Clinical trial NCT05859802: Effects of Physical Therapy and Dalfampridine on Functional Mobility in Non Ambulatory Persons With Multiple Sclerosis
Official title: Effects of Physical Therapy and Dalfampridine on Functional Mobility and Lower Extremity Strength in Non Ambulatory Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Keywords: Dalfampridine
Functional Mobility
Non ambulatory
Cognition
Quality of Life
Lead sponsor: D'Youville College
Sponsor class: OTHER
Collaborators: name: Acorda Therapeutics
name: University at Buffalo
First posted: 2023-05-16
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: MSQOL -54
timeFrame: Baseline
measure: MSQOL -54
timeFrame: 6 weeks
measure: MSQOL -54
timeFrame: 12 weeks
measure: Five time Sit to Stand
timeFrame: Baseline
measure: Five time Sit to Stand
timeFrame: 6 weeks
measure: Five time Sit to Stand
timeFrame: 12 weeks
Secondary outcomes:
measure: Symbol Digit Modalities Test
timeFrame: Baseline
measure: Symbol Digit Modalities Test
timeFrame: 6 weeks
measure: Symbol Digit Modalities Test
timeFrame: 12 weeks
measure: Wheel chair to Mat transfers - Functional Independence Measure
timeFrame: Baseline
measure: Wheel chair to Mat transfers - Functional Independence Measure
timeFrame: 6 weeks
measure: Wheel chair to Mat transfers - Functional Independence Measure
timeFrame: 12 weeks
measure: Standing Tolerance
timeFrame: Baseline
measure: Standing Tolerance
timeFrame: 6 weeks
measure: Standing Tolerance
timeFrame: 12 weeks
measure: 9 Hole Peg Test
timeFrame: Baseline
measure: 9 Hole Peg Test
timeFrame: 6 weeks
measure: 9 Hole Peg Test
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
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