Ankle SprainsNCT03626051
Ankle Taping and Functional Ankle Instability
A study testing Rigid tape and Fibular tape in people with Ankle Sprains, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Background and purpose: Ankle inversion sprains are the commonest injuries of the lower extremities. Taping is routinely used after ankle sprain to support the joint and prevent reinjury. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Rigid tape and Fibular tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Apr 2017to 27 Jun 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants had to have sustained at least two ankle sprain from a sudden inversion trauma, at least one month prior, which resulted in pain and swelling over the lateral ligament and limping, and have at least moderate functional ankle instability
- a score of <27 on the Cumberland Ankle Instability Tool (CAIT)
- anterior drawer test: negative
- talar tilt test: negative
Who cannot join
- if they had sprained their ankle within two weeks of testing
- had a neurological or vestibular disorder or were unable to understand the nature of the protocol and test instructions.
- have received intervention for ankle instability
- PI's research assistant -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Rigid Ankle Tape and Fibular Tape on Functional Performance in Participants With Functional Ankle Instability
Background and purpose:
Ankle inversion sprains are the commonest injuries of the lower extremities. Taping is routinely used after ankle sprain to support the joint and prevent reinjury. The effect of taping on functional performance in participants after ankle sprain has received little attention and generally with inconsistent findings. Besides, the perception of confidence and reassurance that may come with the ankle being taped might lead to the improvement of functional mobility performance. Therefore, the purpose of this study is to investigate the effects of rigid ankle tape and fibular tape on functional performance, self-efficacy and perceived stability, confidence and reassurance during functional tasks in participants with functional ankle instability.
Read more
Methods:
This study is a randomized controlled trial. Forty subjects with functional ankle instability will be recruited and randomly assigned into the rigid tape group and the fibular tape group. Participants will perform functional mobility tests with and without the ankle taped. The functional tests are: figure-8 hopping test, lateral hopping test, star excursion balance test (SEBT), single-leg stance and stair decent test. Secondary outcome measures were self-efficacy and perception measure.
Statistics:
Two-way analysis of variance with repeated measures was used to determine the effects of intervention on each dependent variable. Model effects were group, time (pre, post), and their interaction. Post hoc pairwise comparisons between pre and post in each group, and independent t test between groups, were used to document the difference. The statistical significance was set at p less than 0.05.
- Conditions
- Ankle Sprains
- Being tested
- Rigid tape, Fibular tape
- Keywords
- ankle taping
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid tapeDevice
This taping method used an anchor, two stirrups, three figure-six's (two preventing inversion and one preventing eversion), heel lock and a lock off. Adhesive rigid strapping tape (Leuko Sports Tape, Beiersdorf Australia Ltd, North Ryde) of 3.8 cm thickness was used for all participants
Fibular tapeDevice
This taping method used a rigid strapping tape to reinforce a posterior-superior mobilisation of the distal fibula. Tension was applied on the tape in a posterior and superior direction. Adhesive rigid strapping tape (Leuko Sports Tape, Beiersdorf Australia Ltd, North Ryde) of 3.8 cm thickness was used for all participants
| Study group | Role | What they receive |
|---|---|---|
| rigid tape group | Active comparator | Not described Receives: Device: Rigid tape |
| fibular tape group | Experimental | Not described Receives: Device: Fibular tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Figure-8 hopping test
This test consists of hopping twice around a 5 m course on the test foot in a figure-8, as quickly as possible. The time taken for the participant to complete two circuits of the figure-8 was measured using a stopwatch, and the average of the two best times out of three attempts was recorded.
Measured: Change from baseline at one hour
Lateral hopping test
participants were instructed to hop laterally 30 cm and back for a total of 10 repetitions. The total time was recorded with a handheld stopwatch to the nearest 0.01 second.
Measured: Change from baseline at one hour
Star excursion balance test
This test examined the ability to balance on the affected leg while reaching in various directions with the other foot. Participants stood on the test foot at the central point, and using the other foot reached as far as possible in each of three of the 8 directions of the star excursion balance test (anterior, posterior and postero-medial, relative to the test foot). Only three directions were used due to redundancy among the eight directions. Participants made three attempts in each test direction with the average of the best two attempts for each direction recorded in centimetre
Measured: Change from baseline at one hour
Single-leg stance test
Participants were instructed to balance on one leg for 30 s with their eyes closed, arms at their side, and the other foot touching the medial side of the supporting calf. If they lost their balance, participants were instructed to keep their eyes closed and attempt to re-establish their balance. The number of foot movements made by the stance foot during the 30 s was counted. A foot movement was counted if any of the following occurred: loss of contact with the ground by any part of the foot; a change in foot direction; or each instance when the contralateral foot touched the ground. The lowest total number of foot movements from three attempts was recorded.
