RecruitingPhase 4NCT06136728

Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

Dalfampridine Combined With Physical Therapy for Mobility Impairment in People With Multiple Sclerosis


Sponsor

MGH Institute of Health Professions

Enrollment

48 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 25 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether combining dalfampridine (a drug that may improve nerve signal conduction and walking ability in MS) with structured physical therapy produces better improvements in walking and mobility than physical therapy alone in people with multiple sclerosis (MS). **You may be eligible if...** - You have a confirmed diagnosis of MS - You have some walking difficulty (taking 6-45 seconds to walk 25 feet) - You can stand unsupported for at least 10 seconds - You have not had an MS relapse in the last 3 months - You are not currently taking dalfampridine and have not stopped it due to side effects - You score adequately on a cognitive screening test **You may NOT be eligible if...** - You have another neurological disease or orthopedic condition affecting your walking - You have a history of seizures - You have significant kidney impairment - You are pregnant, breastfeeding, or trying to become pregnant - You have uncontrolled high blood pressure or diabetes - You have been hospitalized for any reason in the last 3 months - You are currently receiving physical therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDalfampridine 10 MG [Ampyra]

Dalfampridine (10 mg) every 12 hours for 6 weeks.

BEHAVIORALPhysical therapy

Physical therapy (motor relearning for mobility and balance) one-on-one twice per week for 6 weeks.

OTHERDalfampridine plus physical therapy

Dalfampridine (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.


Locations(1)

MGH Institute of Health Professions

Boston, Massachusetts, United States

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NCT06136728


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