Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001204639
Ethics application status
Approved
Date submitted
17/10/2014
Date registered
17/11/2014
Date last updated
17/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of kinesio taping on skill-related physical fitness and muscle activity following neuromuscular fatigue: A randomized-controlled trial
Scientific title
Effects of kinesio taping, versus no taping on skill-related physical fitness and muscle activity following neuromuscular fatigue in male recreational athletes: A randomized-controlled trial
Secondary ID [1] 285110 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromuscular fatigue 292666 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292981 292981 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kinesio taping will be used in this study. A physiotherapist that is specifically trained to apply kinesio taping for the purpose of this study. The type of kinesio tape that will be used is Kinesio Tex Gold with size of 5 cm and beige in colour. The tape will be applied to 3 muscles (rectus femoris of quadriceps, biceps femoris of hamstring and medial gastrocnemius) of the dominant leg of the participants. The tape will be applied during participants preparation atleast 30 minutes prior warm up and stretching at the High Performance Gym (study setting). Once the tape is applied, the tape will be used throughout the study (approximately 2 hours) as the tape is effective for 3-5 days. No replacement of tape will be required. Tape is applied to each participant on a single occasion only. The tape applied will be regularly checked throughout the study. If the edge of tape begun to lift, it will be trimmed. If the tape applied come off, new tape will be applied.

After the warm up and stretching session, participants will be given a session to get familiarize with the test and protocol before the actual procedure. Then, participants will be asked to set a preferred jogging speed for dynamic postural control measurement. This will be achieved by participants jog on the treadmill with a fixed speed of 0.5 km/h to start. Next, the belt speed will be increased by 0.4 km/h every 15 seconds until participant found the preferred speed.

Next, participant will do the actual testing procedure.
For the baseline test or pre-test, prior starting, participant’s maximum vertical jump will be recorded. Participant then will perform the T-Drill Test to assess the agility. After completing T-Drill Test, participant then will perform vertical jump test to assess leg power. Next, subject will perform Star Excursion Balance Test (SEBT) to assess balance. Next, subject will step on the treadmill to perform assessment of dynamic postural control. The washout period in between test will be 2-3 minutes. The test will be in a random order for each and every participant. The same procedure will be repeated for post test.

To induce neuromuscular fatigue, modified Functional Agility Short Term Fatigue Protocol (FAST-FP) will be used. This protocol consist of vertical jumping, stepping up and down, squatting and L-Drill. Firstly, participants will perform three consecutive vertical jump. Secondly, participants will perform a series of step up and down a 30 cm box for 20 seconds at 220 beats per minute (bpm). Thirdly, subjects will perform squatting to 90 degree knee flexion for 3 times. Finally, participants will perform a L-Drill (proagility shuttle run). For L-Drill, three cones will be set in the shape of an L with 4.05 meter apart. Participants will start at starting cone, sprint to the first cone and sprint back to the starting cone. Then participants will sprint to first cone, ran around it and cut inside to the second cone. Participants will ran in a circle around the second cone from the inside to the outside and sprint around the first cone before running to the starting cone. Completing the four tasks (vertical jumps, step-up and down, squatting and L-drill) will be counted as one set of the protocol. This will be repeated until maximal neuromuscular fatigue is achieved. Fatigue criteria will be manifested by the participants did not achieve 90% of the maximal jump on all 3 vertical jumps for 2 consecutive fatigue sets.

After maximal neuromuscular fatigue is achieved, participants will be test for post-test including T-Drill Test, vertical jump test, Star Excursion Balance Test (SEBT) and postural control test on treadmill in random order. After completing one test, participant will be asked to perform again the fatigue protocol to ensure the maximal neuromuscular fatigue level is maintained. To minimize the recovery of neuromuscular fatigue, the manifestation of fatigue and the data collection will be less than 10-15 seconds.

There will be four groups. For Group A, tape will be applied to the participants and they will be exposed to neuromuscular fatigue. For Group B, no tape will be applied but participant will be exposed to neuromuscular fatigue. For Group C, tape will be applied but participant will not be exposed to neuromuscular fatigue. For Group D, no tape will be applied and participant will not be exposed to neuromuscular fatigue. For Group C and Group D where participants will not be exposed to neuromuscular fatigue, after completing the baseline test, participants will be given 15 minutes rest as washout period before proceeding to post-test.
Intervention code [1] 289960 0
Prevention
Comparator / control treatment
No taping
Control group
Active

