Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000773336
Ethics application status
Approved
Date submitted
24/05/2017
Date registered
26/05/2017
Date last updated
15/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of how rigid strapping tape fatigue impacts ankle and knee function during a cutting task
Scientific title
An investigation of how rigid strapping tape fatigue impacts ankle and knee function during a cutting task
Secondary ID [1] 292011 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb biomechanics 303398 0
Condition category
Condition code
Musculoskeletal 302811 302811 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project will be considering the use of rigid strapping tape applied to the ankle, how it impacts biomechanical function at the ankle and knee, and if ankle and knee function changes as the tape fatigues. For this reason, the intervention will be the application of rigid strapping tape to the ankles of participants.

The testing involved will require a single testing session conducted in the Charles Sturt University (Albury) Gait Lab, and will take approximately 30-45 minutes. Prior to attending the testing session the participant will have looked over the information form, and completed the Consent Form, the Physical Activity Readiness Questionnaire (PAR-Q), and the Activity and Injury Questionnaire. These will be reviewed on arrival to ensure the potential participant is safe to complete testing. All testing will be carried out by two honours students and one supervisor. The honours students are third year students in the Podiatry undergraduate course. All researchers have current first aid training. The supervisor has both Human Movement and Podiatry undergraduate qualifications, and over 10 years clinical experience.

The testing will start with the researchers measuring the participant’s height, weight and hip measurements and lower limb dimensions. At the early stage of testing each participant will be randomly assigned to one of two groups. Group one will have their ankles strapped using rigid strapping tape (Elastoplast woven strapping tape with adhesive backing - 5am width) and a standard strapping technique (combination of anchor, two stirrups, a figure 6 strap, two heel locks, and a second anchor - consistent with that described in the 'Sports Medicine for Sports Trainers' manual - 2007), Group two will not require any strapping tape to be applied. The participant will be asked to wear a chest strap heart rate monitor as one of the fatigue measures during testing. This will be applied prior to mark-up which will allow us to obtain resting heart rate measures. Reflective markers will be placed on the skin of both lower limbs and torso. These markers will allow recording of movement during the dynamic activities with 3D cameras. Using standard, non-invasive procedures, both lower limbs will be prepared and surface electrodes placed on the skin at selected muscle sites. This will allow measurement of muscle activity during the movement tasks. After completing a low intensity 5-minute treadmill warm-up, the participant will be guided through a series of activities which will serve the purpose of the fatigue protocol. These activities will include lateral shuffles, forward/backward running, agility ladder, figure-of-8, forward running with a 45 degree cut task, wall jumps, jumping over cones, and zigzags. The participant will be free to complete the activities at their own pace, although we will ask that they complete the tasks at a high velocity which they find comfortable. The physical tasks will be repeated for 20 minutes. Recording of the 45 degree cut task will occur at 0min, 5min, 10min, 15min and 20min intervals while the fatigue protocol is being completed. Recording will involve 3D motion analysis, as well as the use of EMG (Electromyography), heart rate and ground reaction force. The participant will also be asked to complete a rating of perceived exertion (RPE) at the previously identified time intervals to help gauge fatigue levels. Upon completion the participant will have all markers, sensors and the heart rate monitor removed, and will be offered a guided five minute treadmill cool down and stretching.
Intervention code [1] 298146 0
Treatment: Devices
Comparator / control treatment
As there are two groups, a tape group and a no-tape group, the no-tape group will act as the control in this particular study. The intervention group will include those who have strapping tape applied to their ankles. All participants will be asked to complete identical activities for assessment and to produce fatigue.
Control group
Active

Outcomes
Primary outcome [1] 302196 0
The primary outcome will be the impact of rigid strapping tape fatigue on ankle joint range of motion during a dynamic task. This will rely on ankle inversion/eversion results (3D motion analysis) and fibularis muscle activity (EMG). The fatigue of the participant will also be factored in as a contributor with the use of heart rate assessment and rating of perceived exertion.
Timepoint [1] 302196 0
Performance of a cut task will be performed at 0min, 5min, 10min, 15min and 20min to understand how physical fatigue (and tape fatigue in the tape group) influence dynamic range of motion at the ankle during a dynamic cut task.
Secondary outcome [1] 335153 0
The secondary outcome will be the effect of rigid strapping tape applied to the ankle on knee function. This will assess the knee joint in the sagittal and frontal planes (3D motion analysis), The fatigue of the tape and the participant will be considered when interpreting these results (heart rate and rating of perceived exertion).
Timepoint [1] 335153 0
Performance of a cut task will be performed at 0min, 5min, 10min, 15min and 20min to understand how physical fatigue (and tape fatigue in the tape group) influence dynamic range of motion at the knee during a dynamic cut task.

