Effects of Physical Therapy and Dalfampridine on Functional Mobility in Non Ambulatory Persons With Multiple Sclerosis
- Registration Number
- NCT05859802
- Lead Sponsor
- D'Youville College
- 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:
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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug Group Dalfampridine Pill - Placebo Group Placebo -
- Primary Outcome Measures
Name Time Method MSQOL -54 12 weeks Five time Sit to Stand 12 weeks
- Secondary Outcome Measures
Name Time Method Symbol Digit Modalities Test 12 weeks Wheel chair to Mat transfers - Functional Independence Measure 12 weeks Standing Tolerance 12 weeks Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter \[at the sink cutout area\]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded.
9 Hole Peg Test 12 weeks