BalanceNCT03219905
Does "Kinesio-taping" Affect Balance in Healthy Individuals?
A study testing Therapeutic Kinesio-taping in people with Balance, run by Ankara University.
Trial summary
Kinesio-taping (KT) has recently gained so much popularity and a growing number of physicians started using it to alleviate musculoskeletal symptoms. It was originally developed by Kenzo Kase in 1976. The effects of KT on ankle proprioception and stability have been investigated in previous studies. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Therapeutic Kinesio-taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jun 2014
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Age between 18-40 years
- polyneuropathy or neurological deficits
Who cannot join
- Individuals with;
- lower extremity fractures
- knee or ankle ligamentous injury
- conditions affecting balance, knee, hip or spinal osteoarthritis
- lower extremity or back surgery
- polyneuropathy or neurological deficits
About this study
Official title: Does "Kinesio-taping" Affect Standing Balance in Healthy Individuals? A Randomized Controlled Pilot Trial
Kinesio-taping (KT) has recently gained so much popularity and a growing number of physicians started using it to alleviate musculoskeletal symptoms. It was originally developed by Kenzo Kase in 1976. The effects of KT on ankle proprioception and stability have been investigated in previous studies. However, these studies are limited and the current data is conflicting. Repeated application of KT in a patient with chronic ankle instability has been shown to be effective in improving balance. In basketball players with chronic ankle sprain, KT did not improve or inhibit balance. Application of KT did not cause a significant change in balance of healthy subjects. The aim of this study was to evaluate the immediate and short-term effects of KT on balance of healthy subjects.
Read the detailed description
Thirty male healthy volunteers (between 18-40 ages) were screened for eligibility by physical examination and history. Informed written consent was obtained from all participants before enrollment. The research proposal was reviewed and approved by the Faculty Ethics Committee(No: 05-213-14).
This is a randomized sham controlled, double-blind pilot clinical trial. The block randomization method with a block size of 4 was used in order to allocate the subjects equally into two groups; Kinesiotaping (KT) and sham (control).To conceal the randomization sequence an independent researcher (HG) who is unaware of the baseline data carried out the procedure using a computer software. The researcher (MO) who was blinded to the allocationprocedure did the balance testing of all subjects, before (t0), immediately after (t1) and 24 hours after the application of KT (T2). The subjects were also blinded to the type of intervention.
Standard 2-inch (5-cm) Kinesio® Tex (Kinesio Holding Corporation, Albuquerque, NM) Tape was used for all applications in both groups. A certified KT practitioner (BST) did the all taping procedures. KT was applied bilaterally to the ankle joints. To ensure blinding of the assessor (MÖ), taping procedure was done in a separate room and subjects wore their socks after the application. The tape remained in place for 24 hours duration and subjects were instructed to participate in their normal daily activities, except shower.
The experimental group received a standardized therapeutic Kinesio Tape application. Three "I" strips were applied to the both ankle joints for joint stability with subject's ankle at 90 degrees. KT was applied according to the procedures recommended by the website of http://www.kttapeeurope.com/How-to-tape-Ankle-Stability (last accessed on July 7th, 2017). First strip was anchored 5 cm above the ankle. Then tape was applied down the outer ankle, across the bottom of the heel, and up the inner side of the ankle. The last 5cm of tape was laid without stretch. Second strip was anchored along the instep of the foot. Then tape was laid around the back of the heel and across the arch with 50% stretch. The last part of tape was laid down without stretch on inside of foot. Third strip was anchored same style along the outside of the foot. The tape was laid the around the back of the heel and across the arch with 50% stretch. The last 5 cm of the tape was laid down without stretch on insideof foot. The control group received a sham Kinesio Tape application. Ankle position was hold at minimally plantar flexion during taping. A"I" strip was placed from the anterior midfoot, not stretched and attached to the midline of anterior leg.
Each participant's height and weight were recorded and body mass index (BMI) was calculated. Balance measurements were made with a stabilometer, BiodexTM Balance System. A dynamic postural stability test was performed in a double-leg standing position with eyes open. Each test included three trials that lasted 20 seconds with a 10-second rest period between them. A mean score was calculated from three trials. Subjects were given a practice trial lasting 20 sec. to familiarize with the test. During the dynamic postural stability test three indices were calculated; (1) anteroposterior stability index (APSI), (2) mediolateral stability index (MLSI), (3) overall stability index (OSI). The OSI indicates the total variation in plate deviation (sway) from the horizontal plane. The APSI and MLSI indicate the deviation of the plate (sway) from the horizontal position in the sagittal and frontal planes, respectively. Since the values obtained during measurements indicate the amount of sway from the horizontal position, lower scores show better balance.