Outcomes
Primary outcome [1] 292837 0
Composition score of Star Excursion Balance Test (SEBT)
Timepoint [1] 292837 0
Baseline and post test. Baseline assessment is conducted after the tape is applied. Post test is within 15 seconds after manifestation neuromuscular fatigue
Secondary outcome [1] 309778 0
Height of Vertical Jump Test
Timepoint [1] 309778 0
Baseline and post test. Baseline assessment is conducted after the tape is applied. Post test is within 15 seconds after manifestation neuromuscular fatigue
Secondary outcome [2] 309779 0
Time taken to complete T-Drill Test
Timepoint [2] 309779 0
Baseline and post test. Baseline assessment is conducted after the tape is applied. Post test is within 15 seconds after manifestation neuromuscular fatigue
Secondary outcome [3] 309780 0
Parameters of Postural control. The postural control during running will be assessed using a pressure sensitive treadmill (Zebris FDM-T Treadmill System 'Registered Trademark', Isny, Germany). The treadmill will present a continuous trace of the Center of Pressure (CoP) trajectory for jogging/dynamic postural control. This is term as “butterfly”. This will provide the information on anterior/posterior variability, lateral symmetry and lateral variability.
Timepoint [3] 309780 0
Baseline and post test. Baseline assessment is conducted after the tape is applied. Post test is within 15 seconds after manifestation neuromuscular fatigue
Secondary outcome [4] 309781 0
Muscle activity will be assessed using electromyography (EMG) during performing skill related physical fitness tests such as Star Excursion Balance Test (SEBT) for balance, T-Drill Test for agility and using pressure sensitive treadmill for postural control.
Timepoint [4] 309781 0
Baseline and post test. Baseline assessment is conducted after the tape is applied. Post test is within 15 seconds after manifestation neuromuscular fatigue

Eligibility
Key inclusion criteria
1.Male
2.Recreational athletes
Minimum age
18 Years
Maximum age
25 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.History of sport injury to the lower limb

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)
Subjects will be randomly assigned to one of the four groups using sequently numbered sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization will be generated using sequentially numbered, opaque, sealed envelopes. Each envelope contains a carbon paper and a paper with one of four group code label. After the envelope is sealed, the envelopes will be shuffled. Then only the envelope will only be sequentially numbered (1,2,3...100). Each participant will be given the envelope number-sequentially from 1 to 100. Participants’ information will be written on the envelopes prior to opening of the envelope. Audit trail will served with transferring the information to the assignment paper by the carbon paper.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation

The sample size is calculated using GPower 3.1 software. The statistical power will be set at 95% while effect size at 0.25 and p<0.05. Ratio for every group is 1:1:1:1.

Analysis

Data will be analyzed using Statistical Package for Social Science (SPSS) version 20. Level of significant differences will be set at p < 0.05. Descriptive statistics will be performed on demographic data and will be reported as means (M) +/- standard deviations (SD), range (minimum-maximum), median, frequency (%). Paired t-test will be performed to compare means between the dependent variables. ANOVA will be used to compare the means of groups in order to determine whether a significant difference exist between the groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/06/2014
Actual
2/06/2014
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6276 0
Malaysia
State/province [1] 6276 0
Selangor

Funding & Sponsors
Funding source category [1] 289718 0
University
Name [1] 289718 0
Universiti Teknologi MARA
Country [1] 289718 0
Malaysia
Primary sponsor type
Individual
Name
Muhamad Noh Zulfikri Mohd Jamali
Address
Universiti Teknologi MARA,
Puncak Alam Campus,
42300 Bandar Puncak Alam,
Selangor
Country
Malaysia
Secondary sponsor category [1] 288411 0
Individual
Name [1] 288411 0
Dr. Maria Justine
Address [1] 288411 0
Universiti Teknologi MARA,
Puncak Alam Campus,
42300 Bandar Puncak Alam,
Selangor
Country [1] 288411 0
Malaysia
Secondary sponsor category [2] 288412 0
Individual
Name [2] 288412 0
Saiful Adli Bukry
Address [2] 288412 0
Universiti Teknologi MARA,
Puncak Alam Campus,
42300 Bandar Puncak Alam,
Selangor
Country [2] 288412 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291455 0
Research Ethic Comittee, Faculty of Health Sciences, UiTM
Ethics committee address [1] 291455 0
Ethics committee country [1] 291455 0
Malaysia
Date submitted for ethics approval [1] 291455 0
Approval date [1] 291455 0
14/03/2014
Ethics approval number [1] 291455 0

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

Contacts
Principal investigator
Name 50482 0
Dr Maria Justine
Address 50482 0
Universiti Teknologi MARA,
Puncak Alam Campus,
42300 Bandar Puncak Alam,
Selangor
Country 50482 0
Malaysia
Phone 50482 0
+60332584524
Fax 50482 0
Email 50482 0
[email protected]
Contact person for public queries
Name 50483 0
Maria Justine
Address 50483 0
Universiti Teknologi MARA,
Puncak Alam Campus,
42300 Bandar Puncak Alam,
Selangor
Country 50483 0
Malaysia
Phone 50483 0
+60332584524
Fax 50483 0
Email 50483 0
[email protected]
Contact person for scientific queries
Name 50484 0
Maria Justine
Address 50484 0
Universiti Teknologi MARA,
Puncak Alam Campus,
42300 Bandar Puncak Alam,
Selangor
Country 50484 0
Malaysia
Phone 50484 0
+60332584524
Fax 50484 0
Email 50484 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
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