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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05859802
• Other study ID #: RMD0690511A
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 13, 2011
• Est. completion date: January 9, 2016

Study information

• Verified date: May 2023
• Source: D'Youville College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 9, 2016
• Est. primary completion date: March 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
D'Youville College	Acorda Therapeutics, University at Buffalo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MSQOL -54		Baseline
Primary	MSQOL -54		6 weeks
Primary	MSQOL -54		12 weeks
Primary	Five time Sit to Stand		Baseline
Primary	Five time Sit to Stand		6 weeks
Primary	Five time Sit to Stand		12 weeks
Secondary	Symbol Digit Modalities Test		Baseline
Secondary	Symbol Digit Modalities Test		6 weeks
Secondary	Symbol Digit Modalities Test		12 weeks
Secondary	Wheel chair to Mat transfers - Functional Independence Measure		Baseline
Secondary	Wheel chair to Mat transfers - Functional Independence Measure		6 weeks
Secondary	Wheel chair to Mat transfers - Functional Independence Measure		12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	9 Hole Peg Test		Baseline
Secondary	9 Hole Peg Test		6 weeks
Secondary	9 Hole Peg Test		12 weeks