Non-parametric tests have been used due to the small sample size and skewed data distribution. The baseline demographic characteristics of the patients in each group were compared by Mann Whitney U test. The two-way mixed ANOVA was used to compare the mean differences between independent groups over time and to understand if there is an interaction between time and group factors.
- Conditions
- Balance
- Being tested
- Therapeutic Kinesio-taping, Sham Kinesio-taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Kinesio-tapingDevice
The experimental group received a therapeutic Kinesio Tape application. Three "I" strips were applied to the both ankle joints for joint stability with subject's ankle at 90 degrees.
Sham Kinesio-tapingDevice
The control group received a sham Kinesio Tape application. Ankle position was hold at minimally plantar flexion during taping. A"I" strip was placed from the anterior midfoot, not stretched and attached to the midline of anterior leg.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio-taping Group | Experimental | Therapeutic Kinesio-taping Receives: Device: Therapeutic Kinesio-taping |
| Control Group | Sham comparator | Sham Kinesio-taping Receives: Device: Sham Kinesio-taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediolateral stability index (MLSI)
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Measured: Change from Baseline in MLSI immediately after KT application
Mediolateral stability index (MLSI)
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Measured: Change from Baseline in MLSI 24 hours after KT application
Secondary outcomes (4)
Anteroposterior stability index (APSI)
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Measured: Change from Baseline in APSI immediately after KT application
Anteroposterior stability index (APSI)
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Measured: Change from Baseline in APSI 24 hours after KT application
Overall stability index (OSI)
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Measured: Change from Baseline in OSI immediately after KT application
Overall stability index (OSI)
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Measured: Change from Baseline in OSI 24 hours after KT application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
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 BalanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haydar Gok, Ankara University
- Investigators
- Haydar Gok, Professor, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219905
- Sponsor's protocol ID
- 05-213-14
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wikstrom EA, Tillman MD, Kline KJ, Borsa PA. Gender and limb differences in dynamic postural stability during landing. Clin J Sport Med. 2006 Jul;16(4):311-5. doi: 10.1097/00042752-200607000-00005.
PubMed 16858214Gabriel RC, Abrantes J, Granata K, Bulas-Cruz J, Melo-Pinto P, Filipe V. Dynamic joint stiffness of the ankle during walking: gender-related differences. Phys Ther Sport. 2008 Feb;9(1):16-24. doi: 10.1016/j.ptsp.2007.08.002. Epub 2007 Sep 29.
PubMed 19083700Akbari 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 24926148Tamburella F, Scivoletto G, Molinari M. Somatosensory inputs by application of KinesioTaping: effects on spasticity, balance, and gait in chronic spinal cord injury. Front Hum Neurosci. 2014 May 30;8:367. doi: 10.3389/fnhum.2014.00367. eCollection 2014.
PubMed 24910607Cortesi M, Cattaneo D, Jonsdottir J. Effect of kinesio taping on standing balance in subjects with multiple sclerosis: A pilot study\m1. NeuroRehabilitation. 2011;28(4):365-72. doi: 10.3233/NRE-2011-0665.
PubMed 21725170Kinzey SJ, Ingersoll CD, Knight KL. The effects of selected ankle appliances on postural control. J Athl Train. 1997 Oct;32(4):300-3.
PubMed 16558462Nunes GS, de Noronha M, Cunha HS, Ruschel C, Borges NG Jr. Effect of kinesio taping on jumping and balance in athletes: a crossover randomized controlled trial. J Strength Cond Res. 2013 Nov;27(11):3183-9. doi: 10.1519/JSC.0b013e31828a2c17.
PubMed 23439339Shields CA, Needle AR, Rose WC, Swanik CB, Kaminski TW. Effect of elastic taping on postural control deficits in subjects with healthy ankles, copers, and individuals with functional ankle instability. Foot Ankle Int. 2013 Oct;34(10):1427-35. doi: 10.1177/1071100713491076. Epub 2013 May 29.
PubMed 23720530Nakajima MA, Baldridge C. The effect of kinesio(R) tape on vertical jump and dynamic postural control. Int J Sports Phys Ther. 2013 Aug;8(4):393-406.
PubMed 24175126You SH, Granata KP, Bunker LK. Effects of circumferential ankle pressure on ankle proprioception, stiffness, and postural stability: a preliminary investigation. J Orthop Sports Phys Ther. 2004 Aug;34(8):449-60. doi: 10.2519/jospt.2004.34.8.449.
