RECRUITING

Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-12
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06136728

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of MS
  2. * Expanded Disability Status Scale (EDSS) 6.5 or less
  3. * Timed 25-Foot Walk 6-45 seconds (average of 2 trials)
  4. * Able to stand unsupported for at least 10 seconds
  5. * Montreal Cognitive Assessment 23 or higher
  6. * Relapse free for at least 3 months
  7. * Not currently taking dalfampridine or not previously taken and discontinued due to adverse reactions
  8. * Not currently receiving physical therapy
  1. * Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity
  2. * Unable to follow a 3-step verbal command in English
  3. * Hospitalization for any reason in the last 3 months
  4. * Uncontrolled hypertension or diabetes
  5. * History of seizures
  6. * Renal impairment
  7. * Women who are breastfeeding, pregnant, or trying to become pregnant
  8. * Contraindications to magnetic resonance imaging (MRI; to be excluded from MRI procedures but may participate if all other criteria are met)

Contacts and Locations

Study Contact

Prudence Plummer, PhD
CONTACT
617-724-3103
pplummer@mghihp.edu

Principal Investigator

Prudence Plummer, PhD, PT
PRINCIPAL_INVESTIGATOR
MGH Institute of Health Professions

Study Locations (Sites)

MGH Institute of Health Professions
Boston, Massachusetts, 02129
United States

Collaborators and Investigators

Sponsor: MGH Institute of Health Professions

  • Prudence Plummer, PhD, PT, PRINCIPAL_INVESTIGATOR, MGH Institute of Health Professions

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-12
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-06-12
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Sclerosis