device research, risks, safety, insurance, device research, home-based research, home-based research, elderly population
Humans’ ability to maintain balance deteriorates with age,1 leading to falls being more common in older people. Contributing factors include declining motor function, sensory capabilities, and the ability to integrate both.2 Also known as a balance board, a wobble board is used as a training device for postural stability. These devices can prevent falls in the elderly,3,4 improve body awareness among people with ankle injury5,6,7 or balance disorders, and improve muscle control.8
A local inventor in Malaysia equipped a conventional wobble board with virtual reality and marketed the device as fitness equipment to improve balance. Clinical testing in healthy people revealed its potential for reducing the risk of falls by improving balance through sustained use. Seeking to potentially expand its use in older people, the inventor asked a research team to test the ability of this device to prevent falls in this population. The researchers worked with the local inventor who donated wobble boards that had been modified by adding a holding frame and foam padding as safety precautions to reduce the risk of falls when using the device. The researchers designed a study to evaluate the effectiveness of the modified wobble board in healthy people 60-70 years of age. They planned to use conventional clinical tools used for assessment of functional balance and mobility, such as the Berg Balance Scale and “Time Up and Go.”
The study involved a home-based, 6-week balance training program using the virtual reality- equipped wobble board. Each research participant received a board to use 30 minutes per session, five times per week, supervised by a family member to ensure safety. Participants were asked to submit a photo taken during training sessions as proof of participation as well as to complete a training log after each training session. The research team assessed participants at home four times during the study period. Participants received modest financial compensation for taking part in the research. The research team acquired trial insurance to manage any potential claims of research-related injury made by research participants.
Questions
What, if any, concerns do you have regarding the inception and design of the study?
What preliminary evidence is necessary before a medical device is tested with human research participants? Was there enough evidence in this case?
Are there ethically meaningful differences when testing medical devices and treatments in clinical settings compared to at home?
Do you believe the research team took adequate steps to manage risk to research participants? Why or why not?