Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000099527
Ethics application status
Approved
Date submitted
22/09/2023
Date registered
2/02/2024
Date last updated
19/10/2024
Date data sharing statement initially provided
2/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
What effects does an ankle taping have on running biomechanics?
Scientific title
Effects of a functional bandage on the electromyographic activation of the ankle muscles and implication in running biomechanics in runners: a cross-over clinical trial
Secondary ID [1] 310662 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle sprain 331559 0
Ankle instability 331560 0
Condition category
Condition code
Musculoskeletal 328298 328298 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: functional taping in the ankle

Arm 1: functional taping, performed with a standard 38-mm self-adhesive tape starting with two anchor strips around the leg 10 cm above the malleoli. The next step will consist of two strips placed from the medial side of the anchor tape to the lateral side with the foot in a neutral position. The “figure sixes” focusing on the subtalar joint will be performed with an initial strip onto the medial anchor through the plantar aspect of the foot attached to the medial anchor. To complete the procedure, the therapist will cover all free ends and spaces with tape.

Arm 2: taping with KinesioTape, performed with a 30 cm "U" strip with 75% tension from the sole to the head of the fibula, following the path of the peroneus longus muscle; then a 15 cm "U" strip with 75% tension from the external part of the calcaneus to the first toe; and finally a 10 cm strip with 75% tension from the external malleolus to the medial malleolus.

All participants will undergo the interventions in a randomized order. The allocation will be carried out using the randomization function of Microsoft Office Excel (Microsoft Corporation, Redmond, Washington, USA).

The bandages will be applied before running by a physiotherapist with ten years of clinical experience specializing in ankle and foot injuries in runners, in the Sports Performance Laboratory of the European University of Madrid.

The minimum duration period between treatments (1- running with taping; 2- running with kinesiotape; 3-running without taping) will be 72h to avoid fatigue, which could interfere with the measures.

First, participants will undergo a maximal effort 5-minute run test on a 400-m track (Berthon et al., 1997; García-Pérez et al., 2013) to determine their maximal aerobic speed. Then (another day), running biomechanics will be measured during a fatigue protocol consisting of a 30-minute run at 85% maximal aerobic speed on a treadmill (García-Pérez et al., 2014).

The participants will carry out this treadmill protocol at 85% maximal aerobic speed for three days: one with a functional bandage (Romero-Morales et al., 2023) applied to the dominant foot, another with a Kinesio tape (Watcharakhueankhan et al., 2022), and another without a bandage. The objective is to observe if the bandages significantly alter the biomechanics and the sensation of stability during the race, and on the other hand to evaluate if significant changes occur in the electromyographic activation of the foot muscles after the race, comparing the different bandages between them.

REFERENCES:

Romero-Morales C, Matilde-Cruz A, García-Arrabe M, Higes-Núñez F, Lópes AD, Saiz SJ, Pareja-Galeano H, López-López D. Assessing the effect of prophylactic ankle taping on ankle and knee biomechanics during landing tasks in healthy individuals: A cross-sectional observational study. Sao Paulo Med J. 2023 Jul 31;142(2):e2022548.

P. Watcharakhueankhan, G.J. Chapman, K. Sinsurin, T. Jaysrichai, J. Richards. The immediate effects of Kinesio Taping on running biomechanics, muscle activity, and perceived changes in comfort, stability and running performance in healthy runners, and the implications to the management of Iliotibial band syndrome. Gait & Posture, 2022;91:179-185.

José Antonio García-Pérez, Pedro Pérez-Soriano, Salvador Llana Belloch, Ángel Gabriel Lucas-Cuevas & Daniel Sánchez-Zuriaga (2014) Effects of treadmill running and fatigue on impact acceleration in distance running, Sports Biomechanics, 13:3, 259-266.
Intervention code [1] 327067 0
Prevention
Comparator / control treatment
Control arm: no bandage
Control group
Active

Outcomes
Primary outcome [1] 336148 0
Composite primary outcome: activation of pronator (peroneus longus and brevis) and supinator (medial gastrocnemius and anterior tibialis) muscles of the foot with an electromyography analysis during a vertical jump (single leg drop jump) before and after performing the treadmill run protocol.

In addition, the characteristics of this jump (jump height in cm, stiffness in kN/m, reactive force index) will be analyzed with the MyJump 2 app (Haynes et al., 2019). In the electromyographic analysis, the following parameters will be assessed: maximum peaks, minimum peaks, and total average (García-Arrabe et al., 2022).

García-Arrabe M, García-Fernández P, Ruiz-Ruiz B, Del Prado-Álvarez R, Romero-Morales C, Díaz-Arribas MJ. Effects of minimalist shoes on pelvic floor activity in nulliparous women during running at different velocities: a randomized cross-over clinical trial. Sci Rep. 2022 Dec 8;12(1):21218. doi: 10.1038/s41598-022-25344-6. PMID: 36481768; PMCID: PMC9732344
Timepoint [1] 336148 0
Baseline (pre-run) and immediately after completion of the 30-minute treadmill running protocol.
Primary outcome [2] 336149 0
Ankle stability
Timepoint [2] 336149 0
Baseline (pre-run) and immediately after completion of the 30-minute treadmill running protocol.
Primary outcome [3] 336150 0
Composite primary outcome: running biomechanics on a treadmill: to analyze running kinematics at the ankle, knee, and hip in the frontal and sagittal planes during the treadmill running protocol, Kinovea software v 0.8.15 will be used, analyzing 2D videos. The variables analyzed will be lateral pelvic drop, hip flexion angle, knee flexion angle, tibial inclination, foot-strike pattern, heel eversion, rearfoot position, forefoot position, and ankle dorsiflexion angle (Damsted et al., 2015; Atkins et al., 2014; Pipkin et al., 2016).