PubMed 15373008
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does "Kinesio-taping" Affect Standing Balance in Healthy Individuals? A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT03219905
- Acronym / sponsor ID
- 05-213-14
- Conditions
- Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Jul 2017 (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.
Kinesio-taping (KT) has recently gained so much popularity and a growing number of physicians started using it to alleviate musculoskeletal symptoms. It was originally developed by Kenzo Kase in 1976. The effects of KT on ankle proprioception and stability have been investigated in previous studies. However, these studies are limited and the current data is conflicting. Repeated application of KT in a patient with chronic ankle instability has been shown to be effective in improving balance. In basketball players with chronic ankle sprain, KT did not improve or inhibit balance. Application of KT did not cause a significant change in balance of healthy subjects. The aim of this study was to evaluate the immediate and short-term effects of KT on balance of healthy subjects.
Detailed description
Thirty male healthy volunteers (between 18-40 ages) were screened for eligibility by physical examination and history. Informed written consent was obtained from all participants before enrollment. The research proposal was reviewed and approved by the Faculty Ethics Committee(No: 05-213-14).
This is a randomized sham controlled, double-blind pilot clinical trial. The block randomization method with a block size of 4 was used in order to allocate the subjects equally into two groups; Kinesiotaping (KT) and sham (control).To conceal the randomization sequence an independent researcher (HG) who is unaware of the baseline data carried out the procedure using a computer software. The researcher (MO) who was blinded to the allocationprocedure did the balance testing of all subjects, before (t0), immediately after (t1) and 24 hours after the application of KT (T2). The subjects were also blinded to the type of intervention.
Standard 2-inch (5-cm) Kinesio® Tex (Kinesio Holding Corporation, Albuquerque, NM) Tape was used for all applications in both groups. A certified KT practitioner (BST) did the all taping procedures. KT was applied bilaterally to the ankle joints. To ensure blinding of the assessor (MÖ), taping procedure was done in a separate room and subjects wore their socks after the application. The tape remained in place for 24 hours duration and subjects were instructed to participate in their normal daily activities, except shower.
The experimental group received a standardized therapeutic Kinesio Tape application. Three "I" strips were applied to the both ankle joints for joint stability with subject's ankle at 90 degrees. KT was applied according to the procedures recommended by the website of http://www.kttapeeurope.com/How-to-tape-Ankle-Stability (last accessed on July 7th, 2017). First strip was anchored 5 cm above the ankle. Then tape was applied down the outer ankle, across the bottom of the heel, and up the inner side of the ankle. The last 5cm of tape was laid without stretch. Second strip was anchored along the instep of the foot. Then tape was laid around the back of the heel and across the arch with 50% stretch. The last part of tape was laid down without stretch on inside of foot. Third strip was anchored same style along the outside of the foot. The tape was laid the around the back of the heel and across the arch with 50% stretch. The last 5 cm of the tape was laid down without stretch on insideof foot. The control group received a sham Kinesio Tape application. Ankle position was hold at minimally plantar flexion during taping. A"I" strip was placed from the anterior midfoot, not stretched and attached to the midline of anterior leg.
Each participant's height and weight were recorded and body mass index (BMI) was calculated. Balance measurements were made with a stabilometer, BiodexTM Balance System. A dynamic postural stability test was performed in a double-leg standing position with eyes open. Each test included three trials that lasted 20 seconds with a 10-second rest period between them. A mean score was calculated from three trials. Subjects were given a practice trial lasting 20 sec. to familiarize with the test. During the dynamic postural stability test three indices were calculated; (1) anteroposterior stability index (APSI), (2) mediolateral stability index (MLSI), (3) overall stability index (OSI). The OSI indicates the total variation in plate deviation (sway) from the horizontal plane. The APSI and MLSI indicate the deviation of the plate (sway) from the horizontal position in the sagittal and frontal planes, respectively. Since the values obtained during measurements indicate the amount of sway from the horizontal position, lower scores show better balance.
