Principal Investigators
Dr. Arshdeep Sidhu, PhD — Biological Systems Engineering Program, Plaksha University, Mohali (arshdeep.sidhu@plaksha.edu.in)
Dr. Deepan Muthirayan, PhD — Computer Science & Artificial Intelligence Program, Plaksha University, Mohali (deepan.muthirayan@plaksha.edu.in)
Prof. Andy Ruina, PhD — Robotics & Autonomous Systems, Plaksha University, Mohali (andy.ruina@plaksha.edu.in)
Dr. Navjot Kaur, MBBS, ENT Surgeon — Dr. B. R. Ambedkar State Institute of Medical Sciences, Mohali
Co-Investigators: Prof. TV Ramanathan, Plaksha University, Mohali (t.ramanathan@plaksha.edu.in)
Invitation
We invite you to participate in our research study as a volunteer, however before you decide to participate, it is critical that you understand our research and your role as a volunteer. Please read the following sections carefully and discuss with us about any doubt or additional information that you may require to make an independent informed decision.
Background to the Study
As people age, their balance gradually weakens making them more likely to fall — that can cause bone fractures and muscle-joint injuries. These injuries severely affect mobility and overall well-being of elderly as the recovery is slow and inefficient. We all know of some relative, friend or acquaintance who suffered such a fall. New research indicates that poor balance in elderly may correlate with higher chances of neurodegenerative diseases such as Parkinson's disease and Alzheimer's disease. Early detection of balance issues and active intervention can significantly improve the quality of life in elderly and in those with neurodegeneration.
Motivation of the Study
If we can understand factors that affect balance, we can likely prevent a large number of falls in elderly people. Injuries caused by these falls are a major reason for disability, dependence and poor quality of life in old age. We have developed a balance measuring platform, which can — just like a weighing scale — measure balance in healthy individuals and in patients with balance problems. The purpose of this study is to measure balance in a large number of people of different age, gender and lifestyles — to understand factors that affect balance in Indian population.
Can I participate and help?
Yes, we are looking for volunteers to participate in our academic study and help us create a database for balance in Indian population. Anyone who is interested in understanding their own balance and would like to contribute to science and society can participate in the study.
The datasets will include: Healthy individuals — volunteers with no history of fall; At risk — volunteers with a history of unintentional fall but no clinically diagnosed balance disorder; Patients — volunteers with clinically diagnosed balance disorder — each further split into Urban and Rural.
Do I have to participate?
Participation in this study is entirely voluntary. You are free to decline to participate without giving any reasons. Even if you consent now, you can withdraw from the study at any time, without any consequences. Though we would like to know the reasons for your withdrawal.
What will happen if I agree to participate?
On receiving your informed consent, we will ask for some details about your health and lifestyle, relevant to the project, to label your data effectively (10–15 mins) (questionnaire 2). Then we will explain and ask you to stand on our device, as one stands on a weighing scale. We will measure your balance in different stances, likely 5–6 stances (1 min each), ensuring your comfort and safety. In total, it will take about 30 mins to explain, collect details and measure balance.
What if I do not want to answer some of the questions?
It is your choice not to answer some of the questions and we will respect your choice. It is important for us that whichever question you choose to answer, you answer it truest to your knowledge. It will be detrimental to the study if you provide misleading answer(s).
Will I have to visit many times?
The baseline measurement for balance will be measured only once. At the end of the measurement, we will ask you if you want to participate in a follow-up or intervention study. According to your response, we will indicate if you need to come again, with details.
Will any invasive procedure be performed on me? / Are there any risks?
No, your participation involves only answering a few questions and standing on a platform for a few minutes. This is a completely non-invasive study and does not involve any risk beyond day-to-day standing on both legs or one leg.
What are the benefits of participating?
Your balance data is critical for us to understand factors that impact balance in Indian populations. You may not derive any direct or immediate material benefit from the study, but your data will help us build technologies and interventions to improve balance in the coming years. Volunteer participation is fundamental to advance human health research — every medication and medical device we use today to lead healthy and comfortable lives was once tested on volunteers.
Will my information and data be confidential?
Yes, your information and data will be strictly confidential. Your data will be coded with a linking key and stored in the university databases. Only researchers working on the project, at any given time, will have access to the data. Your data will be stored with no time limit, as long-term data is highly valuable for research purposes.
Can I ask for a copy of my data, or ask you to delete it?
Yes, only you can ask for a copy of your recorded data by raising a request through Form 3, or ask us to delete your data at any time by raising a request through Form 4 — contact the research team and they will assist with subsequent steps. Note: once you request deletion of your data, you will not be able to re-enrol in the study at a later date.
What will happen to the results of the study?
The results will be communicated to the broader research and clinical community through peer-reviewed publications, talks, seminars or reports. No volunteer will be identified in any communication. If you would like to understand your data better, you can contact us for an in-depth analysis as the research advances.
Compensation
You will not receive any monetary compensation for participating in this study.
Who has reviewed this study?
This study has been reviewed and approved by the Institutional Ethics Committee of Plaksha University.
Contact Information
Dr. Arshdeep Sidhu, Principal Investigator — arshdeep.sidhu@plaksha.edu.in — Phone: 0172 412 6394.
For questions about your rights as a volunteer, contact the Institutional Ethics Committee, Plaksha University.
Consent Statement
I have read and understood the information provided above. I have been given the opportunity to ask questions and my questions have been answered to my satisfaction.
I voluntarily agree to participate in this research study.