Secondary outcomes
death, Muscle spasticity, insomnia, Insomnia, disability
SECONDARY, MULTIPLE SCLEROSIS
These included self-reported sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) at baseline, the end of the 10-week intervention, and 16-weeks post-intervention. The PSQI is a self-rated questionnaire to assess perceived sleep quality and disturbances over the prior one-month time interval [The Insomnia Severity Index (ISI) is a brief self-report screening tool of seven questions assessing sleep over the previous two weeks, including three questions rating difficulties with: 1) falling asleep; 2) staying awake and 3) early morning awakening on a five-point Likert scale ( ‘0’ = none to ‘4’ = very severe). Other questions rate dissatisfaction with current sleep pattern (‘0’ = very satisfied to ‘4’ = very dissatisfied); how noticeable sleep problems are to others (‘0’ = not at all to ‘4’ = very much); worried/distressed about current sleep problem (‘0’ = not at all to ‘4’ = very much) and interference with daily function (‘0’ = not at all to ‘4’ = very much). Total scores of 15 to 21 indicate moderate and scores of 22–28 indicate severe insomnia (Other secondary outcome measures included the self-reported Multiple Sclerosis Quality of Life Inventory (MSQLI) [Muscle spasticity was measured by the Modified Ashworth Scale (MAS) [The Expanded Disability Status Scale (EDSS) is a standard measure of physical and mental impairment in MS that is universally employed in MS studies and clinical practice. It consists of a set of subscale, measuring different neurological functions, and a ten-point ordinal scale that grades neurological findings in MS, ranging from no impairment (0), moderate disability (3.0 or higher), reliance on a unilateral assistive device to walk 100 m (6.0), wheelchair bound (7.0) and death from MS (10) (reference). The Principal Investigator, a Board Certified neurologist with more than two decades of experience in treating MS and participating in MS clinical trials, performed the EDSS examinations.