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Ankle Taping and Functional Ankle Instability

Primary Purpose

Ankle Sprains

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Rigid tape

Fibular tape

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring ankle taping

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

rigid tape group

fibular tape group

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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

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.

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.

Secondary Outcome Measures

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.

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".

Full Information

NCT ID

NCT03626051

First Posted

April 6, 2017

Last Updated

August 7, 2018

Sponsor

National Yang Ming University

1. Study Identification

Unique Protocol Identification Number

NCT03626051

Brief Title

Ankle Taping and Functional Ankle Instability

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

April 6, 2017 (Actual)

Primary Completion Date

May 29, 2017 (Actual)

Study Completion Date

June 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Sprains

Keywords

ankle taping

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rigid tape group

Arm Type

Active Comparator

Arm Title

fibular tape group

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Rigid tape

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Fibular tape

Intervention Description

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 Measure Information:

Title

Figure-8 hopping test

Description

Time Frame