/closed. Kinesio taping technique was used on both ankles on the first day of training in the same way as before but with no tension. It was removed on the second day of training. Receives: Other: Proprioceptive exercises; Other: Placebo Kinesio taping |
| Group 3 | Experimental | This group received kinesio taping for ankle joint. Kinesio taping technique was used on both ankles on the first day of training with the aim of functional and mechanical correction, following the method described by Duenas et al. It was removed on the second day of training. Receives: Other: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance
Assessed by the Star Excursion Balance Test (SEBT). The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception. The goal of the SEBT is to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg. Subjects are instructed to stand with both feet positioned inside the boundaries of the starting box. A trial initiates when the subject begins to reach in one of the four diagonal directions. In this study anterior, posteromedial and posterolateral directions will be evaluated. When reaching along the lines to the subject's right, the subject uses his right leg to reach while using his left leg as the support limb and vice versa. Subjects are not allowed to touch the ground with the reaching leg at any time during the reach. The maximal reach distance is the furthest point along the directional line.
Measured: 8 weeks
Static balance
Assessed by the Unipedal Stance Test. Subjects are asked to close their eyes and to stand barefoot on the limb of their choice, with the other limb raised so that the raised foot is near but not touching the ankle of their stance limb. Prior to raising the limb, the subject is instructed to cross his arms over the chest. The investigator uses a stopwatch to measure the amount of time the subject is able to stand on one limb. Time commences when the subject raises the foot off the floor. Time ends when the subject either: (1) uses his arms (ie, uncrossed arms), (2) uses the raised foot (moves it toward or away from the standing limb or touches the floor), (3) moves the weight-bearing foot to maintain his balance (ie, rotates foot on the ground), (4) a maximum of 45 seconds has elapsed, or (5) opens eyes. The procedure is repeated 3 times and each time was recorded on the data collection sheet. The average of the 3 trials is recorded.
Measured: 8 weeks
Flexibility
Assessed by the toe touch test. The subject stands on a box with his feet together and toes pointing forward. He is asked to bend from the hips forward and try to touch the ends of his fingers to the tips of your toes, without bending his knees. He should go as far as possible without pain, and try to keep his knees straight through the whole test. The distance to the basal line (top of the box) or over it is measured by a flexible tape.
Measured: 8 weeks
Secondary outcomes (1)
Pain
It was assessed by the FAAM questionaire (0= no pain; 10= great pain)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Injury of Musculoskeletal SystemStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Inglés de la Torre, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863562
- Sponsor's protocol ID
- H1449680900364
- Status last verified
- Apr 2017
- First submitted
- 8 Aug 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dvorak J, Junge A. Football injuries and physical symptoms. A review of the literature. Am J Sports Med. 2000;28(5 Suppl):S3-9. doi: 10.1177/28.suppl_5.s-3.
PubMed 11032101Cruz-Diaz D, Lomas-Vega R, Osuna-Perez MC, Contreras FH, Martinez-Amat A. Effects of 6 Weeks of Balance Training on Chronic Ankle Instability in Athletes: A Randomized Controlled Trial. Int J Sports Med. 2015 Aug;36(9):754-60. doi: 10.1055/s-0034-1398645. Epub 2015 May 13.
PubMed 25969966Abian-Vicen J, Alegre LM, Fernandez-Rodriguez JM, Aguado X. Prophylactic ankle taping: elastic versus inelastic taping. Foot Ankle Int. 2009 Mar;30(3):218-25. doi: 10.3113/FAI.2009.0218.
PubMed 19321098Bicici 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 22530190Han J, Anson J, Waddington G, Adams R, Liu Y. The Role of Ankle Proprioception for Balance Control in relation to Sports Performance and Injury. Biomed Res Int. 2015;2015:842804. doi: 10.1155/2015/842804. Epub 2015 Oct 25.
PubMed 26583139Akbari A, Sarmadi A, Zafardanesh P. The effect of ankle taping and balance exercises on postural stability indices in healthy women. J Phys Ther Sci. 2014 May;26(5):763-9. doi: 10.1589/jpts.26.763. Epub 2014 May 29.
