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Dynamic Balance Training in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic balance walking training
Sponsored by
Marquette University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants have been clinically diagnosed with multiple sclerosis
  • Must be capable of walking 10 meters independently with no physical assistance
  • Must be able to ascend/descend a small staircase (5 steps)
  • Medically stable
  • Able to give informed consent

Exclusion Criteria:

  • they suffer from cognitive deficits that prevent them from following 1 step commands
  • unable to give informed consent
  • if they suffer from significant cardiovascular problems, respiratory failure, major orthopedic problems, or other medical conditions that affect balance (e.g. diabetic neuropathy, myopathy, or vertigo)
  • Significant medical comorbidity or concurrent illness limiting their capacity to conform to study requirements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Training Group

    Control Group

    Arm Description

    During the 12-training day sessions, subjects will walk on the treadmill for a total of 30 minutes. Participants will walk at a comfortable pace while we perform controlled movements to the treadmill system. Subjects will be fitted with a fall-arrest harness and assisted onto the treadmill system. In the dynamic balance training group, we will move the motion base as participants walk in order to challenge their balance.

    Subjects who are in the control group will also walk on the treadmill, but the motion base will remain stationary. They will complete 12-training day sessions.

    Outcomes

    Primary Outcome Measures

    Change in Functional Gait Assessment
    The functional gait assessment (FGA) is a clinically accepted tool and is used to measure postural stability before and after the proposed walking paradigm.
    Change in Dynamic Stability
    Dynamic Stability is assessed using the margin of stability (MoS). The MoS is defined as the center of mass position and velocity relative to the edge of the person's base of support. If the center of mass falls outside the base of support, the individual may require corrective action to restore balance and/or be at higher risk for loss of balance. For this study, we measured the center of mass motion and foot placement (i.e., base of support) in the medio-lateral direction to calculate each person's MoS before and after the 4-week walking sessions.
    Change in Step Width
    Step width was measured for all individuals as the distance (centimeters) between the left and right ankle during double-limb support of each gait cycle. We measured step width before and after the 4-week walking sessions.

    Secondary Outcome Measures

    Change in Step Length
    Step Length was measured for all individuals as the distance (centimeters) between the left big toe and right big toe at the time the heel of the leading foot made contact with the treadmill belt at each gait cycle. We measured step length before and after the 4-week walking sessions.
    Change in Step Frequency
    Step Frequency was measured for all individuals as the number of steps occurring within a 60-second time window (units of Hz). We measured step frequency before and after the 4-week walking sessions.
    Change in 10-Meter Walk Test
    The 10-Meter Walk Test was administered at self-selected overground walking speeds for each individual. We assess walking speed with this tool before and after the proposed walking paradigm.

    Full Information

    First Posted
    September 4, 2020
    Last Updated
    January 20, 2021
    Sponsor
    Marquette University
    Collaborators
    Greater Milwaukee Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04719494
    Brief Title
    Dynamic Balance Training in Multiple Sclerosis
    Official Title
    Dynamic Balance Training in Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    May 31, 2019 (Actual)
    Study Completion Date
    August 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marquette University
    Collaborators
    Greater Milwaukee Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study will test a new technique for improving balance while walking in people with multiple sclerosis (MS). The technique focuses on having people with MS safely practice walking on simulated, uneven terrain that challenges balance and more accurately mimics walking in the community. The goal is to improve balance while walking in order to improve mobility and decrease the risk of falls. Recently, we developed a state-of-the-art treadmill system that allows us to create a challenging walking environment by placing a treadmill onto a motion base. We are able to simulate uneven terrain through movements of the walking surface while maintaining a safe walking environment. We will use this system to conduct tests of balance while walking and to train people to walk on uneven surfaces. Our objective is to evaluate the use of uneven terrain for training gait and balance in people with MS. Participants will undergo a four-week training protocol designed to disrupt and challenge balance while walking. We anticipate that training on uneven terrain will enhance gait stability, improve overall walking function and balance and increase balance confidence compared to training on a stable surface.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Training Group
    Arm Type
    Experimental
    Arm Description
    During the 12-training day sessions, subjects will walk on the treadmill for a total of 30 minutes. Participants will walk at a comfortable pace while we perform controlled movements to the treadmill system. Subjects will be fitted with a fall-arrest harness and assisted onto the treadmill system. In the dynamic balance training group, we will move the motion base as participants walk in order to challenge their balance.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Subjects who are in the control group will also walk on the treadmill, but the motion base will remain stationary. They will complete 12-training day sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Dynamic balance walking training
    Intervention Description
    Participants in the training group will walk on an elevated treadmill that will move side-to-side in a pseudorandom manner, thereby increasing the difficulty to their balance. Participants are asked to walk independently for 30-minutes per session, for 12 days over 4 weeks.
    Primary Outcome Measure Information:
    Title
    Change in Functional Gait Assessment
    Description
    The functional gait assessment (FGA) is a clinically accepted tool and is used to measure postural stability before and after the proposed walking paradigm.
    Time Frame
    Before and after training (occurs within 5-week period)
    Title
    Change in Dynamic Stability
    Description
    Dynamic Stability is assessed using the margin of stability (MoS). The MoS is defined as the center of mass position and velocity relative to the edge of the person's base of support. If the center of mass falls outside the base of support, the individual may require corrective action to restore balance and/or be at higher risk for loss of balance. For this study, we measured the center of mass motion and foot placement (i.e., base of support) in the medio-lateral direction to calculate each person's MoS before and after the 4-week walking sessions.
    Time Frame
    Before and after training (occurs within 5-week period)
    Title
    Change in Step Width
    Description
    Step width was measured for all individuals as the distance (centimeters) between the left and right ankle during double-limb support of each gait cycle. We measured step width before and after the 4-week walking sessions.
    Time Frame
    Before and after training (occurs within 5-week period)
    Secondary Outcome Measure Information:
    Title
    Change in Step Length
    Description
    Step Length was measured for all individuals as the distance (centimeters) between the left big toe and right big toe at the time the heel of the leading foot made contact with the treadmill belt at each gait cycle. We measured step length before and after the 4-week walking sessions.
    Time Frame
    Before and after training (occurs within 5-week period)
    Title
    Change in Step Frequency
    Description
    Step Frequency was measured for all individuals as the number of steps occurring within a 60-second time window (units of Hz). We measured step frequency before and after the 4-week walking sessions.
    Time Frame
    Before and after training (occurs within 5-week period)
    Title
    Change in 10-Meter Walk Test
    Description
    The 10-Meter Walk Test was administered at self-selected overground walking speeds for each individual. We assess walking speed with this tool before and after the proposed walking paradigm.
    Time Frame
    Before and after training (occurs within 5-week period)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants have been clinically diagnosed with multiple sclerosis Must be capable of walking 10 meters independently with no physical assistance Must be able to ascend/descend a small staircase (5 steps) Medically stable Able to give informed consent Exclusion Criteria: they suffer from cognitive deficits that prevent them from following 1 step commands unable to give informed consent if they suffer from significant cardiovascular problems, respiratory failure, major orthopedic problems, or other medical conditions that affect balance (e.g. diabetic neuropathy, myopathy, or vertigo) Significant medical comorbidity or concurrent illness limiting their capacity to conform to study requirements

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Dynamic Balance Training in Multiple Sclerosis

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