A new study shows that a measure that is often used to measure walking speed in people with MS may provide benchmarks of the extent of disease progression and the impact of MS on a person’s daily activities and function. This may provide one element to help address the critical need for more sensitive and accurate ways to measure MS disability and extent of progression. Myla D. Goldman, MD, MSc (University of Virginia, Charlottesville, VA) and colleagues report their study in Neurology
(published online, October 30, 2013). This study was funded by Biogen Idec and the ziMS Foundation.
Disease progression, or gradual worsening, experienced by people who have MS usually occurs over many years, and it is often difficult to track with the standard clinical measurement scales used by doctors to assess disease activity. There has been some progress in developing improved imaging tools as windows to MS nervous tissue damage, but progress in developing outcome measures that can accurately track a person’s clinical condition has been slow.
Problems with walking (gait) are among the most common challenges for people with MS. One useful measure of walking ability is gait speed, and a test called the “Timed 25-Foot Walk” (T25-FW) is a reliable tool to assess gait speed. For this test, the individual is directed to one end of a clearly marked 25-foot course and is instructed to walk as quickly as possible, but safely. For the current study, Dr. Goldman and team explored how this test relates to the life and function of a person with MS, and to the progression of disability.
The team recruited 300 people with MS (relapsing or progressive forms) who had undergone a T25-FW test during the previous 15 months. They mailed a questionnaire to collect information on marital status, employment, activities of daily living (such as cooking and cleaning), use of assistive devices, walking function, and depression. The results were confirmed in a second group of 95 people with MS.
The investigators found that participants who took longer than six seconds to walk 25 feet were more likely to be unemployed, to have had a change in occupation due to MS and walking difficulties, to use a cane, and to require assistance with daily activities. Those who took eight seconds or longer were even more likely to be unemployed, to be covered by Medicaid or Medicare, to be divorced, to walk with a walker, and to be over 70 percent more likely to be unable to perform daily activities. Regarding employment, 59% of those who took less than six seconds to walk 25 feet were employed, and 43% reported a change in occupation due to MS, compared with 29% and 71% (respectively) of those who took longer than six seconds.
These findings suggest that T25-FW walk times of slower than 6 and 8 seconds may represent two benchmarks that are related to impairments in important life activities. Further research is needed to understand how clinically meaningful these benchmarks are and how useful they might be to clinicians and researchers in tracking MS progression over time.
The need to develop better clinical outcome measures to improve MS clinical trials of investigational therapies is the aim of the Multiple Sclerosis Outcome Assessments Consortium (MSOAC), launched by the National MS Society and Critical Path Institute. This coalition of industry, academia, patient representatives, regulatory agencies, and the Society will leverage existing data to develop a modified tool to track disability as a primary endpoint for future MS trials.
Over the 4-year, $3 million project, MSOAC will enable collection of clinical data from many MS clinical trials, which will then be standardized and analyzed to arrive at a consensus on the optimal measures for inclusion in this tool. This will then be advanced to the U.S. FDA and EMA (European Medicines Agency) for regulatory approval. This effort should lead to a new way to measure MS progression. Read more.