About this trial
The goal of this clinical trial is to evaluate if combining a medication that can help improve walking in people with multiple sclerosis (MS) with a physical therapy program is better for improving walking than either treatment alone. The main questions this study will answer are:
* Does combining dalfampridine with physical therapy improve mobility more than physical therapy without concurrent dalfampridine? * Is the combined treatment associated with better outcomes than the medication (dalfampridine) on its own? * How do the individual treatments (dalfampridine, physical therapy) alone compare to each other?
Participants with MS-related mobility deficits will:
* Receive 6 weeks of dalfampridine treatment to assess the effects of this treatment. * After stopping the medication for 2 weeks, the investigators will re-evaluate walking, then randomly assign individuals to a 6-week physical therapy program. * Half of the participants will receive physical therapy while resuming dalfampridine treatment. The other half of the participants will receive physical therapy without resuming the medication.
Researchers will compare the combination treatment group (medication plus physical therapy) to the physical therapy only group to see if the combined treatment improves walking-related function. Approximately 3 months after finishing the physical therapy program, participants will undergo a final evaluation to see if the treatment effects have been maintained.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of MS
Expanded Disability Status Scale (EDSS) 6.5 or less
Timed 25-Foot Walk 6-45 seconds (average of 2 trials)
Able to stand unsupported for at least 10 seconds
Disqualifiers
Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity
Unable to follow a 3-step verbal command in English
Hospitalization for any reason in the last 3 months
Uncontrolled hypertension or diabetes
Trial design
Parallel
Treatments tested in this trial
Dalfampridine 10 MG [Ampyra]
DrugDalfampridine (10 mg) every 12 hours for 6 weeks.
Physical therapy
BehavioralPhysical therapy (motor relearning for mobility and balance) one-on-one twice per week for 6 weeks.
Dalfampridine plus physical therapy
Other interventionDalfampridine (10 mg) every 12 hours for 6 weeks while simultaneously receiving physical therapy (motor relearning for mobility and balance) one-on-one twice per week.
Treatment groups
Trial outcomes
Primary outcomes
Change in Timed 25-Foot Walk (T25FW)
The T25FW is a test that times how long in seconds a person can walk 25 feet from standing start as quickly as possible. We will assess the change in T25FW between baseline and end of treatment for each phase of the treatment (1: dalfampridine only run-in; 1: physical therapy with our without dalfampridine)
Sponsors and contacts
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