Measured: Change from baseline at one hour
Stair decent test
Participants were instructed to run down a flight of 11 stairs as quickly as possible, ensuring that they made contact with every step with one foot, and without using the handrail.The time taken from the first step to touchdown by both feet at the bottom of the flight of stairs was measured. The two best times out of three attempts was averaged.
Measured: Change from baseline at one hour
Secondary outcomes (2)
Self-efficacy questionnaire
The self-efficacy questionnaire was modified from the pain self-efficacy questionnaire, to compare participants' self-reported confidence in performing a range of functionally challenging tasks. The questionnaire consisted of 17 items related to tasks of increasing difficulty. Participants rated their level of confidence in their ability to perform each activity.
Measured: Change from baseline at one hour
Self-perception measure
Three perception measures were recorded at the completion of each functional test to determine whether there was a difference in participants' perceptions between the tape and no tape conditions. Participants recorded their perception of ankle stability, confidence and reassurance. Stability was defined as "how stable your ankle felt during the test", confidence as "how positive you felt during the test", and reassurance as "how safe you felt during the test".
Measured: Change from baseline at one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start6 Apr 2017
- Primary completion29 May 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626051
- Sponsor's protocol ID
- YM106003F
- Status last verified
- Aug 2018
- First submitted
- 6 Apr 2017
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Handoll HH, Rowe BH, Quinn KM, de Bie R. Interventions for preventing ankle ligament injuries. Cochrane Database Syst Rev. 2001;(3):CD000018. doi: 10.1002/14651858.CD000018.
PubMed 11686947Cordova ML, Ingersoll CD, LeBlanc MJ. Influence of ankle support on joint range of motion before and after exercise: a meta-analysis. J Orthop Sports Phys Ther. 2000 Apr;30(4):170-7; discussion 178-82. doi: 10.2519/jospt.2000.30.4.170.
PubMed 10778794Abian-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 19321098Broglio SP, Monk A, Sopiarz K, Cooper ER. The influence of ankle support on postural control. J Sci Med Sport. 2009 May;12(3):388-92. doi: 10.1016/j.jsams.2007.12.010. Epub 2008 Jun 11.
PubMed 18550434Meana M, Alegre LM, Elvira JL, Aguado X. Kinematics of ankle taping after a training session. Int J Sports Med. 2008 Jan;29(1):70-6. doi: 10.1055/s-2007-965126. Epub 2007 Jul 5.
PubMed 17614032MacKean LC, Bell G, Burnham RS. Prophylactic ankle bracing vs. taping: effects on functional performance in female basketball players. J Orthop Sports Phys Ther. 1995 Aug;22(2):77-81. doi: 10.2519/jospt.1995.22.2.77.
PubMed 7581435Verbrugge JD. The effects of semirigid Air-Stirrup bracing vs. adhesive ankle taping on motor performance. J Orthop Sports Phys Ther. 1996 May;23(5):320-5. doi: 10.2519/jospt.1996.23.5.320.
PubMed 8728530Burks RT, Bean BG, Marcus R, Barker HB. Analysis of athletic performance with prophylactic ankle devices. Am J Sports Med. 1991 Mar-Apr;19(2):104-6. doi: 10.1177/036354659101900202.
PubMed 2039059Jerosch J, Thorwesten L, Frebel T, Linnenbecker S. Influence of external stabilizing devices of the ankle on sport-specific capabilities. Knee Surg Sports Traumatol Arthrosc. 1997;5(1):50-7. doi: 10.1007/s001670050025.
PubMed 9127855Paris DL. The Effects of the Swede-O, New Cross, and McDavid Ankle Braces and Adhesive Ankle Taping on Speed, Balance, Agility, and Vertical Jump. J Athl Train. 1992;27(3):253-6.
PubMed 16558170Sawkins K, Refshauge K, Kilbreath S, Raymond J. The placebo effect of ankle taping in ankle instability. Med Sci Sports Exerc. 2007 May;39(5):781-7. doi: 10.1249/MSS.0b013e3180337371.
PubMed 17468574Moiler K, Hall T, Robinson K. The role of fibular tape in the prevention of ankle injury in basketball: A pilot study. J Orthop Sports Phys Ther. 2006 Sep;36(9):661-8. doi: 10.2519/jospt.2006.2259.
PubMed 17017271Gutierrez GM, Kaminski TW, Douex AT. Neuromuscular control and ankle instability. PM R. 2009 Apr;1(4):359-65. doi: 10.1016/j.pmrj.2009.01.013.