PubMed 24926148Dueñas, L., Balasch, M., & Espí, G. (2010). Técnicas y nuevas aplicaciones del vendaje neuromuscular. Barcelona: Lettera Publicaciones.
Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.
PubMed 16309613Kinzey SJ, Armstrong CW. The reliability of the star-excursion test in assessing dynamic balance. J Orthop Sports Phys Ther. 1998 May;27(5):356-60. doi: 10.2519/jospt.1998.27.5.356.
PubMed 9580895Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.
PubMed 19839175
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Kinesio Taping and Proprioceptive Exercise on the Stability of Ankle in Amateur Soccer Players
- ClinicalTrials.gov ID
- NCT02863562
- Acronym / sponsor ID
- H1449680900364
- Conditions
- Injury of Musculoskeletal System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 Aug 2016 (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.
Soccer is a sport that attracts many participants and leads to a substantial number of injuries, especially of the ankle. Enhancement of functional joint stability by kinesio taping proprioceptive training may be important both in prevention and rehabilitation of ankle injuries. The main aim of this study was to determine the effect of kinesio taping and proprioceptive exercises on parameters related to ankle stability, such as the injury incidence, pain, static or dynamic stability and flexibility, in amateur soccer players training 3 times a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Kinesio taping, Other: Proprioceptive exercisesThis group included 16 subjects. They received kinesio taping for both ankle joints and and performed proprioceptive exercises. Proprioceptive exercises were incorporated into their normal training routine (twice per week), and included 20 min of standardised proprioceptive exercises: single leg balancing on stable surfaces, on bosu/togu balls, and hopping activities, all repeated with eyes open/closed. Kinesio taping technique was used on both ankles on the first day of training with the aim of functional and mechanical correction, following the method described by Duenas et al. It was removed on the second day of training. |
| Group 2 | Experimental | Other: Proprioceptive exercises, Other: Placebo Kinesio tapingThis group received placebo kinesio taping for ankle joint (no tension) and performed proprioceptive exercises. Proprioceptive exercises were incorporated into their normal training routine (twice per week), and included 20 min of standardised proprioceptive exercises: single leg balancing on stable surfaces, on bosu/togu balls, and hopping activities, all repeated with eyes open/closed. Kinesio taping technique was used on both ankles on the first day of training in the same way as before but with no tension. It was removed on the second day of training. |
| Group 3 | Experimental | Other: Kinesio tapingThis group received kinesio taping for ankle joint. Kinesio taping technique was used on both ankles on the first day of training with the aim of functional and mechanical correction, following the method described by Duenas et al. It was removed on the second day of training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be older than 18 years old.
- To be soccer player for more than 5 years.
Key exclusion criteria (5 listed)
- Serious illness.
- Recent ankle injury
- Vestibulocerebellar disorder
- Allergy to Kinesio taping
- Inability to complete all interventional sessions for any reason
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 tapingKinesio taping technique was used on both ankles on the first day of training with the aim of functional and mechanical correction, following the method described by Duenas et al. It was removed on the second day of training. This procedure was repeated each week for one month. | Other | Group 1, Group 3 |
| Proprioceptive exercisesProprioceptive exercises were performed twice a week for one month. They were incorporated into their normal training routine (twice per week), and included 20 min of standardised proprioceptive exercises: single leg balancing on stable surfaces, on bosu/togu balls, and hopping activities, all repeated with eyes open/closed. | Other | Group 1, Group 2 |
| Placebo Kinesio taping | Other | Group 2 |
Primary outcome
Dynamic balance
Time frame: 8 weeks
Assessed by the Star Excursion Balance Test (SEBT). The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception. The goal of the SEBT is to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg. Subjects are instructed to stand with both feet positioned inside the boundaries of the starting box. A trial initiates when the subject begins to reach in one of the four diagonal directions. In this study anterior, posteromedial and posterolateral directions will be evaluated. When reaching along the lines to the subject's right, the subject uses his right leg to reach while using his left leg as the support limb and vice versa. Subjects are not allowed to touch the ground with the reaching leg at any time during the reach. The maximal reach distance is the furthest point along the directional line.