Non-parametric tests have been used due to the small sample size and skewed data distribution. The baseline demographic characteristics of the patients in each group were compared by Mann Whitney U test. The two-way mixed ANOVA was used to compare the mean differences between independent groups over time and to understand if there is an interaction between time and group factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio-taping Group | Experimental | Device: Therapeutic Kinesio-tapingTherapeutic Kinesio-taping |
| Control Group | Sham comparator | Device: Sham Kinesio-tapingSham Kinesio-taping |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers
- Age between 18-40 years
- polyneuropathy or neurological deficits
Key exclusion criteria (6 listed)
- Individuals with;
- lower extremity fractures
- knee or ankle ligamentous injury
- conditions affecting balance, knee, hip or spinal osteoarthritis
- lower extremity or back surgery
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 |
|---|---|---|
| Therapeutic Kinesio-tapingThe experimental group received a therapeutic Kinesio Tape application. Three "I" strips were applied to the both ankle joints for joint stability with subject's ankle at 90 degrees. | Device | Kinesio-taping Group |
| Sham Kinesio-tapingThe control group received a sham Kinesio Tape application. Ankle position was hold at minimally plantar flexion during taping. A"I" strip was placed from the anterior midfoot, not stretched and attached to the midline of anterior leg. | Device | Control Group |
Primary outcome
Mediolateral stability index (MLSI)
Time frame: Change from Baseline in MLSI immediately after KT application
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Mediolateral stability index (MLSI)
Time frame: Change from Baseline in MLSI 24 hours after KT application
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
4 secondary outcomes
Anteroposterior stability index (APSI)
Time frame: Change from Baseline in APSI immediately after KT application
Anteroposterior stability index (APSI)
Time frame: Change from Baseline in APSI 24 hours after KT application
Overall stability index (OSI)
Time frame: Change from Baseline in OSI immediately after KT application
Overall stability index (OSI)
Time frame: Change from Baseline in OSI 24 hours after KT application
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 18 Jul 2017.
- Background: PubMed 16858214Wikstrom EA, Tillman MD, Kline KJ, Borsa PA. Gender and limb differences in dynamic postural stability during landing. Clin J Sport Med. 2006 Jul;16(4):311-5. doi: 10.1097/00042752-200607000-00005.
- Background: PubMed 19083700Gabriel RC, Abrantes J, Granata K, Bulas-Cruz J, Melo-Pinto P, Filipe V. Dynamic joint stiffness of the ankle during walking: gender-related differences. Phys Ther Sport. 2008 Feb;9(1):16-24. doi: 10.1016/j.ptsp.2007.08.002. Epub 2007 Sep 29.
- 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.
- Background: PubMed 24910607Tamburella F, Scivoletto G, Molinari M. Somatosensory inputs by application of KinesioTaping: effects on spasticity, balance, and gait in chronic spinal cord injury. Front Hum Neurosci. 2014 May 30;8:367. doi: 10.3389/fnhum.2014.00367. eCollection 2014.
- Background: PubMed 21725170Cortesi M, Cattaneo D, Jonsdottir J. Effect of kinesio taping on standing balance in subjects with multiple sclerosis: A pilot study\m1. NeuroRehabilitation. 2011;28(4):365-72. doi: 10.3233/NRE-2011-0665.
- Background: PubMed 16558462Kinzey SJ, Ingersoll CD, Knight KL. The effects of selected ankle appliances on postural control. J Athl Train. 1997 Oct;32(4):300-3.
- Background: PubMed 23439339Nunes GS, de Noronha M, Cunha HS, Ruschel C, Borges NG Jr. Effect of kinesio taping on jumping and balance in athletes: a crossover randomized controlled trial. J Strength Cond Res. 2013 Nov;27(11):3183-9. doi: 10.1519/JSC.0b013e31828a2c17.
- Background: PubMed 23720530Shields CA, Needle AR, Rose WC, Swanik CB, Kaminski TW. Effect of elastic taping on postural control deficits in subjects with healthy ankles, copers, and individuals with functional ankle instability. Foot Ankle Int. 2013 Oct;34(10):1427-35. doi: 10.1177/1071100713491076. Epub 2013 May 29.
- Background: PubMed 24175126Nakajima MA, Baldridge C. The effect of kinesio(R) tape on vertical jump and dynamic postural control. Int J Sports Phys Ther. 2013 Aug;8(4):393-406.
- Background: PubMed 15373008You SH, Granata KP, Bunker LK. Effects of circumferential ankle pressure on ankle proprioception, stiffness, and postural stability: a preliminary investigation. J Orthop Sports Phys Ther. 2004 Aug;34(8):449-60. doi: 10.2519/jospt.2004.34.8.449.
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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.
Haydar Gok, Professor principal investigator
Ankara University
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Kinesio-taping in people with Balance, run by Ankara University.
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 3 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 18 Jul 2017. 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?
Mediolateral stability index (MLSI) (time frame: Change from Baseline in MLSI immediately after KT application). 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 NCT03219905, 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 18 Jul 2017.