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Completed

NCT Number: NCT05859802

Effects of Physical Therapy and Dalfampridine on Functional Mobility 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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dalfampridine Pill

Drug

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

Placebo

Drug

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

Primary outcomes

  1. MSQOL -54

    Time frame: Baseline

  2. MSQOL -54

    Time frame: 6 weeks

  3. MSQOL -54

    Time frame: 12 weeks

  4. Five time Sit to Stand

    Time frame: Baseline

  5. Five time Sit to Stand

    Time frame: 6 weeks

  6. Five time Sit to Stand

    Time frame: 12 weeks

Secondary outcomes

  1. Symbol Digit Modalities Test

    Time frame: Baseline

  2. Symbol Digit Modalities Test

    Time frame: 6 weeks

  3. Symbol Digit Modalities Test

    Time frame: 12 weeks

  4. Wheel chair to Mat transfers - Functional Independence Measure

    Time frame: Baseline

  5. Wheel chair to Mat transfers - Functional Independence Measure

    Time frame: 6 weeks

  6. Wheel chair to Mat transfers - Functional Independence Measure

    Time frame: 12 weeks

  7. Standing Tolerance

    Time frame: Baseline

    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.

  8. Standing Tolerance

    Time frame: 6 weeks

    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.

  9. Standing Tolerance

    Time frame: 12 weeks

    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.

  10. 9 Hole Peg Test

    Time frame: Baseline

  11. 9 Hole Peg Test

    Time frame: 6 weeks

  12. 9 Hole Peg Test

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

D'Youville College

Other

Collaborators

  • Acorda Therapeutics
  • University at Buffalo

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
May 16, 2023
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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