Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001272785
Ethics application status
Approved
Date submitted
15/11/2013
Date registered
19/11/2013
Date last updated
19/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kinesiology Taping on muscle performance of quadriceps femoris.
Scientific title
Influence of Kinesiology Taping on muscle flexibility and bioelectrical activity of quadriceps femoris: a randomized, placebo controlled pilot study in healthy volleyball players.
Secondary ID [1] 283603 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
muscle performance in healthy athletes 290525 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290915 290915 0 0
Physiotherapy
Musculoskeletal 290916 290916 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study was to assess the effect of kinesiology taping (KT) on surface electromyographic (sEMG) activity and muscle flexibility of rectus femoris (RF), vastus lateralis (VL) and vastus medialis (VM) muscles in healthy volleyball players.

Active KT intervention:
In subjects from KT group, the one-time Kinesio Tape (Nitto Denko K-Active Tape 5m/5cm, Japan) over the RF in an Y shape was used to increase muscle strength (facilitation technique). The subjects were in a supine position, with knee joint passively flexed out of the bed at an angle of 90 degrees. The KT was applied longitudinally in descending direction, from RF origin (anterior inferior iliac spine) to its insertion (tibial tuberosity). The basis of KT was applied from 2 – 3 cm below RF origin without tension. The middle part of KT between origin and patella basis was applied without tension but during RF muscle passively stretching at flexed knee joint position. Finally two tails were circled around the patella and placed on the skin without tension at an angle of 90 degrees flexed knee joint position. In KT group intervention involved left RF (n=7) and right RF (n=5) and time of application was continued for 24 hours.

Passive PT intervention:
In subjects form PT group, the one-time adhesive non-elastic tape (Polovis Plus 5m/5cm, Poland) with no therapeutic influence over the same muscle was used. Subjects were in supine position with neutral knee joint position flexed at an angle of 30 degrees. All parts of the PT were applied longitudinally in descending direction in analogous Y shape. In PT group intervention involved left RF (n=5) and right RF (n=5) and time of application was continued for 24 hours. In both groups immediately after 24 hours, KT or PT applications were removed and athletes underwent a final assessment without tapes which was identical to the initial. All procedures were accomplished as one-session intervention in the same conditions (day time, ambient temperature, research room). All subjects were informed not to remove and unstuck the tapes until final measurements will be taken.
Intervention code [1] 288291 0
Rehabilitation
Intervention code [2] 288292 0
Prevention
Intervention code [3] 288308 0
Treatment: Devices
Comparator / control treatment
subjects in control group received a single placebo taping intervention (PT group intervention)
Control group
Placebo

Outcomes
Primary outcome [1] 290903 0
was to registry the resting sEMG activity of vastus lateralis (VL) and vastus medialis (VM) muscles; it was hypothesized that KT application would increase muscle activity in sEMG between initial and final assessment in any of two groups
Timepoint [1] 290903 0
baseline and immediately after removal (at 24 hours) of KT or PT intervention
Primary outcome [2] 290921 0
was to registry the resting and functional sEMG activity of rectus femoris (RF) muscle; it was hypothesized that KT application would increase muscle activity in sEMG between initial and final assessment in any of two groups
Timepoint [2] 290921 0
baseline and immediately after removal (at 24 hours) of KT or PT intervention
Secondary outcome [1] 305572 0
was to analyse the changes in rectus femoris (RF) muscle flexibility showed in Duncan – Ely test (DET); it was hypothesized that KT application would improve muscle flexibility in DET between initial and final assessment in any of two groups
Timepoint [1] 305572 0
baseline and immediately after removal (at 24 hours) of KT or PT intervention

Eligibility
Key inclusion criteria
1. confirmed volleyball participation in Academic Sport Association;
2. lack of chronic nervous or cardiorespiratory diseases;
3. lack of acute and chronic musculoskeletal disorders;
4. lack of knowledge about rules of KT application;
5. good compliance and willingness to sign the written consent form
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. lack confirmed volleyball participation in Academic Sport Association;
2. chronic diseases at present;
3. musculoskeletal disorders at present;
4. lower limb injuries at present;
5. pharmacological treatment at present;
6. recent surgery interventions;
7. confirmed knowledge about rules of KT application;
8. lack of informed consent of the patients

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)
Simple randomisation using a computer-generated
random numbers which were hidden in sequentially numbered envelopes and than selected by subjects. Random allotment contained KT group (W) or placebo group (X) as well as the choice of the left (Y) or right (Z) rectus femoris (RF) muscle for intervention in the same way.
The person responsible for participant allotment was not aware of the designations and therefore, did not know into which group the study participant would be included and which limb would be studied.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by
appropriate website (http://www.random.org/)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
STATISTICA 10 software by StatSoft Company was used for statistical data analysis. Arithmetic means, standard deviations and ranges of variation were calculated for measurable variables. A non – parametric Wilcoxon sequence pair test for dependent variables was used for comparison of results before and after the intervention. Statistical significance was set at p<0.05. A non – parametric U Mann – Whitney test for independent variables (p=0.05) or chi2 test (p=0.05) was used for comparison between groups.

For this pilot analyses included 22 subjects the team had to use non-parametric tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2013
Actual
2/08/2013
Date of last participant enrolment
Anticipated
1/10/2013
Actual
1/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 5633 0
Poland
State/province [1] 5633 0
Opole

Funding & Sponsors
Funding source category [1] 288283 0
University
Name [1] 288283 0
Public Higher Medical Professional School
Country [1] 288283 0
Poland
Primary sponsor type
University
Name
Public Higher Medical Professional School
Address
Katowicka Street 68, 45-060 Opole
Country
Poland
Secondary sponsor category [1] 287001 0
None
Name [1] 287001 0
Address [1] 287001 0
Country [1] 287001 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290177 0
Ethics Committee of Public Higher Medical Professional School
Ethics committee address [1] 290177 0
Ethics committee country [1] 290177 0
Poland
Date submitted for ethics approval [1] 290177 0
01/07/2013
Approval date [1] 290177 0
01/08/2013
Ethics approval number [1] 290177 0

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

Contacts
Principal investigator
Name 44370 0
Dr Tomasz Halski
Address 44370 0
Department of Physiotherapy, Public Higher Professional School, Katowicka Street 68, 45-060 Opole
Country 44370 0
Poland
Phone 44370 0
+48 774 423 524
Fax 44370 0
+48 774 423 525
Email 44370 0
[email protected]
Contact person for public queries
Name 44371 0
Robert Dymarek
Address 44371 0
Department of Nervous System Diseases, University of Medicine in Wroclaw, Bartla Street 5, 51-618 Wroclaw
Country 44371 0
Poland
Phone 44371 0
+48 723 895 770
Fax 44371 0
Email 44371 0
[email protected]
Contact person for scientific queries
Name 44372 0
Robert Dymarek
Address 44372 0
Department of Nervous System Diseases, University of Medicine in Wroclaw, Bartla Street 5, 51-618 Wroclaw
Country 44372 0
Poland
Phone 44372 0
+48 723 895 770
Fax 44372 0
Email 44372 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
EmbaseKinesiology taping does not modify electromyographic activity or muscle flexibility of quadriceps femoris muscle: A randomized, placebo-controlled pilot study in healthy volleyball players.2015https://dx.doi.org/10.12659/MSM.894150
N.B. These documents automatically identified may not have been verified by the study sponsor.