Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001506482
Ethics application status
Approved
Date submitted
25/10/2016
Date registered
1/11/2016
Date last updated
7/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Kinesio tape colour on lower limb performance
Scientific title
Effectiveness of different colours of kinesio tape on lower limb performance in healthy adults – a randomised controlled, crossover trial
Secondary ID [1] 290375 0
None
Universal Trial Number (UTN)
U1111-1188-9937
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb performance 300685 0
Condition category
Condition code
Musculoskeletal 300532 300532 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive three different interventions in random order: (1) application of red Kinesio tape; (2) application of blue Kinesio tape; and (3) application of beige (skin colour) Kinesio tape.
Kinesio tape will be applied by a registered physiotherapist to the rectus femoris, vastus lateralis, and vastus medialis muscles of the dominant limb, in longitudinal strips from proximal to distal. The tape will be applied with 50% tension on the middle of the strip, and no tension on the ends. The rectus femoris tape will extend from 10 cm below the anterior superior iliac spine to the superior boarder of the patella. Tape applied to the vastus lateralis will extend from the greater trochanter to the lateral boarder of the patella, while the vastus medialis tape will extend from the middle third of this muscle to the medial boarder of the patella. Tape will be applied while the participant is standing on the foot of the non-taped leg, with the hip of the taped limb in neutral positioning and the knee flexed to 90 degrees. The tape will be kept for the duration of the assessment (about 20 minutes). Once the first assessment is completed, participants will be given at least 5 minutes to rest and will need to rate “No exertion at all” on the Borg Rating of Perceived Exertion (RPE) scale before the new assessment commences.
Intervention code [1] 296205 0
Treatment: Other
Comparator / control treatment
Participants will undergo assessment on two different control conditions, allocated in random order: (1) application of beige (skin colour) Kinesio tape without tension, which will be a sham intervention; and (2) no tape.
The application of the beige Kinesio tape will follow the same procedures however no tension will be added on application.
Control group
Placebo

Outcomes
Primary outcome [1] 299954 0
Distance (in cm) achieved on horizontal jumps (best distance of three attempts).
Timepoint [1] 299954 0
Immediate following each tape application (and after control condition - i.e., no tape).
Secondary outcome [1] 328642 0
Knee extensor torque assessed with with an isokinetic dynamometer.
Timepoint [1] 328642 0
Immediate following each tape application (and after control condition - i.e., no tape).
Secondary outcome [2] 328697 0
Neuromuscular function (number of motor evoqued potentials using Transcranial Magnetic Stimulation).
Timepoint [2] 328697 0
Immediate following each tape application (and after control condition - i.e., no tape).

Eligibility
Key inclusion criteria
1. Healthy individuals aged between 18 and 40 years;
2. Provide written informed consent.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they present with any of the following:
1. Lower limb osteoarthritis or rheumatoid arthritis;
2. Low back pain and/or referred/radicular pain to the lower limb in the previous 12 months;
3. Sensory disturbances;
4. History of ankle or knee instability;
5. History of osteomyoarticular lesion or surgery in the lower limb over the last 12 months;
6. Non-corrected neurological, vestibular, visual or hearing impairments;
7. Allergy to adhesive material;
8. Individuals who experience pain during collection procedures, or those who are unable to receive the interventions as per protocol..

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be concealed using opaque envelops and conducted by an independent person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
One-way repeated measures analyses of covariance (ANCOVAs) will be used to compare the differences in change scores from baseline for each condition. Between-group comparisons will use the independent t-test with a significance level of 5%. An intention-to-treat principle will be used for data analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2016
Actual
26/10/2016
Date of last participant enrolment
Anticipated
25/11/2016
Actual
16/12/2016
Date of last data collection
Anticipated
25/11/2016
Actual
16/12/2016
Sample size
Target
32
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14526 0
2904 - Macarthur

Funding & Sponsors
Funding source category [1] 294772 0
University
Name [1] 294772 0
Early Career Research Grant from the School of Science and Health, Western Sydney University
Country [1] 294772 0
Australia
Primary sponsor type
University
Name
School of Science and Health, Western Sydney University
Address
Campbelltown Campus
Narellan Road & Gilchrist Drive
Macarthur NSW 2904
Country
Australia
Secondary sponsor category [1] 293618 0
None
Name [1] 293618 0
Address [1] 293618 0
Country [1] 293618 0
Other collaborator category [1] 279272 0
Individual
Name [1] 279272 0
Paula R Beckenkamp
Address [1] 279272 0
The University of Sydney, Discipline of Physiotherapy, Faculty of Health Sciences, 75 East St, Lidcome NSW 2141
Country [1] 279272 0
Australia
Other collaborator category [2] 279273 0
Individual
Name [2] 279273 0
Lucinda Chipchase
Address [2] 279273 0
School of Science and Health, Western Sydney University
Locked Bag 1797,
Penrith, NSW 2751
Country [2] 279273 0
Australia
Other collaborator category [3] 279274 0
Individual
Name [3] 279274 0
Rocco Cavaleri
Address [3] 279274 0
School of Science and Health, Western Sydney University
Locked Bag 1797,
Penrith, NSW 2751
Country [3] 279274 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296178 0
the Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 296178 0
Ethics committee country [1] 296178 0
Australia
Date submitted for ethics approval [1] 296178 0
02/08/2016
Approval date [1] 296178 0
01/09/2016
Ethics approval number [1] 296178 0
H10184

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68998 0
Dr Paula R Beckenkamp
Address 68998 0
The University of Sydney, Discipline of Physiotherapy, Faculty of Health Sciences, 75 East St, Lidcome NSW 2141, Australia
Country 68998 0
Australia
Phone 68998 0
+61 2 9351 9266
Fax 68998 0
Email 68998 0
[email protected]
Contact person for public queries
Name 68999 0
Paula R Beckenkamp
Address 68999 0
The University of Sydney, Discipline of Physiotherapy, Faculty of Health Sciences, 75 East St, Lidcome NSW 2141, Australia
Country 68999 0
Australia
Phone 68999 0
+61 2 9351 9266
Fax 68999 0
Email 68999 0
[email protected]
Contact person for scientific queries
Name 69000 0
Paula R Beckenkamp
Address 69000 0
The University of Sydney, Discipline of Physiotherapy, Faculty of Health Sciences, 75 East St, Lidcome NSW 2141, Australia
Country 69000 0
Australia
Phone 69000 0
+61 2 9351 9266
Fax 69000 0
Email 69000 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
SourceTitleYear of PublicationDOI
EmbaseThe influence of kinesiology tape colour on performance and corticomotor activity in healthy adults: A randomised crossover controlled trial.2018https://dx.doi.org/10.1186/s13102-018-0106-4
N.B. These documents automatically identified may not have been verified by the study sponsor.