Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001043527
Ethics application status
Approved
Date submitted
27/08/2015
Date registered
7/10/2015
Date last updated
7/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Dynamic Tape (trademark) change hip muscle activity and function in healthy females during walking and running?
Scientific title
A comparison of the immediate effects of therapeutic elastic tape, placebo elastic tape and no-tape control on hip muscle recruitment and lower limb kinematics during gait in healthy females
Secondary ID [1] 287324 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb musculoskeletal conditions 295959 0
Condition category
Condition code
Musculoskeletal 296236 296236 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 296239 296239 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will be given an information sheet outlining the requirements for participation in the study. Volunteers will also have the opportunity to ask any questions pertaining to the study and once satisfied will sign a consent form. Participants will then fill in a General Health and Physical Activity questionnaire, and the researcher will record their height, weight, dominant leg and age on this questionnaire.
Participants will be informed that 2 taping conditions will be assessed, without differentiating which tape is the experimental condition and randomly allocated to the order in which they receive the conditions: no tape, experimental tape (Dynamic Tape (trademark)), placebo tape (Dynamic Tape (trademark)), or; no tape, placebo tape, experimental tape.
Surface EMG electrodes will be applied to the self-nominated dominant leg of the participant. EMG will measure the recruitment of gluteus medius, gluteus maximus and tensor fascia latae. Skin preparation and electrode placement protocol will be applied according to internationally recognised guidelines (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM)).
Wireless EMG sensors (Wave PLUS 16 Ch, Commeta Systems, Italy) will be attached to each electrode, with data sampled at 2000 Hz. EMG signals will be adjusted for direct current offset, full wave rectification and filtered with a high pass Butterworth filter with a cut-off of 20 Hz. Each stride will be time normalised to 100 data points and data normalised to the maximum signal magnitude during the running phase of the no-tape condition. For each stride the mean and peak amplitude for stance and swing phase will be obtained.

Assessment 1 - Baseline
A blinded assessor will use 3D motion analysis (Vicon from Oxford Metrics, UK) to assess joint kinematics, applying a ‘cluster model’ outlined by Besier et al. (2003). Retro-reflective markers will be fixed to the participant using double-sided tape and secured using hypoallergenic adhesive tape (Fixomull, Smith & Nephew). Marker locations include; anterior superior iliac spine, posterior superior iliac spine, 3-marker ‘cluster’ on the long axis of the femur and tibia, lateral and medial malleolus, calcaneus, first and fifth metatarsal head.
A static trial will be conducted to ensure the proper functioning of both the EMG electrodes and Vicon markers. The participant will then walk on the treadmill at a self-selected pace for 5 minutes to warm up.
To assess muscle recruitment and joint kinematics, the participant will walk on a treadmill at a self-selected pace for 3 minutes, where EMG and Vicon measures will be recorded continuously from 90 sec - 150 sec. The participant will then increase the treadmill to a self-selected running pace for 3 minutes, where EMG and Vicon measures will be recorded during the same interval. The self-selected walking and running paces will be recorded and used for all further treadmill assessments.
At the conclusion of baseline assessments, the first taping condition will be applied. To minimise error, EMG electrodes and Vicon markers will remain in situ throughout the trial.

Assessment 2. Taping condition 1 or 2
Taping condition: Experimental tape– Two parallel double-layered lengths of 7.5cm width elastic tape (Dynamic Tape (trademark)) will be applied as a spiral technique to the hip and thigh with the participant positioned (standing) in maximal combined hip extension, abduction and external rotation. The tape will commence on the anteromedial aspect of the distal thigh approximately 10cm above the medial joint line of the knee. It will extend superiorly in a posterolateral direction, and travel behind the mid thigh to surface on the anteromedial aspect of the proximal thigh. As the tape continues in a proximal direction it will pass inferior and posterior to the greater trochanter and finish on the iliac crest of the contralateral limb. As per the manufacturer’s recommendations, an anchor point of > 4 inches proximally and distally will have no tension applied to the tape (to minimise skin irritation) while the rest of the tape’s length will be stretched to the onset of its resistance only.
Participants will be given warnings regarding the potential for skin reactions to tape. In addition their skin will be monitored by the researchers throughout the test procedure and the tape will be immediately removed if any adverse effects are demonstrated. Following application of the tape the walking and running assessments will be repeated following the protocol that was used for the baseline assessments. The participants’ previously selected pace for the walk and run will be used during this assessment.
At the completion of the running phase, participants will have the taping condition removed and perform a washout walk (90 sec) and run (90 sec), with Vicon and EMG recordings taken continuously from (15 sec - 75 sec) during both walk and run phases.

