Effects of PT and Dalfampridine On Mobility and Strength in Subjects With MS

Background: Epidemiologic studies have shown that within 15 years after the onset of MS, 50% of individuals will require the use of an aid for walking and 10% will require a wheelchair. Twenty-five years after disease onset, approximately 90% of those with MS will have significant functional limitation and disability with 50% of those individuals requiring a wheelchair for mobility.

Objectives: Specific Aim 1: To assess the change in standing tolerance, transfers, repeated sit to stand, arm and leg strength for non-ambulatory individuals and individuals that walk limited distances (<20 meters) with MS between subjects on Dalfampridine and physical therapy and those on placebo and physical therapy.  Specific Aim 2:  To assess within the group receiving physical therapy and placebo the change in standing tolerance, transfers, repeated sit to stand, arm and leg strength. Specific Aim 3: To assess change in cognitive processing between subjects who participate in physical therapy and Dalfampradine 10mg bid and those subjects that receive physical therapy alone.

Methods: Forty-five non ambulatory subjects and subjects limited in distance walked, meeting an Expanded Disability Status Scale 6.5 to 8.0, will be randomized into 2 groups; Group 1 will receive physical therapy for 12 weeks while taking Dalfampradine 10 mg 2x/day and Group 2 will receive physical therapy while taking a placebo pill 2x/day. Both groups will receive physical therapy treatment two times per week and perform a home exercise program three times per week.  All subjects in Groups 1 and 2 will:  1) complete the MS Quality of Life 54; Spasm Frequency Scale; and Symbol Digit Modalities Test  2) Undergo a baseline physical therapy evaluation 3) Perform the following tests specific to this study:  9-Hole Peg test; Dynamometer test of strength in the upper and lower extremities; Grip and Pinch strength; Transfer onto a low mat table and return; Maintain static sitting for 30 seconds; Seated Functional reach; Standing tolerance; Repeated sit to stand test five repetitions. The physical therapy program will be 45 minute sessions 2 times a week for 12 weeks; prescribed home exercise program will be performed 3x/week. All subjects are tested twice for pretest, at 6 weeks, 12 weeks and 2 follow-ups.  Statistical analysis will include t-test, ANOVA and Regression Analysis.

Results: Preliminary analysis suggests a trend in improved performance in the repeated sit-to-stand test and standing tolerance test.

Conclusions: NA