|Study Title:||The progressive effect of relapsing-remitting multiple sclerosis on gait variability using a body-fixed accelerometer|
|Rationale:||The purpose of this study is to investigate how walking patterns change in people with relapse-remitting multiple sclerosis depending on the progression of the disease.|
Multiple sclerosis (MS) is a degenerative disease of the central nervous system that can cause a variety of debilitating symptoms. Some of these symptoms have been shown to cause changes in gait variability, which can decrease mobility related to quality of life and increase the risk of falling. By studying how gait changes throughout the progression of MS, a better understanding will be developed of how and when motor control changes occur, while quantifying the magnitudes of these changes, which will provide an objective measure for clinical assessment of disease severity and treatment options. Therefore, this study will attempt to answer several questions about gait variability in people with MS using a body-fixed sensor (accelerometer) as a measurement device.
In this study, you will walk for up to 10-minutes around a 200-metre track at a self-selected walking speed. A motion sensor will be placed on your lower back with a strap. This sensor will track your body’s movements as you walk. The recorded movements will be used to assess the variability of your stride using specialized data analysis software.
Prior to the walking trial, we will collect basic demographic information (e.g. height and weight), as well as some information about your history with multiple sclerosis. We will use this information to classify the stage of your MS according to an accepted scale (EDSS), allowing for the comparison of walking data at various stages of the disease. You will also complete a questionnaire: the Modified Fatigue Impact Scale. This questionnaire is a reliable and valid instrument that will be used to help control for the effects of fatigue on gait, respectively. The session will take approximately 45 minutes.
Your participation in this study is on a voluntary basis. You will not receive any direct benefit or compensation for your participation in the study. The results of this research study may be used for a Master’s thesis, journal articles, and conference or clinical presentations. You are free to withdraw from the study at any time prior to the release of the published results. The estimated release date of the study results is December 2021. There are no known risks or side effects associated with participating in this study.
|Recruitment Dates:||2020-06-01 to 2020-12-31|
|Who can participate:||Individuals diagnosed with relapsing-remitting multiple sclerosis with an EDSS between 2 and 5 who can walk for at least 6 minutes without resting or an aid and have been relapse free for at least 30 days. Eligible participants will have no other health or orthopedic condition that impairs balance or gait, no cognitive or psychiatric condition that would impair their ability to walk or provide consent, no cardiovascular or respiratory disorders, not pregnant, and no fampridine use within the last 4 weeks.|
|Location of Trial:||University of Regina|
|Contact Information:|| Russell Kohrs & John Barden
|Trial Funding:||Saskatchewan Health Research Foundation|