Assessment 3. Taping condition 2 or 1
Taping condition: Placebo tape – The placebo taping technique is identical to the experimental taping technique except that the tape will be applied with no stretch and in neutral standing position in order to minimise its biomechanical influence during gait.
Following application of the second taping condition the walking and running assessments will be repeated following the protocol that was used for the baseline assessments.
All tape applications and test sessions will be supervised by a physiotherapist and/or exercise physiologist/biomechanist trained in the use of the techniques and equipment.
Intervention code [1] 292642 0
Treatment: Devices
Intervention code [2] 292644 0
Prevention
Intervention code [3] 292752 0
Rehabilitation
Comparator / control treatment
Assessment 1 - Baseline
A blinded assessor will use 3D motion analysis (Vicon from Oxford Metrics, UK) to assess joint kinematics, applying a ‘cluster model’ outlined by Besier et al. (2003). Retro-reflective markers will be fixed to the participant using double-sided tape and secured using hypoallergenic adhesive tape (Fixomull, Smith & Nephew). Marker locations include; anterior superior iliac spine, posterior superior iliac spine, 3-marker ‘cluster’ on the long axis of the femur and tibia, lateral and medial malleolus, calcaneus, first and fifth metatarsal head.

A static trial will be conducted to ensure the proper functioning of both the EMG electrodes and Vicon markers. The participant will then walk on the treadmill at a self-selected pace for 5 minutes to warm up.

To assess muscle recruitment and joint kinematics, the participant will walk on a treadmill at a self-selected pace for 3 minutes, where EMG and Vicon measures will be recorded from 90 sec - 150 sec. The participant will then increase the treadmill to a self-selected running pace for 3 minutes, where EMG and Vicon measures will be recorded during the same interval. The self-selected walking and running paces will be recorded and used for all further treadmill assessments.

At the conclusion of baseline assessments, the first taping condition will be applied. To minimise error, EMG electrodes and Vicon markers will remain in situ throughout the trial.

As stated above, a placebo tape will also be used in this study as a comparator. The placebo taping technique is identical to the experimental taping technique except that the tape will be applied with no stretch and in neutral standing position to minimise its biomechanical influence during gait.
Control group
Active