Static balance
Time frame: 8 weeks
Assessed by the Unipedal Stance Test. Subjects are asked to close their eyes and to stand barefoot on the limb of their choice, with the other limb raised so that the raised foot is near but not touching the ankle of their stance limb. Prior to raising the limb, the subject is instructed to cross his arms over the chest. The investigator uses a stopwatch to measure the amount of time the subject is able to stand on one limb. Time commences when the subject raises the foot off the floor. Time ends when the subject either: (1) uses his arms (ie, uncrossed arms), (2) uses the raised foot (moves it toward or away from the standing limb or touches the floor), (3) moves the weight-bearing foot to maintain his balance (ie, rotates foot on the ground), (4) a maximum of 45 seconds has elapsed, or (5) opens eyes. The procedure is repeated 3 times and each time was recorded on the data collection sheet. The average of the 3 trials is recorded.
Flexibility
Time frame: 8 weeks
Assessed by the toe touch test. The subject stands on a box with his feet together and toes pointing forward. He is asked to bend from the hips forward and try to touch the ends of his fingers to the tips of your toes, without bending his knees. He should go as far as possible without pain, and try to keep his knees straight through the whole test. The distance to the basal line (top of the box) or over it is measured by a flexible tape.
1 secondary outcome
Pain
Time frame: 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 Apr 2017.
- Background: PubMed 11032101Dvorak J, Junge A. Football injuries and physical symptoms. A review of the literature. Am J Sports Med. 2000;28(5 Suppl):S3-9. doi: 10.1177/28.suppl_5.s-3.
- Background: PubMed 25969966Cruz-Diaz D, Lomas-Vega R, Osuna-Perez MC, Contreras FH, Martinez-Amat A. Effects of 6 Weeks of Balance Training on Chronic Ankle Instability in Athletes: A Randomized Controlled Trial. Int J Sports Med. 2015 Aug;36(9):754-60. doi: 10.1055/s-0034-1398645. Epub 2015 May 13.
- Background: PubMed 19321098Abian-Vicen J, Alegre LM, Fernandez-Rodriguez JM, Aguado X. Prophylactic ankle taping: elastic versus inelastic taping. Foot Ankle Int. 2009 Mar;30(3):218-25. doi: 10.3113/FAI.2009.0218.
- Background: 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.
- Background: PubMed 26583139Han J, Anson J, Waddington G, Adams R, Liu Y. The Role of Ankle Proprioception for Balance Control in relation to Sports Performance and Injury. Biomed Res Int. 2015;2015:842804. doi: 10.1155/2015/842804. Epub 2015 Oct 25.
- Background: PubMed 24926148Akbari A, Sarmadi A, Zafardanesh P. The effect of ankle taping and balance exercises on postural stability indices in healthy women. J Phys Ther Sci. 2014 May;26(5):763-9. doi: 10.1589/jpts.26.763. Epub 2014 May 29.
- BackgroundDueñas, L., Balasch, M., & Espí, G. (2010). Técnicas y nuevas aplicaciones del vendaje neuromuscular. Barcelona: Lettera Publicaciones.
- Background: PubMed 16309613Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.
- Background: PubMed 9580895Kinzey SJ, Armstrong CW. The reliability of the star-excursion test in assessing dynamic balance. J Orthop Sports Phys Ther. 1998 May;27(5):356-60. doi: 10.2519/jospt.1998.27.5.356.
- Background: PubMed 19839175Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Proprioceptive exercises in people with Injury of Musculoskeletal System, run by University of Valencia 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 2 inclusion and 5 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 Apr 2017. 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. 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?
Dynamic balance (time frame: 8 weeks). The study lists 3 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 NCT02863562, which also lists 10 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 Apr 2017.