NCT03626051

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2017

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

April 6, 2017

Last Update Submit

August 7, 2018

Conditions

Keywords

ankle taping

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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

    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.

    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.

    Change from baseline at one hour

Secondary Outcomes (2)

  • Self-efficacy questionnaire

    Change from baseline at one hour

  • Self-perception measure

    Change from baseline at one hour

Study Arms (2)

rigid tape group

ACTIVE COMPARATOR
Device: Rigid tape

fibular tape group

EXPERIMENTAL
Device: Fibular tape

Interventions

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

rigid tape group

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

fibular tape group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

Related Publications (32)

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  • Cordova 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.

  • Abian-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.

  • Broglio 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.

  • Meana 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.

  • MacKean 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.

  • Verbrugge 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.

  • Burks 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.

  • Jerosch 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.

  • Paris 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.

  • Sawkins 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.

  • Moiler 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.

  • Gutierrez 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.

  • Hubbard 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.

  • Hoch 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.

  • Denegar CR, Hertel J, Fonseca J. The effect of lateral ankle sprain on dorsiflexion range of motion, posterior talar glide, and joint laxity. J Orthop Sports Phys Ther. 2002 Apr;32(4):166-73. doi: 10.2519/jospt.2002.32.4.166.

  • Whitman JM, Cleland JA, Mintken PE, Keirns M, Bieniek ML, Albin SR, Magel J, McPoil TG. Predicting short-term response to thrust and nonthrust manipulation and exercise in patients post inversion ankle sprain. J Orthop Sports Phys Ther. 2009 Mar;39(3):188-200. doi: 10.2519/jospt.2009.2940.

  • Wikstrom EA, Hubbard TJ. Talar positional fault in persons with chronic ankle instability. Arch Phys Med Rehabil. 2010 Aug;91(8):1267-71. doi: 10.1016/j.apmr.2010.04.022.

  • Hopkins JT, Brown TN, Christensen L, Palmieri-Smith RM. Deficits in peroneal latency and electromechanical delay in patients with functional ankle instability. J Orthop Res. 2009 Dec;27(12):1541-6. doi: 10.1002/jor.20934.

  • Munn J, Sullivan SJ, Schneiders AG. Evidence of sensorimotor deficits in functional ankle instability: a systematic review with meta-analysis. J Sci Med Sport. 2010 Jan;13(1):2-12. doi: 10.1016/j.jsams.2009.03.004. Epub 2009 May 12.

  • Van Deun S, Staes FF, Stappaerts KH, Janssens L, Levin O, Peers KK. Relationship of chronic ankle instability to muscle activation patterns during the transition from double-leg to single-leg stance. Am J Sports Med. 2007 Feb;35(2):274-81. doi: 10.1177/0363546506294470. Epub 2006 Dec 27.

  • Mitchell A, Dyson R, Hale T, Abraham C. Biomechanics of ankle instability. Part 1: Reaction time to simulated ankle sprain. Med Sci Sports Exerc. 2008 Aug;40(8):1515-21. doi: 10.1249/mss.0b013e31817356b6.

  • Mitchell A, Dyson R, Hale T, Abraham C. Biomechanics of ankle instability. Part 2: Postural sway-reaction time relationship. Med Sci Sports Exerc. 2008 Aug;40(8):1522-8. doi: 10.1249/MSS.0b013e31817356d6.

  • 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.

  • Delahunt E, McGrath A, Doran N, Coughlan GF. Effect of taping on actual and perceived dynamic postural stability in persons with chronic ankle instability. Arch Phys Med Rehabil. 2010 Sep;91(9):1383-9. doi: 10.1016/j.apmr.2010.06.023.

  • Halim-Kertanegara S, Raymond J, Hiller CE, Kilbreath SL, Refshauge KM. The effect of ankle taping on functional performance in participants with functional ankle instability. Phys Ther Sport. 2017 Jan;23:162-167. doi: 10.1016/j.ptsp.2016.03.005. Epub 2016 Apr 18.

  • Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.

  • Docherty CL, Arnold BL, Gansneder BM, Hurwitz S, Gieck J. Functional-Performance Deficits in Volunteers With Functional Ankle Instability. J Athl Train. 2005 Mar;40(1):30-34.

  • Munro AG, Herrington LC. Between-session reliability of the star excursion balance test. Phys Ther Sport. 2010 Nov;11(4):128-32. doi: 10.1016/j.ptsp.2010.07.002. Epub 2010 Aug 17.

  • Olmsted LC, Carcia CR, Hertel J, Shultz SJ. Efficacy of the Star Excursion Balance Tests in Detecting Reach Deficits in Subjects With Chronic Ankle Instability. J Athl Train. 2002 Dec;37(4):501-506.

  • Hiller CE, Refshauge KM, Herbert RD, Kilbreath SL. Balance and recovery from a perturbation are impaired in people with functional ankle instability. Clin J Sport Med. 2007 Jul;17(4):269-75. doi: 10.1097/JSM.0b013e3180f60b12.

  • Hiller CE, Refshauge KM, Herbert RD, Kilbreath SL. Intrinsic predictors of lateral ankle sprain in adolescent dancers: a prospective cohort study. Clin J Sport Med. 2008 Jan;18(1):44-8. doi: 10.1097/JSM.0b013e31815f2b35.

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2017

First Posted

August 10, 2018

Study Start

April 6, 2017

Primary Completion

May 29, 2017

Study Completion

June 27, 2017

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations