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Trial registered on ANZCTR
Registration number
ACTRN12615000502538
Ethics application status
Approved
Date submitted
24/04/2015
Date registered
20/05/2015
Date last updated
1/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The effectiveness of kinesiology taping for shoulder on pain and motor control in patients after stroke
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Scientific title
The effectiveness of kinesiology taping for shoulder on pain and motor control in patients after stroke
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Secondary ID [1]
286593
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
294888
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Condition category
Condition code
Neurological
295133
295133
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0
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Other neurological disorders
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Stroke
295205
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0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
For the intervention group, kinesiology tape will be applied to the affected shoulder of the participant as clinically required, depending on their presentation which will be assessed by the senior physiotherapist through observation. They will assess for the following features: inferior subluxation, anterior subluxation, internal rotation posturing and scapula elevation with excessive upper trapezius activity at rest. Each of the first three features if found to be present will be separately addressed with a single piece of kinesiology tape, using a vertical, horizontal or rotational technique to cross the shoulder joint. Upper trapezius activity will be addressed with a single piece of tape in an antero-posterior direction across the muscle belly.
The tape will be worn by the participant continuously and will be changed by the senior physiotherapist every three days unless the participant withdraws from the study, or there are signs of skin irritation. Taping will continue for 14 days or until discharge from the ward. With each new application, the participant’s skin integrity will be assessed to determine the appropriateness of continuing. Patients will be monitored for 24 hours by nursing staff and daily by the senior physiotherapist, and among other things, this will monitor the progress of the intervention.
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Intervention code [1]
291710
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Treatment: Other
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Comparator / control treatment
For the placebo group, kinesiology tape will be applied in an ineffective arrangement. Pieces of horizontal tape will be applied below the shoulder joint with appropriate tension however this not cross the shoulder joint. The tape will be worn by the participant continuously and will be changed every three days unless the participant withdraws from the study, or there are signs of skin irritation. With each new application, the participant’s skin integrity will be assessed to determine the appropriateness of continuing.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Pain, assessed using a visual analog scale, and the Ritchie Articular Index.
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Assessment method [1]
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Timepoint [1]
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Fourteen days or discharge from the ward - whichever comes first.
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Secondary outcome [1]
314297
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Range of movement of shoulder external rotation, measured in degrees using a goniometer
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Assessment method [1]
314297
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Timepoint [1]
314297
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Fourteen days or discharge from the ward - whichever comes first.
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Secondary outcome [2]
314298
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Motor recovery, measured using the Chedoke-McMaster impairment assessment inventory.
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Assessment method [2]
314298
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Timepoint [2]
314298
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Fourteen days or discharge from the ward - whichever comes first.
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Secondary outcome [3]
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Range of movement of shoulder flexion, measured in degrees using a goniometer
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Assessment method [3]
314670
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Timepoint [3]
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Fourteen days or discharge from the ward - whichever comes first.
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Secondary outcome [4]
314671
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Range of movement of shoulder abduction, measured in degrees using a goniometer
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Assessment method [4]
314671
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Timepoint [4]
314671
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Fourteen days or discharge from the ward - whichever comes first.
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Eligibility
Key inclusion criteria
Participants will be patients who are newly admitted under neurology with a diagnosis of stroke. The patients will have an upper limb motor impairment as a result of the stroke and on the Chedoke- McMaster Stroke Assessment will be at stage five or less of motor recovery. The patient must also be able to consent to participation in the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will be excluded if they have a known tape allergy, have a previous history of stroke and if they have a pre-existing diagnosis of shoulder pathology on the same side as the upper limb impairment that resulted from the stroke. They will also be excluded if they are receiving palliative care or if they are minors under 18 years of age.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients with a diagnosis of stroke that are admitted to ward G51 will be screened via their patient notes and a routine assessment undertaken by a senior physiotherapist to determine their suitability for the study. If suitable, informed consent will be obtained via writing by the patient. Three senior physiotherapists on the ward will be implementing the taping protocol and collecting data with a senior physiotherapist training two other senior physiotherapists that will be involved in the study on the taping protocol. Data collection for each participant will commence within 24 hours of admission to the ward or on the first working day post admission if admission occurred over a weekend and will continue until patient discharge or day 14, whatever occurs first. Participants will then be randomly allocated into the intervention group or the placebo group via a computer generated random number sequence.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will then be randomly allocated into the intervention group or the placebo group via a computer generated random number sequence.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
Pilot study
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Data will be assessed for normality. Normally distributed data will be analysed using mean and standard deviation. Non parametric data will be analysed using median and interquartile range. Significance will be set at alpha level of 0.05. As this is a pilot study there will be no requirement for sample size calculations.