PubMed 19627919Hubbard TJ. Ligament laxity following inversion injury with and without chronic ankle instability. Foot Ankle Int. 2008 Mar;29(3):305-11. doi: 10.3113/FAI.2008.0305.
PubMed 18348827Hoch MC, Staton GS, Medina McKeon JM, Mattacola CG, McKeon PO. Dorsiflexion and dynamic postural control deficits are present in those with chronic ankle instability. J Sci Med Sport. 2012 Nov;15(6):574-9. doi: 10.1016/j.jsams.2012.02.009. Epub 2012 May 8.
PubMed 22575498
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rigid Ankle Tape and Fibular Tape on Functional Performance in Participants With Functional Ankle Instability
- ClinicalTrials.gov ID
- NCT03626051
- Acronym / sponsor ID
- YM106003F
- Conditions
- Ankle Sprains
- Keywords
- ankle taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 29 May 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 10 Aug 2018 (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.
Background and purpose:
Ankle inversion sprains are the commonest injuries of the lower extremities. Taping is routinely used after ankle sprain to support the joint and prevent reinjury. The effect of taping on functional performance in participants after ankle sprain has received little attention and generally with inconsistent findings. Besides, the perception of confidence and reassurance that may come with the ankle being taped might lead to the improvement of functional mobility performance. Therefore, the purpose of this study is to investigate the effects of rigid ankle tape and fibular tape on functional performance, self-efficacy and perceived stability, confidence and reassurance during functional tasks in participants with functional ankle instability.
Methods:
This study is a randomized controlled trial. Forty subjects with functional ankle instability will be recruited and randomly assigned into the rigid tape group and the fibular tape group. Participants will perform functional mobility tests with and without the ankle taped. The functional tests are: figure-8 hopping test, lateral hopping test, star excursion balance test (SEBT), single-leg stance and stair decent test. Secondary outcome measures were self-efficacy and perception measure.
Statistics:
Two-way analysis of variance with repeated measures was used to determine the effects of intervention on each dependent variable. Model effects were group, time (pre, post), and their interaction. Post hoc pairwise comparisons between pre and post in each group, and independent t test between groups, were used to document the difference. The statistical significance was set at p less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rigid tape group | Active comparator | Device: Rigid tape |
| fibular tape group | Experimental | Device: Fibular tape |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- participants had to have sustained at least two ankle sprain from a sudden inversion trauma, at least one month prior, which resulted in pain and swelling over the lateral ligament and limping, and have at least moderate functional ankle instability
- a score of <27 on the Cumberland Ankle Instability Tool (CAIT)
- anterior drawer test: negative
- talar tilt test: negative
Key exclusion criteria (4 listed)
- if they had sprained their ankle within two weeks of testing
- had a neurological or vestibular disorder or were unable to understand the nature of the protocol and test instructions.
- have received intervention for ankle instability
- PI's research assistant -
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 |
|---|---|---|
| Rigid tapeThis taping method used an anchor, two stirrups, three figure-six's (two preventing inversion and one preventing eversion), heel lock and a lock off. Adhesive rigid strapping tape (Leuko Sports Tape, Beiersdorf Australia Ltd, North Ryde) of 3.8 cm thickness was used for all participants | Device | rigid tape group |
| Fibular tapeThis taping method used a rigid strapping tape to reinforce a posterior-superior mobilisation of the distal fibula. Tension was applied on the tape in a posterior and superior direction. Adhesive rigid strapping tape (Leuko Sports Tape, Beiersdorf Australia Ltd, North Ryde) of 3.8 cm thickness was used for all participants | Device | fibular tape group |
Primary outcome
Figure-8 hopping test
Time frame: Change from baseline at one hour
This test consists of hopping twice around a 5 m course on the test foot in a figure-8, as quickly as possible. The time taken for the participant to complete two circuits of the figure-8 was measured using a stopwatch, and the average of the two best times out of three attempts was recorded.
Lateral hopping test
Time frame: Change from baseline at one hour
participants were instructed to hop laterally 30 cm and back for a total of 10 repetitions. The total time was recorded with a handheld stopwatch to the nearest 0.01 second.
Star excursion balance test
Time frame: Change from baseline at one hour
This test examined the ability to balance on the affected leg while reaching in various directions with the other foot. Participants stood on the test foot at the central point, and using the other foot reached as far as possible in each of three of the 8 directions of the star excursion balance test (anterior, posterior and postero-medial, relative to the test foot). Only three directions were used due to redundancy among the eight directions. Participants made three attempts in each test direction with the average of the best two attempts for each direction recorded in centimetre
Single-leg stance test
Time frame: Change from baseline at one hour
Participants were instructed to balance on one leg for 30 s with their eyes closed, arms at their side, and the other foot touching the medial side of the supporting calf. If they lost their balance, participants were instructed to keep their eyes closed and attempt to re-establish their balance. The number of foot movements made by the stance foot during the 30 s was counted. A foot movement was counted if any of the following occurred: loss of contact with the ground by any part of the foot; a change in foot direction; or each instance when the contralateral foot touched the ground. The lowest total number of foot movements from three attempts was recorded.
Stair decent test
Time frame: Change from baseline at one hour
Participants were instructed to run down a flight of 11 stairs as quickly as possible, ensuring that they made contact with every step with one foot, and without using the handrail.The time taken from the first step to touchdown by both feet at the bottom of the flight of stairs was measured. The two best times out of three attempts was averaged.
2 secondary outcomes
Self-efficacy questionnaire
Time frame: Change from baseline at one hour
Self-perception measure
Time frame: Change from baseline at one hour
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 10 Aug 2018.
- Results publication: PubMed 11686947Handoll HH, Rowe BH, Quinn KM, de Bie R. Interventions for preventing ankle ligament injuries. Cochrane Database Syst Rev. 2001;(3):CD000018. doi: 10.1002/14651858.CD000018.
- Results publication: PubMed 10778794Cordova ML, Ingersoll CD, LeBlanc MJ. Influence of ankle support on joint range of motion before and after exercise: a meta-analysis. J Orthop Sports Phys Ther. 2000 Apr;30(4):170-7; discussion 178-82. doi: 10.2519/jospt.2000.30.4.170.
- Results publication: 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.
- Results publication: PubMed 18550434Broglio SP, Monk A, Sopiarz K, Cooper ER. The influence of ankle support on postural control. J Sci Med Sport. 2009 May;12(3):388-92. doi: 10.1016/j.jsams.2007.12.010. Epub 2008 Jun 11.
- Results publication: PubMed 17614032Meana M, Alegre LM, Elvira JL, Aguado X. Kinematics of ankle taping after a training session. Int J Sports Med. 2008 Jan;29(1):70-6. doi: 10.1055/s-2007-965126. Epub 2007 Jul 5.
- Results publication: PubMed 7581435MacKean LC, Bell G, Burnham RS. Prophylactic ankle bracing vs. taping: effects on functional performance in female basketball players. J Orthop Sports Phys Ther. 1995 Aug;22(2):77-81. doi: 10.2519/jospt.1995.22.2.77.
- Results publication: PubMed 8728530Verbrugge JD. The effects of semirigid Air-Stirrup bracing vs. adhesive ankle taping on motor performance. J Orthop Sports Phys Ther. 1996 May;23(5):320-5. doi: 10.2519/jospt.1996.23.5.320.
- Results publication: PubMed 2039059Burks RT, Bean BG, Marcus R, Barker HB. Analysis of athletic performance with prophylactic ankle devices. Am J Sports Med. 1991 Mar-Apr;19(2):104-6. doi: 10.1177/036354659101900202.
- Results publication: PubMed 9127855Jerosch J, Thorwesten L, Frebel T, Linnenbecker S. Influence of external stabilizing devices of the ankle on sport-specific capabilities. Knee Surg Sports Traumatol Arthrosc. 1997;5(1):50-7. doi: 10.1007/s001670050025.
- Results publication: PubMed 16558170Paris DL. The Effects of the Swede-O, New Cross, and McDavid Ankle Braces and Adhesive Ankle Taping on Speed, Balance, Agility, and Vertical Jump. J Athl Train. 1992;27(3):253-6.
- Results publication: PubMed 17468574Sawkins K, Refshauge K, Kilbreath S, Raymond J. The placebo effect of ankle taping in ankle instability. Med Sci Sports Exerc. 2007 May;39(5):781-7. doi: 10.1249/MSS.0b013e3180337371.
- Results publication: PubMed 17017271Moiler K, Hall T, Robinson K. The role of fibular tape in the prevention of ankle injury in basketball: A pilot study. J Orthop Sports Phys Ther. 2006 Sep;36(9):661-8. doi: 10.2519/jospt.2006.2259.
- Individual participant dataSharing planned: Undecided
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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 Rigid tape and Fibular tape in people with Ankle Sprains, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 4 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 10 Aug 2018. 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 Taiwan. 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?
Figure-8 hopping test (time frame: Change from baseline at one hour). The study lists 5 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 NCT03626051, which also lists 32 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 10 Aug 2018.