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Ankle Taping and Functional Ankle Instability

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ClinicalTrials.gov Identifier: NCT03626051
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Yea-Ru Yang, National Yang Ming University

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.


Condition or disease Intervention/treatment Phase
Ankle Sprains Device: Rigid tape Device: Fibular tape Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Rigid Ankle Tape and Fibular Tape on Functional Performance in Participants With Functional Ankle Instability
Actual Study Start Date : April 6, 2017
Actual Primary Completion Date : May 29, 2017
Actual Study Completion Date : June 27, 2017

Arm Intervention/treatment
Active Comparator: rigid tape group Device: Rigid tape
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

Experimental: fibular tape group Device: Fibular tape
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Self-efficacy questionnaire [ Time Frame: Change from baseline at one hour ]
    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.

  2. Self-perception measure [ Time Frame: Change from baseline at one hour ]
    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".



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. a score of <27 on the Cumberland Ankle Instability Tool (CAIT)
  3. anterior drawer test: negative
  4. talar tilt test: negative

Exclusion Criteria:

  1. if they had sprained their ankle within two weeks of testing
  2. had a neurological or vestibular disorder or were unable to understand the nature of the protocol and test instructions.
  3. have received intervention for ankle instability
  4. PI's research assistant -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626051


Locations
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Taiwan
National Yang-Ming University
Taipei, Taiwan, 112
Sponsors and Collaborators
National Yang Ming University
Publications of Results:

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Responsible Party: Yea-Ru Yang, Professor, National Yang Ming University
ClinicalTrials.gov Identifier: NCT03626051    
Other Study ID Numbers: YM106003F
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yea-Ru Yang, National Yang Ming University:
ankle taping
Additional relevant MeSH terms:
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Ankle Injuries
Leg Injuries
Wounds and Injuries