Dual Density Study
PARTICIPANT INFORMATION SHEET
Version 1 – February 29, 2016
Study title: Understanding athletic footwear during walking and running: there effect on biomechanics, running economy and running performance.
You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. If you want to ask any questions that are not dealt with on this form please feel free to contact the investigators. Their details can be found at the end of the document. Take time to decide whether or not you wish to take part.
What is the purpose of the study?
We currently only have a limited understanding of the effects of athletic footwear on foot and lower limb motion and joint loading in people during walking and running activities. To be able to design better shoes, it is important we understand what is the effect of each design component inserted in the shoe. The purpose of this study is to find out more about the effects of different footwear design features on the biomechanics of the foot and lower limb during walking and running.
Do I have to take part?
Participation in either or both studies is voluntary. It is up to you to decide whether or not to take part. If you do decide to take part you will be required to sign a consent form. Participants are free to withdraw from the research project at any stage without affecting their status now or in the future. Participation in the second study is purely voluntary, and is not compulsory if enrolled into study one.
What time commitment is it to take part in the research?
An initial screening appointment takes 30 minutes. The study has two data collection sessions, which will last approximately 2 hours each. Total participation time for this study is therefore 4 hours. The data collection sessions will all take place at the Podiatry Clinic (Level 3, Centenary Building) and in the Gait Laboratory (P7-14), City East Campus, University of South Australia. A map of the campus is available on request. Participants will need to make their own way to City East Campus.
What do I have to do?
Firstly, you will need to attend the Podiatry Clinic (Level 3, Centenary Building, City East Campus, University of South Australia) to see if you are eligible for the study. You will be given another opportunity to read the participant information sheet and ask any questions about the study. If you agree to participate, you will be required to sign a consent form. You will need to complete a questionnaire about any medical history that will preclude you from participation, as well as having a number of measurements taken of your feet and body to assess your eligibility for participation.
If eligible and you agree to participate in the study, you will then need to attend the Gait Laboratory (P7-14) two times on separate day. At each session, you will be asked to change into a pair of running shorts (we provide these shorts) in a private change room. The following data collecton protocol will be used:
- You will have your height and weight measured.
- You will be asked to put on the shoes we provide to you. You will then have small reflective markers attached to the feet and legs. The reflective markers are applied with a mild, hypoallergenic tape.
- You will then walk along a 10-metre walkway where the markers will be recorded where the movements and forces of your joints will be recorded. You will be required to do this for approximately 10 walking trials.
- You will then be asked to run on a treadmill for approximately 20 minutes. This includes a 5 min warm-up on the treadmill, as well as three stints of five minutes running at set speeds of 8, 10 and 12 km/h. You will be given a 3-4 min break between each stint of running.
- You will then be asked to run five kilometres on a treadmill as fast as you can (termed 5km time-trial). You will have a 10 min break before this.
- After completing this 5km time-trial, you will have a 30 min break of no exercise
- After this break, you will again need to run on a treadmill for approximately 15 minutes (three stints of 5 min running at set speeds of 8, 10 and 12 km/h). You will be given a 3-4 min break between each stint of running.
- After this phase of running, you will be given a five minute break, and then asked to perform a second 5km time-trial. You will again be asked to run these five kilometres on a treadmill as fast as you can. This will allow us to assess the effect of fatigue on your running performance.
- You will then be able to change back into your other clothes in the private change room. You will be provided a time for your second and final testing session (one week gap between testing session). This then completes the testing session.
Will I automatically take part in the study?
If you indicate your willingness to be part of the study you will need to answer a series of questions. These relate to your medical history that is relevant to the inclusion/exclusion criteria of this study. If you meet all the eligibility criteria, you will be eligible to participate in this study and invited to take part.
What are the possible disadvantages and risks of taking part?
Because you will be running time-trials and on a treadmill in a potentially fatigued state, there are potential risks of injury that need to be avoided. In the event that you feel uncomfortable on the treadmill or become overly fatigued, there are emergency-stops located on the handlebars of the treadmill. There are also handlebars on the treadmill for you to grip onto. These safety features will be pointed out to each participant prior to any data collection. A research staff member will also be observing data collection at all times, and they too have access to an emergency stop button for the treadmill. There are no other potential emotional, social or legal risks for you in this study, beyond those encountered in everyday life. If anything of concern is detected during the course of data collection or you have any concerns, you may withdraw from the study and be advised to contact your local doctor or Physiotherapist should any injury occur.
What are the possible benefits of taking part?
There are no direct benefits to you for participating in this study. The wider application of your participation though is to provide information that will be used to design shoes that are more protective from injury and that can make you run faster. You will also receive a pair of ASICS Kayano running shoes as an appreciation for participating in the study (RRP = $260).
Will my taking part in this study be kept confidential?
All records containing personal information will remain confidential and no information which could lead to the identification of any individual will be released. Consent forms will be stored separately from any other data or information in a locked filing cabinet in the office of the Principal researchers (room P7-13). It will not be possible to identify you from the motion data we record as the cameras do not take photographs or video, they will just record the position of the reflective markers we attached to you. All forms will be stored for a period of five (5) years in a locked filing cabinet and thereafter securely destroyed. All electronic data will be stored on a password-protected locations of the computer of the office of the principal investigator, Chris Bishop (P7-13) or on the biomechanics server share, accessed by a password-protected computer in P7-14.
**Note: Please note that data will be collected and used for other purposes and retained for future use. This includes future analyses, as well as the ability to identify your eligibility for any future related research studies.
Who is organizing and funding the research?
A research team from the School of Health Science (lead by Chris Bishop) at the University of South Australia is organizing this research. Chris Bishop is an ASICS funded Research Fellow. ASICS will be providing the footwear used in this study.
Will I receive a copy of the results?
If you would like a copy of the results, they are available on request from the research team. If you would like this, please contact Dr Chris Bishop by e-mail on christopher.bishop@unisa.edu.au.
Who has reviewed the study?
This study has been reviewed and approved by the University of South Australia’s Human Research Ethics Committee. If you have any ethical concerns or complaints about the project or questions about your rights as a participant please contact the Executive Officer of this Committee, Tel: +61 8 8302 3118, Email: Vicki.allen@unisa.edu.au.
Who else can I contact if I have any questions?
Please feel free to contact the principal investigator:
Dr Chris Bishop
School of Health Sciences
University of South Australia
Adelaide
Tel: 08 8302 1312
Email: christopher.bishop@unisa.edu.au
