Ellen Costello Susan Leach Joyce Maring Elizabeth Ruckert

 Multiple sclerosis (MS): ◦ Immune mediated response ◦ Body’s immune system attacks the CNS (T cells attack myelin and nerves) ◦ Unknown etiology (genetic predisposition and possible environmental factors) ◦ Disease course and range of symptoms varies significantly

 Persons with MS experience: ◦ A high incidence of falls (Peterson et.al., 2008) ◦ Injuries associated with falls (Gibson, 2011) ◦ A lower quality of life (Coote, 2014) ◦ Decreased physical activity and functional status (Motle et.al. 2013)

 The National MS Society developed a Free From Falls (FFF) program. ◦ Program has both an educational and exercise component. ◦ Implemented over 8 weeks in a group format.  Pilot data (pre and post test data) collected by the National MS Society suggests the program may reduce fall risk in persons with MS.  Society requested GW serve as a site for the FFF program.

In collaboration with the National Multiple Sclerosis Society. IRB in submission.

 Determine whether participants with MS completing the Free From Falls program experience improvements in balance, strength, endurance, function, quality of life, and fall risk as compared to a control group with MS who have not completed the program

 To determine the validity and reliability of 3 outcome measures for use in persons with MS: ◦ The 2 Minute Walk Test (2MWT) ◦ The Figure 8 Walking Test (F8W), ◦ the 5X Sit To Stand Test (5xSTS test)  Validated in other patient populations.  Recommended by the The American Physical Therapy Association’s Neurology Task Force for research to determine clinical utility in persons with MS (Potter et al., 2014).

 Pretest-posttest control group design  10 weeks (including the pretests and posttests)  An additional 6 month follow-up test. Participants enrolled on a "first come first served" basis.  First 24 eligible participants assigned to the experimental group.  Subsequent 24 eligible participants will serve as a control group. Control group participants offered an opportunity to complete the 8 week program the next time it is offered (projected Spring 2015).

 Recruited by personnel of the National MS Society.  Must meet minimal criteria: years of age; confirmed MS; at risk for falls (history and/or fear of falls).  Sign medical waiver and refer to research team. Team completes further eligibility for study including several inclusion/exclusion criteria. Representative examples: ◦ Walk 50 feet independently with or without a straight cane. Understand and read English. ◦ Several measures of unstable cardiovascular or pulmonary involvement, other health conditions (e.g. CVA, PD) may exclude the subject.

Non-physical measures:  Intake Form including demographics information and activities of daily living using the Barthel Index  Quality of Life Measure: the SF-36  Activities-specific Balance Confidence Scale  Modified Fatigue Impact Scale

Physical measures:  Grip strength  Five Times Sit to Stand  Maximum Step Length forwards, sideways, backwards  Preferred and maximum 25 foot (or 10 m) gait speed performed on Zeno Walkway System which measures Center of Pressure (COP  5 m Walk backwards test performed on Zeno Walkway System.  Figure of 8 test performed on Zeno Walkway System  Six minute walk test  Two minute walk test  Timed Up and Go (TUG), TUG (Cognitive), TUG (Manual)  Berg Balance Scale  Sensation testing including proprioception and protective sensation

 Means and standard deviations  Compare the experimental and control groups at pretest using analysis of variance (ANOVA) for continuous measures (e.g. age) and chi-square tests for dichotomous measures (e.g. gender).  Repeated measures ANOVA with time as a within subject factor and intervention as a between-subject factor will be used to compare 2 groups over time.  Pre and posttest scores assessed separately for each group using bivariate tests. Continuous data will be analyzed used paired t-tests and McNamar tests will be used for dichotomous outcomes.  All tests will be two-tailed, with a significance criterion at p<0.05. To control for family-wise error when making multiple comparisons, alpha level will be modified using a Bonferroni adjustment.

 Same recruitment, pretest, and post test procedures  Analyses will specifically determine the strength of associations between the 3 identified measures (2MWT, F8W test, and 5xSTS test) with other validated measures of endurance, advanced walking skills, and functional strength included in the outcome measurements.

 Slightly modified FFF program. Manuals and proposed activities provided by the National MS Society.  Includes 8 sessions of 120 minutes (once weekly).  One hour educational presentation and discussion; one hour exercise/fitness.  Supervised by GW research team.

General Program Goals:  to increase the participants’ awareness of risk factors that contribute to falls;  to identify strategies they can employ to prevent and manage falls;  to engage in and develop a fitness plan that addresses balance, endurance, and strength;  to increase confidence in minimizing and managing falls;  to identify community resources to implement an ongoing fall prevention action plan.

Sept-Oct Recruitment and assignment to groups Pretest (week 1) Oct-Dec Intervention (week 2-9) Post test (week 10) May-June 6 month follow-up (Control group given opportunity to participate in FFF in Spring 2014)