Effects of Physical Therapy and Dalfampridine on Functional Mobility in Non Ambulatory Persons With Multiple Sclerosis

Effects of Physical Therapy and Dalfampridine on Functional Mobility and Lower Extremity Strength in Non Ambulatory Persons With Multiple Sclerosis

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Dalfampridine Pill; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Drug: 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
Experimental: Drug Group	Drug: 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; Other Names: Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MSQOL -54	Baseline
MSQOL -54	6 weeks
MSQOL -54	12 weeks
Five time Sit to Stand	Baseline
Five time Sit to Stand	6 weeks
Five time Sit to Stand	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symbol Digit Modalities Test		Baseline
Symbol Digit Modalities Test		6 weeks
Symbol Digit Modalities Test		12 weeks
Wheel chair to Mat transfers - Functional Independence Measure		Baseline
Wheel chair to Mat transfers - Functional Independence Measure		6 weeks
Wheel chair to Mat transfers - Functional Independence Measure		12 weeks
Standing Tolerance	Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter [at the sink cutout area]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded.	Baseline
Standing Tolerance	Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter [at the sink cutout area]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded.	6 weeks
Standing Tolerance	Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter [at the sink cutout area]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded.	12 weeks
9 Hole Peg Test		Baseline
9 Hole Peg Test		6 weeks
9 Hole Peg Test		12 weeks

Collaborators and Investigators

• Sponsor: D'Youville College
• Collaborators: University at Buffalo; Acorda Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2011
• Primary Completion (Actual): March 3, 2015
• Study Completion (Actual): January 9, 2016

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Cognition; Functional Mobility; Dalfampridine; Non ambulatory
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Potassium Channel Blockers; 4-Aminopyridine
• Other Study ID Numbers: RMD0690511A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No