Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000826448
Ethics application status
Approved
Date submitted
20/06/2016
Date registered
23/06/2016
Date last updated
14/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of Q-angle, proprioception and kinesiology tape on lower limb landing biomechanics.
Scientific title
The influence of kinesiology tape on proprioceptive function and muscle activity in healthy adults
Secondary ID [1] 289498 0
Nil known
Universal Trial Number (UTN)
U1111-1184-4621
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb proprioception 299194 0
Condition category
Condition code
Musculoskeletal 299203 299203 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The testing involved in this project will occur across two separate sessions, one week apart. Each session will be conducted in the Charles Sturt University (Albury) Gait Lab, and will take approximately 30 minutes. The one week between testing sessions will serve as the wash-out period. The testing sessions will involve one participant at a time.

Prior to attending the first 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 be reviewed on arrival to ensure the potential participant is safe to complete testing. All testing will be carried out by three honours students and one supervisor. The honours students are third year students in the Podiatry (x 2) and Physiotherapy (x 1) undergraduate courses. All students have current first aid training. The supervisor has both Human Movement and Podiatry qualifications, and has over 10 years clinical experience.

Prior to preparing the participant they will be allocated to either the kinesiology tape group, or the sham taping group for the first testing session. They will be testing with the alternate taping method at the subsequent testing session. The kinesiology tape will be applied under no tension, which is consistent with the recommendations presented in the manufacturers literature "PowerTaping - version 3.2'. The tape will be applied to the site of the muscle belly of the tibialis anterior, rectus femoris and biceps femoris. The location of the tape will also be in accordance with the recommendation provided in the manufacturers literature. The sham tape will be applied in exactly the same location and fashion described by the kinesiology tape manufacturer, however rigid tape will be applied as opposed to kinesiology tape.

The participant preparation will involve application of 30 reflective markers for 3D motion analysis, and EMG sensors to assess muscle activity. Both will be adhered with double sided tape. The application of strapping tape will be completed by either the student or the supervisor, all of whom have training in the application of strapping tape (both rigid tape and kinesiology tape).

The intensity of the activity being completed during testing would be best described as low-moderate intensity. The testing session will begin with five minutes of walking at a comfortable speed on a treadmill. The participant will be asked to complete a joint re-position test five times, and the star excursion balance test three times. This will be completed on a force plate, and with 3D motion analysis. The dynamic tests will include a hop test (takeoff and landing both on the non-dominant leg, and hopping from a distance 40% of the participants height), and a maximal vertical jump test. Each of the dynamic tests will be completed five times. These will also be completed on a force plate, and with 3D motion analysis.
Intervention code [1] 295086 0
Treatment: Other
Comparator / control treatment
The participants will work as their own controls in this project. The protocols for both taping methods will be the same as described in the 'Description of Intervention' section. The sham tape (rigid tape) will be applied in exactly the same fashion as the kinesiology tape to a specific muscule site (the muscle belly of the tibialis anterior, rectus femoris and biceps femoris). This will enable us to consider if the effects of kinesiology tape are due to the tapes properties, or is simply due to something being adhered to the site.

The sham taping technique will be applied for the duration of the testing session (approximately 30 minutes), which is the same duration the kinesiology tape will be applied for. The sham tape will be applied by one of the three honours students or the supervisor, all of whom have training in the application of strapping tape.
Control group
Placebo

Outcomes
Primary outcome [1] 298683 0
The primary outcome will be the impact of kinesiology tape on proprioceptive function.

The tests being completed will be the repeat joint position test, and the star excursion balance test. The use of the force plate and 3D motion analysis will allow analysis of changes in center of pressure and movement of particular markers. The use of Electromyographical (EMG) assessment will also allow for monitoring of muscle activity during the balance activities.
Timepoint [1] 298683 0
This will be assessed using one taping method (either kinesiology tape or sham) at the initial testing session, and the alternate taping method one week later.
Secondary outcome [1] 324953 0
The secondary outcome will be the impact of kinesiology tape on muscle activity.