Outcomes
Primary outcome [1] 295900 0
Changes in lower limb kinematics (measured using 3D motion analysis (Vicon from Oxford Metrics, UK) at the hip (hip flexion/extension, abduction/adduction and internal/external rotation); knee (flexion/extension, valgus/varus, tibial internal/external rotation); and foot/ankle (plantar/dorsiflexion, inversion/eversion, adduction/abduction)
Timepoint [1] 295900 0
To assess joint kinematics for the baseline and taping conditions, the participant will walk on a treadmill at a self-selected pace for 3 minutes, where Vicon measures will be recorded continuously from 90 sec - 150 sec. The participant will then increase the treadmill to a self-selected running pace for 3 minutes, where Vicon measures will be recorded during the same interval.
At the completion of both the first and the second taping condition, participants will have the taping condition removed and perform a washout walk (90 sec) and run (90 sec), with Vicon recordings taken continuously from 15 sec - 75sec during both walk and run phases.
Secondary outcome [1] 316887 0
Changes in recruitment of the gluteus maximus muscle
This will be measured using surface EMG (Wave PLUS 16 Ch, Commeta Systems, Italy) and expressed as a percentage of MVC as determined from the maximal EMG signal during the no tape control.
EMG signals will be sampled at 2000Hz, adjusted for direct current offset, full wave rectification and filtered with a high pass Butterworth filter with a cut-off of 20 Hz. Each stride will be time normalised to 100 data points and data normalised to the maximum signal magnitude during the running phase of the no-tape condition. For each stride the mean and peak amplitude for stance and swing phase will be obtained.
Timepoint [1] 316887 0
To assess muscle recruitment for the baseline and taping conditions, the participant will walk on a treadmill at a self-selected pace for 3 minutes, where EMG will be recorded continuously from 90 sec - 150 sec. The participant will then increase the treadmill to a self-selected running pace for 3 minutes, where EMG will be recorded during the same interval.
At the completion of both the first and the second taping condition, participants will have the taping condition removed and perform a washout walk (90 sec) and run (90 sec), with EMG recordings taken continuously from 15 sec-75 sec during both walk and run phases.
Secondary outcome [2] 317236 0
Changes in recruitment of the gluteus medius muscle
This will be measured using surface EMG (Wave PLUS 16 Ch, Commeta Systems, Italy) and expressed as a percentage of MVC as determined from the maximal EMG signal during the no tape control.
EMG signals will be sampled at 2000Hz, adjusted for direct current offset, full wave rectification and filtered with a high pass Butterworth filter with a cut-off of 20 Hz. Each stride will be time normalised to 100 data points and data normalised to the maximum signal magnitude during the running phase of the no-tape condition. For each stride the mean and peak amplitude for stance and swing phase will be obtained.
Timepoint [2] 317236 0
To assess muscle recruitment for the baseline and taping conditions, the participant will walk on a treadmill at a self-selected pace for 3 minutes, where EMG will be recorded continuously from 90 sec - 150 sec. The participant will then increase the treadmill to a self-selected running pace for 3 minutes, where EMG will be recorded during the same interval.
At the completion of both the first and the second taping condition, participants will have the taping condition removed and perform a washout walk (90 sec) and run (90 sec), with EMG recordings taken continuously from 15 sec-75 sec during both walk and run phases.
Secondary outcome [3] 317237 0
Changes in recruitment of the tensor fascia lata muscle
This will be measured using surface EMG (Wave PLUS 16 Ch, Commeta Systems, Italy) and expressed as a percentage of MVC as determined from the maximal EMG signal during the no tape control.
EMG signals will be sampled at 2000Hz, adjusted for direct current offset, full wave rectification and filtered with a high pass Butterworth filter with a cut-off of 20 Hz. Each stride will be time normalised to 100 data points and data normalised to the maximum signal magnitude during the running phase of the no-tape condition. For each stride the mean and peak amplitude for stance and swing phase will be obtained.
Timepoint [3] 317237 0
To assess muscle recruitment for the baseline and taping conditions, the participant will walk on a treadmill at a self-selected pace for 3 minutes, where EMG will be recorded continuously from 90 sec - 150 sec. The participant will then increase the treadmill to a self-selected running pace for 3 minutes, where EMG will be recorded during the same interval.
At the completion of both the first and the second taping condition, participants will have the taping condition removed and perform a washout walk (90 sec) and run (90 sec), with EMG recordings taken continuously from 15 sec-75 sec during both walk and run phases.

Eligibility
Key inclusion criteria
Female
18 years of age or older
Of good general health
Willing to participate in the current trial
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Major lower limb or spinal surgery in the last 12 months (may affect their ability to complete the physical aspects of the trial)
Lower limb or spinal musculoskeletal injury within the last 6 months (may restrict their ability to complete the physical aspects of the trial)
Pain aggravated by walking or running (the components of the study may exacerbate their symptoms)
Known cardiovascular or neurological conditions (participating in this study may place undue stress on these body systems)
Known allergy to tape (application of the intervention may trigger this allergy)

