Effects of Physical Therapy and Dalfampridine on Functional Mobility and Lower Extremity Strength in Non Ambulatory Persons With Multiple Sclerosis
Overview
- Phase
- Phase 2
- Intervention
- Dalfampridine Pill
- Conditions
- Multiple Sclerosis
- Sponsor
- D'Youville College
- Enrollment
- 35
- Primary Endpoint
- MSQOL -54
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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:
- Does the addition of dalfampridine to Physical Therapy improve functional outcomes compared to Physical Therapy alone
- Does Physical Therapy improve functional outcomes in patients who are non ambulatory
Detailed 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.
Investigators
Lacey Bromley
Project Manager
D'Youville College
Eligibility 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
Arms & Interventions
Drug Group
Intervention: Dalfampridine Pill
Placebo Group
Intervention: Placebo
Outcomes
Primary Outcomes
MSQOL -54
Time Frame: 12 weeks
Five time Sit to Stand
Time Frame: 12 weeks
Secondary Outcomes
- Symbol Digit Modalities Test(12 weeks)
- Wheel chair to Mat transfers - Functional Independence Measure(12 weeks)
- Standing Tolerance(12 weeks)
- 9 Hole Peg Test(12 weeks)