Damsted C, Nielsen RO, Larsen LH. Reliability of video-based quantification of the knee- and hip angle at foot strike during running. Int J Sports Phys Ther. 2015 Apr;10(2):147-54.

Atkins LT, James CR, Sizer PS, Jonely H, Brismée JM. Reliability and concurrent criterion validity of a novel technique for analyzing hip kinematics during running. Physiother Theory Pract. 2014 Apr;30(3):210-7.

Pipkin A, Kotecki K, Hetzel S, Heiderscheit B. Reliability of a Qualitative Video Analysis for Running. J Orthop Sports Phys Ther. 2016 Jul;46(7):556-61.
Timepoint [3] 336150 0
At 5, 15, and 25 minutes during the run
Secondary outcome [1] 427088 0
Ankle dorsiflexion
Timepoint [1] 427088 0
Baseline with or without the bandage, and immediately post-run.

Eligibility
Key inclusion criteria
Male and female well-trained runners between 18 – 45 years old, with a weekly training schedule of at least two days and a total of 15 km of running.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of musculoskeletal lower limb or lumbopelvic pathology in the last year.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation will be determined with the G*Power 3.1.9.2 software (G*Power©, University of Dusseldorf. Germany). Before the sample size calculation, a pilot study will be performed to determine the effect size and mean difference between groups to establish the final total sample size.

The objective is to compare the effects of a kinesiotape and functional tape in well-trained runners on running kinematic biomechanics, stability, and electromyographic activation of ankle muscles during a jump.

To do so, the statistical analysis will be performed with the SPPS software version 29 for Windows. Data distribution will be assessed with the Shapiro-Wilk test or Kolmogorov-Smirnov test. A one-way ANOVA will be performed to analyze the difference between groups during the outdoor trail. A two-way ANOVA of repeated measures will be performed to analyze the difference between groups pre and post the treadmill running protocol. All variables were analyzed individually and multiple comparisons were accounted for using a Bonferroni correction. The significance level will be set at 0,05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2024
Actual
1/03/2024
Date of last participant enrolment
Anticipated
20/03/2024
Actual
10/04/2024
Date of last data collection
Anticipated
25/03/2024
Actual
10/04/2024
Sample size
Target
20
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 25781 0
Spain
State/province [1] 25781 0
Madrid

Funding & Sponsors
Funding source category [1] 314880 0
Self funded/Unfunded
Name [1] 314880 0
Country [1] 314880 0
Primary sponsor type
Individual
Name
María García-Arrabe
Address
Calle Tajo s/n 28670, Villaviciosa de Odón, Madrid
Country
Spain
Secondary sponsor category [1] 316888 0
None
Name [1] 316888 0
Address [1] 316888 0
Country [1] 316888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313878 0
Universidad Europea de Madrid
Ethics committee address [1] 313878 0
Calle Tajo s/n 28670, Villaviciosa de Odón, Madrid
Ethics committee country [1] 313878 0
Spain
Date submitted for ethics approval [1] 313878 0
28/07/2023
Approval date [1] 313878 0
08/09/2023
Ethics approval number [1] 313878 0
2023-282

Summary
Brief summary
The study's primary purpose is to compare the effects of a kinesiotape and functional tape on running kinematic biomechanics during a treadmill running protocol in well-trained runners.

In addition, the study aims to compare the effects of a kinesiotape and functional tape on running kinematic biomechanics during a treadmill protocol in well-trained runners on the following outcomes: ankle stability and electromyographic activation of the pronator and supinator muscles of the ankle during a vertical drop jump.

The hypothesis is that functional taping will be more effective than the Kinesio tape in preventing ankle sprains in trail runners.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129642 0
Dr María García-Arrabe
Address 129642 0
Faculty of Sports Sciences, European University of Madrid. Calle Tajo s/n 28670 Villaviciosa de Odón, Madrid
Country 129642 0
Spain
Phone 129642 0
+34615346292
Fax 129642 0
Email 129642 0
[email protected]
Contact person for public queries
Name 129643 0
María García-Arrabe
Address 129643 0
Faculty of Sports Sciences, European University of Madrid. Calle Tajo s/n 28670 Villaviciosa de Odón, Madrid
Country 129643 0
Spain
Phone 129643 0
+34615346292
Fax 129643 0
Email 129643 0
[email protected]
Contact person for scientific queries
Name 129644 0
María García-Arrabe
Address 129644 0
Faculty of Sports Sciences, European University of Madrid. Calle Tajo s/n 28670 Villaviciosa de Odón, Madrid
Country 129644 0
Spain
Phone 129644 0
+34615346292
Fax 129644 0
Email 129644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.