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Completed

NCT Number: NCT03626051

Ankle Taping and 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.

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.

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Key information

Conditions

Ankle Sprains Ankle Injuries Leg Injuries Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, 112, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 -

Treatment and study plan

Rigid tape

Device

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 tape

Device

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 outcomes

  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 outcomes

  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".

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Effects of Rigid Ankle Tape and Fibular Tape on Functional Performance in Participants With Functional Ankle Instability

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2018
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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