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Clinical Trial Summary

The goal of this interventional double blind, randomized placebo controlled trial was to assess the change in functional mobility, quality of life and cognition for subjects who receive physical therapy and take dalfampridine vs those who receive physical therapy and take a placebo in non ambulatory persons with multiple sclerosis. The main question[s] it aims to answer are: 1. Does the addition of dalfampridine to Physical Therapy improve functional outcomes compared to Physical Therapy alone 2. Does Physical Therapy improve functional outcomes in patients who are non ambulatory


Clinical Trial Description

This randomized control trial examined the effectiveness of dalfampridine when administered in conjunction with 12 weeks of physical therapy compared to physical therapy and a placebo on function, quality of life (QoL) and cognition in non-ambulatory pwMS. Specific Aim 1: Assess the change in standing tolerance, transfers, repeated sit to stand, QoL and cognitive processing for non-ambulatory individuals with MS between subjects on Dalfampridine who receive physical therapy and those who participate in physical therapy and receive a placebo. Enhancing the propagation of action potentials along axons in addition to regularly contracting the muscles through exercise may have a greater effect on strength and functional mobility. Specific Aim 2: Assess the functional, strength and cognitive changes within all subjects receiving PT 2x a week for 12 weeks. Evidence supporting the effectiveness of physical therapy in this population is extremely limited. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05859802
Study type Interventional
Source D'Youville College
Contact
Status Completed
Phase Phase 2/Phase 3
Start date July 13, 2011
Completion date January 9, 2016

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