Reducing Fall Risk in Persons with Multiple Sclerosis who are Balance Impaired

1. Reducing Fall Risk in Persons with Multiple Sclerosis who are Balance Impaired Ellen Costello Susan Leach Joyce Maring Elizabeth Ruckert

2. Background • 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

3. Background • 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 (Motleet.al. 2013)

4. Background • 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.

5. THE PROPOSED STUDY In collaboration with the National Multiple Sclerosis Society. IRB in submission.

6. AIM #1 • 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

7. AIM #2 • 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).

8. Study Design – AIM #1 • 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).

9. Participants • Recruited by personnel of the National MS Society. • Must meet minimal criteria: 18-64 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.

10. Outcome Measures Non-physical measures: • Intake Form including demographics information and activities of daily living using the BarthelIndex •  Quality of Life Measure: the SF-36 • Activities-specific Balance Confidence Scale • Modified Fatigue Impact Scale

11. Outcome Measures 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

12. Data Analyses • 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.

13. AIM #2 • 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.

14. The Intervention • 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.

15. The Intervention 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.

16. GENERAL PROPOSED TIME LINES

17. THOUGHTS? QUESTIONS? IDEAS?