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Active, Not Recruiting

NCT Number: NCT04091464

TRAIN-BW: Backward Walking Training in Multiple Sclerosis

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. This study will investigate the feasibility, acceptability and impact of BW training compared to forward walking training on motor function and fall risk in persons with MS.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Accidental Fall Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Gait Disorders, Neurologic Immune System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of 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 OR reports of 2 or more falls in the prior 6 months, indicating a frequent faller.

Exclusion criteria

  • MS relapse within the past 30 days
  • comorbid neurological disorder
  • acute orthopedic disorder/injury
  • unable to follow study-related commands

Treatment and study plan

Backward Walking Training

Behavioral

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.

Forward Walking Training

Behavioral

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 outcomes

  1. Sway during quiet stance

    Time frame: Change in sway at 8 weeks

    Measured with APDM Sensors

  2. Stepping latency on push-and-release test

    Time frame: Change in stepping latency at 8 weeks

    Measured with APDM Sensors

Secondary outcomes

  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: 6 months

    Number of falls reported in 6 month period after the intervention ends

  5. Forward and Backward Velocity and Double Support Time

    Time frame: Change in velocity and double support time at 8 weeks

    Walking speed and double support time (spatiotemporal measures of gait)

  6. ABC Scale

    Time frame: Change in balance confidence at 8 weeks

    Balance confidence

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Acronym: TRAIN-BW

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2019
Registry last updated
Dec 15, 2025

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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