Comparisons of outcome measures using ordinal scales will be analysed using chi-squared tests, while continuous measures will be analysed using t-tests. Descriptive data will be reported as count and frequency.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/08/2015
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Actual
16/09/2015
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Date of last participant enrolment
Anticipated
10/12/2015
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Actual
25/02/2016
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Date of last data collection
Anticipated
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Actual
18/03/2016
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Sample size
Target
40
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
3731
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
9604
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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N/A
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Address [1]
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N/A
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Country [1]
291159
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Primary sponsor type
Hospital
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Name
Physiotherapy Department, Sir Charles Gairdner Hospital
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Address
Physiotherapy Department
A Block, Sir Charles Gairdner Hospital
Hospital Avenue,
Nedlands, Western Australia, 6009
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
289836
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Country [1]
289836
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sir Charles Gairdner Hospital HREC
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Ethics committee address [1]
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Sir Charles Gairdner Hospital Hospital Avenue Nedlands, Western Australia, 6009
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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28/04/2015
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Approval date [1]
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21/08/2015
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Ethics approval number [1]
292735
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2015-051
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Summary
Brief summary
Loss of motor function and shoulder pain are known outcomes of stroke that affect patients’ well being and independence. Physiotherapy routinely uses a variety of approaches to address these issues, including facilitating improved motor activation and better shoulder alignment. Using rigid strapping tape has been shown to have some benefits as an adjunct to treatment however, more recently kinesiology tape which is more flexible has become readily available. This has been used on many patient and athletic groups, but has only been used once in a group with stroke, and this was not at the shoulder. This study aims to determine if kinesiology tape is useful as part of a treatment approach to managing the affected shoulder in acute stroke. Participants will be recruited from admissions to ward G51 at Sir Charles Gairdner Hospital over a period of 4 months. The study will be a single blinded, randomised controlled trial with the control group receiving placebo taping and the intervention group will receive therapeutic taping. Pain, shoulder position, muscle stiffness and range of movement will be recorded every 3 days during the trial to determine how these factors change over time. Measures of motor impairment in the arm will be taken on admission and discharge (or at 14 days, whichever comes first). It is expected that there will be no adverse effects of the taping. It is anticipated there may be some benefit in using the kinesiology tape for shoulder pain and motor activation, however this problem is multifactorial and the effect size is expected to be low. This study is a pilot study to test the protocol and determine effect size with a view to a more extensive study in the future.
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Trial website
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Trial related presentations / publications
None
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Public notes
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Contacts
Principal investigator
Name
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Ms Liz Bainbridge
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Address
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School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth WA 6845
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Country
56786
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Australia
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Phone
56786
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+61 08 9266 3623
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Fax
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Email
56786
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[email protected]
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Contact person for public queries
Name
56787
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Liz Bainbridge
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Address
56787
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School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth WA 6845
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Country
56787
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Australia
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Phone
56787
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+61 08 9266 3623
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Fax
56787
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Email
56787
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[email protected]
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Contact person for scientific queries
Name
56788
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Liz Bainbridge
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Address
56788
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School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth WA 6845
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Country
56788
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Australia
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Phone
56788
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+61 08 9266 3623
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Fax
56788
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Email
56788
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[email protected]
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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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
20 March 2019 Gaitan M, Bainbridge L, Parkinson S...
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More Details
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Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Characteristics of the shoulder in patients following acute stroke: a case series.
2019
https://dx.doi.org/10.1080/10749357.2019.1590973
N.B. These documents automatically identified may not have been verified by the study sponsor.
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