Effects of Physical Therapy and Dalfampridine on Functional Mobility in Non Ambulatory Persons With Multiple Sclerosis
NCT ID: NCT05859802
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
35 participants
INTERVENTIONAL
2011-07-13
2016-01-09
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Both investigators that were preforming the testing and treatment were blinded as to subject group assignment.
Study Groups
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Drug Group
Dalfampridine Pill
Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking dalfampridine 10 mg two times day
Placebo Group
Placebo
Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking a placebo pill two times day
Interventions
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Dalfampridine Pill
Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking dalfampridine 10 mg two times day
Placebo
Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking a placebo pill two times day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Acorda Therapeutics
INDUSTRY
University at Buffalo
OTHER
D'Youville College
OTHER
Responsible Party
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Lacey Bromley
Project Manager
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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RMD0690511A
Identifier Type: -
Identifier Source: org_study_id
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