Effects of Physical Therapy and Dalfampridine on Functional Mobility in Non Ambulatory Persons With Multiple Sclerosis

• Status: Completed
• Trial end date: 2016-01-09
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: D'Youville College
• Collaborators: Acorda Therapeutics; University at Buffalo
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria:

• Age 20 years or older confirmed MS diagnosis

• Expanded Disability Status Scale (EDSS) of 7.0 or higher

• No steroid treatment in the last 30 days or a relapse in the last 90 days, and MS considered stable

• Capable of performing requirements of Physical Therapy (PT) treatment including at least a 2/5 manual muscle test in 50% or more of the major muscle groups

Exclusion Criteria:

• History of seizure disorder

• Major cognitive or mental illness that prevented their ability to provide consent

• Evidence of other medical cause of cognitive impairment besides MS

• Severe joint contractures that limited the patients ability to move within full active range of motion