Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
The effectiveness of kinesiology taping for shoulder on pain and motor control in patients after stroke
Secondary ID [1] 286593 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 294888 0
Condition category
Condition code
Neurological 295133 295133 0 0
Other neurological disorders
Stroke 295205 295205 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 291710 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 294895 0
Pain, assessed using a visual analog scale, and the Ritchie Articular Index.
Timepoint [1] 294895 0
Fourteen days or discharge from the ward - whichever comes first.
Secondary outcome [1] 314297 0
Range of movement of shoulder external rotation, measured in degrees using a goniometer
Timepoint [1] 314297 0
Fourteen days or discharge from the ward - whichever comes first.
Secondary outcome [2] 314298 0
Motor recovery, measured using the Chedoke-McMaster impairment assessment inventory.
Timepoint [2] 314298 0
Fourteen days or discharge from the ward - whichever comes first.
Secondary outcome [3] 314670 0
Range of movement of shoulder flexion, measured in degrees using a goniometer
Timepoint [3] 314670 0
Fourteen days or discharge from the ward - whichever comes first.
Secondary outcome [4] 314671 0
Range of movement of shoulder abduction, measured in degrees using a goniometer
Timepoint [4] 314671 0
Fourteen days or discharge from the ward - whichever comes first.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Pilot study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2015
Actual
16/09/2015
Date of last participant enrolment
Anticipated
10/12/2015
Actual
25/02/2016
Date of last data collection
Anticipated
Actual
18/03/2016
Sample size
Target
40
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3731 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 9604 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 291159 0
Self funded/Unfunded
Name [1] 291159 0
N/A
Country [1] 291159 0
Primary sponsor type
Hospital
Name
Physiotherapy Department, Sir Charles Gairdner Hospital
Address
Physiotherapy Department
A Block, Sir Charles Gairdner Hospital
Hospital Avenue,
Nedlands, Western Australia, 6009
Country
Australia
Secondary sponsor category [1] 289836 0
None
Name [1] 289836 0
Address [1] 289836 0
Country [1] 289836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292735 0
Sir Charles Gairdner Hospital HREC
Ethics committee address [1] 292735 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, Western Australia, 6009
Ethics committee country [1] 292735 0
Australia
Date submitted for ethics approval [1] 292735 0
28/04/2015
Approval date [1] 292735 0
21/08/2015
Ethics approval number [1] 292735 0
2015-051

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.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 56786 0
Ms Liz Bainbridge
Address 56786 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth WA 6845
Country 56786 0
Australia
Phone 56786 0
+61 08 9266 3623
Fax 56786 0
Email 56786 0
[email protected]
Contact person for public queries
Name 56787 0
Ms Liz Bainbridge
Address 56787 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth WA 6845
Country 56787 0
Australia
Phone 56787 0
+61 08 9266 3623
Fax 56787 0
Email 56787 0
[email protected]
Contact person for scientific queries
Name 56788 0
Ms Liz Bainbridge
Address 56788 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth WA 6845
Country 56788 0
Australia
Phone 56788 0
+61 08 9266 3623
Fax 56788 0
Email 56788 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4536Study results articleYes 20 March 2019 Gaitan M, Bainbridge L, Parkinson S... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCharacteristics of the shoulder in patients following acute stroke: a case series.2019https://dx.doi.org/10.1080/10749357.2019.1590973
N.B. These documents automatically identified may not have been verified by the study sponsor.