Full Research Title: "Recognizing left from right arms by individuals with stroke" - stroke laterality study

Participate if you can. Of course you should have already heard about this from your doctor, if any good at all.
http://research.noigroup.com/?_p=stls

1. Introduction

You are invited to participate in this research project which is investigating changes in people (with and without stroke) with upper limb pain. We know from previous research that some people with longstanding hand or arm pain have difficulty recognizing the laterality (left from right) of a picture of their affected hand (perception difficulties).
This research project requires participation from people who have had a stroke, as well as those that haven't, in order that we can make comparisons between these populations.

2. What is the purpose of this research project?

The purpose of this study is to investigate if people with stroke experience difficulty with recognizing the laterality of their affected arm and hand, and if there is a further relationship in those with upper limb pain. This could lead us to better understand upper limb pain in stroke and in turn help us to develop more effective treatment strategies.
To do this we will investigate the accuracy and response time for a left/right judgement task of the shoulder and hand in people who may or may not have had a stroke, and compare the results to those with upper limb pain.
You will need to be aged 18 or over, and have sufficient vision for both reading and looking at images on a computer screen in order to complete this study.

3. Who is conducting this study?

The study is being conducted by Brendon Haslam, a physiotherapist, and will form part of his requirements for the degree of Doctor of Philosophy at the University of Melbourne.
This study is under the supervision of:

• Professor Leeanne Carey, Florey Institute of Neuroscience and Mental Health at the University of Melbourne, and School of Allied Health at LaTrobe University.
• Dr David Butler, Neuro Orthopaedic Institute*, Adelaide.

Mr Halton Stewart, from the Neuro Orthopaedic Institute, has been responsible for software research and development.
We have come together to conduct a research project about upper limb pain in stroke. Software development has occurred with the generous support of the Neuro Orthopaedic Institute.
* The Neuro Orthopaedic Institute (NOI) (www.noigroup.com) is an Australian registered company with headquarters in Adelaide. NOI has organised conferences, seminars and university programs in the field of pain and rehabilitation, worldwide for over 25 years. NOI actively supports research in this field. Outcomes of this research may lead to further utilization of their Recognise product as part of future treatment strategies.

4. How much time will the study take?

Participation in this study, involving completion of the online questionnaire and interactive tasks will take approximately 30 minutes. It is possible to take rest breaks between sections which may result in longer times.

5. Procedures

If you agree to participate, you will be asked to complete some simple online questionnaires that involve answering some short questions, followed by looking at simple images on a computer screen and choosing whether these are left or right images. You will be able to complete this from a computer of your choice with internet access.
This study is carried out online and you will be guided through a five step process, involving:

• Providing consent to participate and information gained to be utilized in research, in addition to consenting to the terms and conditions of the NOI website, available at www.noigroup.com/en/Terms
• Completion of some questionnaires about yourself, including some questions about your arm (upper limb).
• Completion of a series of choice reaction tasks, where you will be asked to respond to a series of images by indicating whether it is a left or right image.

6. Possible benefits

While this research will increase knowledge of upper limb pain conditions in stroke and may improve treatment of this condition in the future, we cannot and do not guarantee or promise that you will receive any benefits from the study.

7. Possible risks

Participation in this study should not cause you any discomfort and to our knowledge there are no risks, as supported by previous similar studies.

8. Do I have to take part in this research project?

No. Your participation in this study is entirely voluntary. You are not under any obligation to consent and if you do consent you can withdraw at any time without affecting your relationship with The University of Melbourne, the Neuro Orthopaedic Institute, LaTrobe University or researchers. If you are currently undergoing treatment for upper limb pain, refusal to participate will not influence your management in any way. Whatever your decision, it will not affect your treatment or your relationship with researchers or therapy staff. You can withdraw from the study at any stage by just clicking the exit program link at the bottom of any of the web pages. However, once the study survey is completed, as it is anonymous, your data cannot be withdrawn.

9. How will I be informed of the final results of this research project?

At the completion of the study a report will be prepared that will contain group results. You may access this report via the www.noigroup.com website, and members of the Neuro Orthopaedic Institute database will be informed by mail out/newsletter when this occurs. This report may also be submitted for publication.

10. What will happen to the information about me?

All aspects of the project, including results will be strictly confidential and only researchers involved with the study will have access to your information. Your identity will remain anonymous in data storage systems and in any presentation or publications produced. A report of the study may be submitted for publication, but individual participants will not be identifiable in such a report. Data collected may be accessed for possible future related studies.

11. Can I access research information about me?

As all data collected is anonymous, information about individual participants will not be available, only the collated group data which will be presented in the report as detailed above.

12. Can I ask other people I know to participate?

Yes, the success of this research project relies on large numbers of participants who may or may not have had a stroke. As all information is anonymous, we request that you inform anyone who you think may be interested in participating in this project.

13. Is this research project approved?

This research project has been approved by the Human Research Ethics Committee of The University of Melbourne, in addition to the LaTrobe University Human Ethics Committee.

13. Who can I contact for further information?

If you would like to know more about this research or have any questions regarding this study please feel free to contact the following researchers:

• Mr Brendon Haslam haslamb@student.unimelb.edu.au
• Professor Leeanne Carey Leeanne.Carey@florey.edu.au
• Dr David Butler david@noigroup.com

14. What if I have a complaint or any concerns?

Any person with concerns or complaints about the conduct of this research project and wishes to speak to someone independent of the study investigators, can contact the Executive Officer, Human Research Ethics, The University of Melbourne, Phone:+61 3 8344 2073; Fax +61 3 9347 6739.
You will need to tell the Executive Officer the name of one of the researchers given in the introductory information section above.
*Please save or print a copy of this information sheet for your records

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