Eligibility
Key inclusion criteria
Participants should be:
- Between the ages of 18 and 35
- Free of neurovasulcar, vascular or musculoskeletal injury
- Not pregnant
- Not dependent on medical care
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded on the following grounds:
- Younger than 18 or older than 35
- Currently experiencing a neurovasulcar, vascular or musculoskeletal injury
- Currently pregnant

Study design
Purpose of the study
Treatment
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)
Participants will be required to select one of six numbered balls from a plastic container. Even numbers will be allocated to the no-tape control group, odd numbers will be allocated to the tape intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study will be aiming to recruit a minimum of 42 participants. G*Power was used to complete the sample size calculations. Given that we will be comparing a tape group with a no tape group ‘Means: Difference between two independent means (two groups)’ was chosen as the statistical test. A large effect size of 0.8 was chosen, as we would expect clinical significance to require more obvious changes to occur. The alpha level of error was entered as 0.05, which will assume our findings will have occurred by chance only 5% of the time. In aiming for a power of 80%, this will require a sample of 42 participants (21 ankle tape, 21 no ankle tape).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2017
Actual
24/07/2017
Date of last participant enrolment
Anticipated
17/07/2018
Actual
20/09/2017
Date of last data collection
Anticipated
17/07/2018
Actual
20/09/2017
Sample size
Target
42
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 16133 0
2640 - Thurgoona

Funding & Sponsors
Funding source category [1] 296537 0
University
Name [1] 296537 0
Charles Sturt University
Country [1] 296537 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
PO Box 789
Albury NSW 2640
Country
Australia
Secondary sponsor category [1] 295494 0
None
Name [1] 295494 0
Address [1] 295494 0
Country [1] 295494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297757 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 297757 0
Human Research Ethics Committee
Office of Academic Governance
Charles Sturt University
Panorama Avenue
Bathurst NSW 2795
Ethics committee country [1] 297757 0
Australia
Date submitted for ethics approval [1] 297757 0
17/05/2017
Approval date [1] 297757 0
11/07/2017
Ethics approval number [1] 297757 0
H17101

Summary
Brief summary
Lower limb pathology is the most common form of disability among sporting populations, accounting for over 50% of all sporting injuries. Taping is routinely recommended with the expectation it restricts joint range of motion, and therefore reduces the risk of injury. While the effects of taping have been well investigated in the literature, gaps still exist around the effect of ankle strapping on knee function, and whether ankle movement increases as strapping tape fatigues.

Gaining a better understanding of the relationship ankle strapping has with knee function, and whether fatigued strapping tape has the ability to limit ankle range of motion. As the current research has many limitations and inconsistencies, the findings may enable better decision making by practitioners looking to prevent lower limb injuries.

This study has been developed with two aims: 1) To inform athletes, and those working with athletes, about the impact of tape fatigue on tapes role as an injury prevention method, and 2) To inform athletes, and those working with athletes, about the impact of ankle tape on knee mechanics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75022 0
Mr Luke Donnan
Address 75022 0
Charles Sturt University
PO Box 789
Albury NSW 2640
Country 75022 0
Australia
Phone 75022 0
+61260519258
Fax 75022 0
Email 75022 0
ldonnan@csu.edu.au
Contact person for public queries
Name 75023 0
Mr Luke Donnan
Address 75023 0
Charles Sturt University
PO Box 789
Albury NSW 2640
Country 75023 0
Australia
Phone 75023 0
+61260519258
Fax 75023 0
Email 75023 0
ldonnan@csu.edu.au
Contact person for scientific queries
Name 75024 0
Mr Luke Donnan
Address 75024 0
Charles Sturt University
PO Box 789
Albury NSW 2640
Country 75024 0
Australia
Phone 75024 0
+61260519258
Fax 75024 0
Email 75024 0
ldonnan@csu.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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