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TRAIN-BW: Backward Walking Training in Multiple Sclerosis (TRAIN-BW)

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ClinicalTrials.gov Identifier: NCT04091464
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Nora Fritz, Wayne State University

Brief Summary:
Individuals with multiple sclerosis (MS) experience in impairments in mobility and cognition that increase the risk for accidental falls. More than 50% of individuals with MS experience injurious falls within a 6-month period. Current interventions to improve fall risk have focused on forward walking (FW) and balance training, resulting in small declines in the relative risk for falls with a large degree of variability. Interestingly, motor differences between MS and healthy controls are more pronounced in backward walking (BW), yet no studies have investigated BW training as an intervention to reduce fall risk in persons with MS. Further, the underlying pathological and cognitive factors that impact BW performance and its potential to impact fall risk in persons with MS remain unknown. This study will investigate the feasibility, acceptability and impact of BW training compared to forward walking training on motor function, brain structure, and fall risk in persons with MS.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Gait Disorders, Neurologic Accidental Fall Behavioral: Backward Walking Training Behavioral: Forward Walking Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: TRAIN-BW: Backward Walking Training in Multiple Sclerosis
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TRAIN-BW
1x/week for 8 weeks + home exercise program
Behavioral: Backward Walking Training
Training will consist of BW training on both a treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline BW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes BW, backward stepping, and functional exercises that incorporate BW movements.

Active Comparator: TRAIN-FW
1x/week for 8 weeks + home exercise program
Behavioral: Forward Walking Training
Training will consist of FW training on both treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline FW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes FW, forward stepping, and functional exercises that incorporate FW movements.




Primary Outcome Measures :
  1. backward walking velocity [ Time Frame: Change in Backward Walking Velocity at 8 weeks ]
    spatiotemporal measures of walking

  2. backward walking double support [ Time Frame: Change in Backward Walking Double Support at 8 weeks ]
    spatiotemporal measures of walking


Secondary Outcome Measures :
  1. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 8 weeks ]
    Scores range from 8-32, with high scores indicating greater satisfaction with the intervention

  2. Patient Global Impression of Change [ Time Frame: 8 weeks ]
    Perceived Treatment Effect; scores range from 1-7 with higher scores indicating greater perception of improvement related to the intervention.

  3. Number of Active Minutes [ Time Frame: Change in Physical Activity measures at 8 weeks ]
    Measured with Accelerometry, passively collected for a 1 week period prior to the intervention and again after the intervention concludes 8 weeks later.

  4. Number of Falls [ Time Frame: 3 months ]
    Number of falls reported in 3 month period after the intervention ends

  5. Brain Structure of Corticospinal Tract [ Time Frame: Change in Brain Structure at 8 weeks ]
    Microstructural integrity of corticospinal tract as measured with MRI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsing Remitting MS
  • PDDS <6, indicating ability to ambulate with or without an assistive device >/= 50% of the time
  • Self-reported walking dysfunction as evidenced by a score of >/= 30 on MSWS-12

Exclusion Criteria:

  • MS relapse within the past 30 days
  • comorbid neurological disorder
  • acute orthopedic disorder/injury
  • unable to follow study-related commands
  • implanted metal or other medical device that would preclude MRI scanning.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091464


Contacts
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Contact: Nora Fritz, PhD 313-577-3495 nnlwsu@gmail.com

Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Nora Fritz, PhD Wayne State University

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Responsible Party: Nora Fritz, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT04091464     History of Changes
Other Study ID Numbers: URG20192020
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nora Fritz, Wayne State University:
Backward Walking
Neurorehabilitation
Additional relevant MeSH terms:
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Multiple Sclerosis
Gait Disorders, Neurologic
Sclerosis
Nervous System Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Signs and Symptoms