The tests being completed will be the hop test, and the vertical leap test. The use of the force plate and 3D motion analysis will allow analysis of downward pressure and movement of particular markers. The use of Electromyographical (EMG) assessment will also allow for monitoring of muscle activity during the dynamic activities.
Timepoint [1] 324953 0
This will be assessed using one taping method (either kinesiology tape or sham) at the initial testing session, and the alternate taping method one week later.

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)
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 study will be aiming to recruit 36 participants. G*Power was used to complete the sample size calculations. Given that we will be comparing the individual against themselves ‘Means: Difference between two dependent means (matched pairs)’ was chosen as the statistical test. As a standard allocation in this type of study, assuming a medium effect size, 0.5 was chosen. 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. The originally intent was to aim for a power of 80%, which required a sample of 27, This would equate to each student recruiting nine participants. It is seen as a reasonable expectation that each student could recruit 12 participants, which would mean a sample size of 36, and fit with a power of 90%,


Means and standard deviations will be calculated for all variables. Means of each variable will be used to distinguish if there are any differences in movement patterns between factors. Repeated measures analyses of variance (ANOVA) will be used to determine whether differences exist between the means and standard deviations of all outcome variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2016
Actual
27/07/2016
Date of last participant enrolment
Anticipated
18/07/2017
Actual
29/09/2016
Date of last data collection
Anticipated
Actual
7/10/2016
Sample size
Target
36
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13423 0
2640 - Thurgoona

Funding & Sponsors
Funding source category [1] 293869 0
University
Name [1] 293869 0
Charles Sturt University
Country [1] 293869 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
PO Box 789
Albury NSW 2640
Country
Australia
Secondary sponsor category [1] 292696 0
None
Name [1] 292696 0
Address [1] 292696 0
Country [1] 292696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295289 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 295289 0
Human Research Ethics Committee
Office of Academic Governance
Charles Sturt University
Panorama Avenue
Bathurst NSW 2795
Ethics committee country [1] 295289 0
Australia
Date submitted for ethics approval [1] 295289 0
17/06/2016
Approval date [1] 295289 0
21/07/2016
Ethics approval number [1] 295289 0
H16113

Summary
Brief summary
Lower limb pathology is the most common form of disability among sporting populations,
accounting for over 50% of all sporting injuries. Kinesiology tape has been marketed as a means of altering muscle activity and improving proprioceptive function, however the research that currently exists around the ability of kinesiology tape to achieve these outcomes is both limited and inconsistent.

This study has been developed with two aims. 1) Investigate the relationship between kinesiology tape and muscle activity during a dynamic task, and 2) Investigate the relationship between kinesiology tape and dynamic proprioception. The results of this study will therefore have implications for those currently using kinesiology tape to alter proprioception and muscle activity.

This study will be experimental, using a cross-over design. The participants will be randomly assigned to either an intervention or a sham group initially, performing a series of movement tasks with either kinesiology tape or a sham tape applied. Following a wash-out period, each participant will then cross-over and complete the same movement tasks using the alternate taping intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66786 0
Mr Luke Donnan
Address 66786 0
Charles Sturt University
PO Box 789
Albury NSW 2640
Country 66786 0
Australia
Phone 66786 0
+61260519258
Fax 66786 0
Email 66786 0
[email protected]
Contact person for public queries
Name 66787 0
Mr Luke Donnan
Address 66787 0
Charles Sturt University
PO Box 789
Albury NSW 2640
Country 66787 0
Australia
Phone 66787 0
+61260519258
Fax 66787 0
Email 66787 0
[email protected]
Contact person for scientific queries
Name 66788 0
Mr Luke Donnan
Address 66788 0
Charles Sturt University
PO Box 789
Albury NSW 2640
Country 66788 0
Australia
Phone 66788 0
+61260519258
Fax 66788 0
Email 66788 0
[email protected]

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

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

Documents added automatically
No additional documents have been identified.