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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dalfampridine Pill
Placebo
Sponsored by
D'Youville College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Dalfampridine, Functional Mobility, Non ambulatory, Cognition, Quality of Life

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Drug Group

    Placebo Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    MSQOL -54
    MSQOL -54
    MSQOL -54
    Five time Sit to Stand
    Five time Sit to Stand
    Five time Sit to Stand

    Secondary Outcome Measures

    Symbol Digit Modalities Test
    Symbol Digit Modalities Test
    Symbol Digit Modalities Test
    Wheel chair to Mat transfers - Functional Independence Measure
    Wheel chair to Mat transfers - Functional Independence Measure
    Wheel chair to Mat transfers - Functional Independence Measure
    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.
    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.
    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.
    9 Hole Peg Test
    9 Hole Peg Test
    9 Hole Peg Test

    Full Information

    First Posted
    April 27, 2023
    Last Updated
    May 5, 2023
    Sponsor
    D'Youville College
    Collaborators
    Acorda Therapeutics, University at Buffalo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05859802
    Brief Title
    Effects of Physical Therapy and Dalfampridine on Functional Mobility in Non Ambulatory Persons With Multiple Sclerosis
    Official Title
    Effects of Physical Therapy and Dalfampridine on Functional Mobility and Lower Extremity Strength in Non Ambulatory Persons With Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    July 13, 2011 (Actual)
    Primary Completion Date
    March 3, 2015 (Actual)
    Study Completion Date
    January 9, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    D'Youville College
    Collaborators
    Acorda Therapeutics, University at Buffalo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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: Does the addition of dalfampridine to Physical Therapy improve functional outcomes compared to Physical Therapy alone Does Physical Therapy improve functional outcomes in patients who are non ambulatory
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Dalfampridine, Functional Mobility, Non ambulatory, Cognition, Quality of Life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy for 12 weeks while taking Dalfampradine 10 mg two times day and Group 2 received physical therapy while taking a placebo pill two times a day. Both investigators that were preforming the testing and treatment were blinded as to subject group assignment.
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Drug Group
    Arm Type
    Experimental
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Dalfampridine Pill
    Other Intervention Name(s)
    Physical Therapy
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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 Outcome Measure Information:
    Title
    MSQOL -54
    Time Frame
    Baseline
    Title
    MSQOL -54
    Time Frame
    6 weeks
    Title
    MSQOL -54
    Time Frame
    12 weeks
    Title
    Five time Sit to Stand
    Time Frame
    Baseline
    Title
    Five time Sit to Stand
    Time Frame
    6 weeks
    Title
    Five time Sit to Stand
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Symbol Digit Modalities Test
    Time Frame
    Baseline
    Title
    Symbol Digit Modalities Test
    Time Frame
    6 weeks
    Title
    Symbol Digit Modalities Test
    Time Frame
    12 weeks
    Title
    Wheel chair to Mat transfers - Functional Independence Measure
    Time Frame
    Baseline
    Title
    Wheel chair to Mat transfers - Functional Independence Measure
    Time Frame
    6 weeks
    Title
    Wheel chair to Mat transfers - Functional Independence Measure
    Time Frame
    12 weeks
    Title
    Standing Tolerance
    Description
    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.
    Time Frame
    Baseline
    Title
    Standing Tolerance
    Description
    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.
    Time Frame
    6 weeks
    Title
    Standing Tolerance
    Description
    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.
    Time Frame
    12 weeks
    Title
    9 Hole Peg Test
    Time Frame
    Baseline
    Title
    9 Hole Peg Test
    Time Frame
    6 weeks
    Title
    9 Hole Peg Test
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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