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)
Female volunteers will be recruited from a convenience sample of staff and students at Australian Catholic University, Sydney. Flyers containing information about the study will be placed around ACU campuses asking interested persons fitting the inclusion criteria (healthy females > 18 years of age) to contact the researchers by phone or email for more information about the study.
Once initial contact is made, potential volunteers will be screened by telephone as to their eligibility for inclusion in the study and a time agreed upon for them to participate in the trial. Eligible volunteers will be provided with an information sheet thoroughly explaining the study and informed written consent to participate in the study will be obtained before the test session commences
Once enrolled in the study the participant will be assigned a pre-allocated number generated by a computer randomisation program denoting the sequence in which they will receive the two conditions. Being a crossover design all participants will receive all conditions however they will not be informed which taping technique is the experimental condition. The physiotherapist applying the taping techniques will have access to the allocation schedule however allocation will be concealed from the outcome assessor at all times.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation program will be used to randomise the participants into the two conditions. Condition 1 will have the placebo tape assessed first, followed by Dynamic Tape (trademark). Condition 2 will have Dynamic Tape (trademark) assessed first, followed by the placebo tape. An unblinded researcher will have access to the group allocation for each participant, and will be responsible for the application and removal of each tape throughout the trial. This researcher will conduct the initial briefing, but will have no role in participant assessment or analysis of results. The participant will be informed that the study is analysing the effects of 2 different types of tapes, without differentiating which tape will be the experimental condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations indicate that 18 participants will be sufficient to detect a 10 degree change in range or motion which is considered to be clinically significant, based on a standard deviation of 10 degrees, power of 0.80 and alpha level 0.05
Data processing and data entry will be performed by a research assessor who is blinded to group allocation. Statistical analyses will be performed using SPSS (trademark)software. A within subject comparison will be performed using a repeated measures ANOVA to identify significant change in hip, knee and foot/ankle ranges of motion. Age, weight and height will be included as covariates and the alpha level will be set at 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2015
Actual
3/06/2015
Date of last participant enrolment
Anticipated
23/10/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 10198 0
2060 - North Sydney
Recruitment postcode(s) [2] 10199 0
2135 - Strathfield

Funding & Sponsors
Funding source category [1] 291887 0
Self funded/Unfunded
Name [1] 291887 0
Country [1] 291887 0
Primary sponsor type
Individual
Name
Ms Sonia Coates
Address
School of Physiotherapy, Australian Catholic University
Level 9, 33 Berry Street
North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 290552 0
Individual
Name [1] 290552 0
Dr Mark Moresi
Address [1] 290552 0
School of Exercise Science, Australian Catholic University
Level 2-C2.23 Edward Clancy Building
25A Barker Road
Strathfield NSW 2135
Country [1] 290552 0
Australia
Other collaborator category [1] 278594 0
Individual
Name [1] 278594 0
Dr Melinda Smith
Address [1] 278594 0
Centre for Musculoskeletal Research
Mary MacKillop Institute for Health Research
Australian Catholic University
631 Stanley Street, Woolloongabba QLD 4102
Country [1] 278594 0
Australia
Other collaborator category [2] 278595 0
Individual
Name [2] 278595 0
Ms Ashleigh Graves
Address [2] 278595 0
School of Physiotherapy
Australian Catholic University
Level 9, 33 Berry Street
North Sydney NSW 2060
Country [2] 278595 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293394 0
ACU Human Research Ethics Committee
Ethics committee address [1] 293394 0
Ethics committee country [1] 293394 0
Australia
Date submitted for ethics approval [1] 293394 0
19/12/2014
Approval date [1] 293394 0
22/05/2015
Ethics approval number [1] 293394 0
2014 352N

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

Contacts
Principal investigator
Name 59698 0
Ms Sonia Coates
Address 59698 0
School of Physiotherapy
Australian Catholic University
Level 9, 33 Berry Street
North Sydney NSW 2060
Country 59698 0
Australia
Phone 59698 0
+61 2 97392278
Fax 59698 0
Email 59698 0
sonia.coates@acu.edu.au
Contact person for public queries
Name 59699 0
Sonia Coates
Address 59699 0
School of Physiotherapy
Australian Catholic University
Level 9, 33 Berry Street
North Sydney NSW 2060
Country 59699 0
Australia
Phone 59699 0
+61 2 97392278
Fax 59699 0
Email 59699 0
sonia.coates@acu.edu.au
Contact person for scientific queries
Name 59700 0
Sonia Coates
Address 59700 0
School of Physiotherapy
Australian Catholic University
Level 9, 33 Berry Street
North Sydney NSW 2060
Country 59700 0
Australia
Phone 59700 0
+61 2 97392278
Fax 59700 0
Email 59700 0
sonia.coates@acu.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23388Other https://transform.physio/wp-content/uploads/2019/09/Abstract_Book_Adelaide_2019.pdf sonia.coates@acu.edu.au
23823Other    Honours thesis available on request by emailing th... [More Details]

Results publications and other study-related documents

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