Cases in Bioethics: Health Research Ethics in Southeast Asia
Keywords

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

  1. What, if any, concerns do you have regarding the inception and design of the study?

  2. What preliminary evidence is necessary before a medical device is tested with human research participants? Was there enough evidence in this case?

  3. Are there ethically meaningful differences when testing medical devices and treatments in clinical settings compared to at home?

  4. Do you believe the research team took adequate steps to manage risk to research participants? Why or why not?

References

Clark, Victoria M., and Adrian M. Burden. “A 4-Week Wobble Board Exercise Programme Improved Muscle Onset Latency and Perceived Stability in Individuals with a Functionally Unstable Ankle.” Physical Therapy in Sport 6, no. 4 (November 1, 2005): 181–87. https://doi.org/10.1016/j.ptsp.2005.08.003.
Correia, Camil, Kevin J. Lopez, Kristen E. Wroblewski, Megan Huisingh-Scheetz, David W. Kern, Rachel C. Chen, L P. Schumm, William Dale, Martha K. McClintock, and Jayant M. Pinto. “Global Sensory Impairment in Older Adults in the United States.” Journal of the American Geriatrics Society 64, no. 2 (February 2016): 306–13. https://doi.org/10.1111/jgs.13955.
Dougherty, John, Anne Kancel, Cassandra Ramar, Crystal Meacham, and Stephen Derrington. “The Effects of a Multi-Axis Balance Board Intervention Program in an Elderly Population.” Missouri Medicine 108, no. 2 (2011): 128–32. https://pubmed.ncbi.nlm.nih.gov/21568236.
Mattacola, Carl G., and Maureen K. Dwyer. “Rehabilitation of the Ankle after Acute Sprain or Chronic Instability.” Journal of Athletic Training 37, no. 4 (December 1, 2002): 413–29. https://pubmed.ncbi.nlm.nih.gov/12937563.
Nolan, Melissa, Jennifer Nitz, Nancy Low Choy, and Sara Illing. “Age-Related Changes in Musculoskeletal Function, Balance and Mobility Measures in Men Aged 30–80 Years.” The Aging Male 13, no. 3 (May 4, 2010): 194–201. https://doi.org/10.3109/13685531003657818.
Ogaya, Shinya, Tome Ikezoe, Naoki Soda, and Noriaki Ichihashi. “Effects of Balance Training Using Wobble Boards in the Elderly.” Journal of Strength and Conditioning Research 25, no. 9 (September 2011): 2616–22. https://doi.org/10.1519/jsc.0b013e31820019cf.
Siriphorn, Akkradate, and Dannaovarat Chamonchant. “Wii Balance Board Exercise Improves Balance and Lower Limb Muscle Strength of Overweight Young Adults.” Journal of Physical Therapy Science 27, no. 1 (2015): 41–46. https://doi.org/10.1589/jpts.27.41.
Verhagen, Evert, Allard van der Beek, Jos Twisk, Lex Bouter, Roald Bahr, and Willem van Mechelen. “The Effect of a Proprioceptive Balance Board Training Program for the Prevention of Ankle Sprains.” The American Journal of Sports Medicine 32, no. 6 (September 2004): 1385–93. https://doi.org/10.1177/0363546503262177.
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