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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Gait Disorders, Neurologic; Accidental Fall
• Intervention / Treatment: Behavioral: Backward Walking Training; Behavioral: Forward Walking Training

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nora Fritz, PhD; Phone Number: 313-577-3495; Email: nnlwsu@gmail.com

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University
      • Contact: Nora Fritz, PhD, PT, DPT, NCS; Phone Number: (313) 577-3495; Email: nnlwsu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sway during quiet stance	Measured with APDM Sensors	Change in sway at 8 weeks
Stepping latency on push-and-release test	Measured with APDM Sensors	Change in stepping latency at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire (CSQ-8)	Scores range from 8-32, with high scores indicating greater satisfaction with the intervention	8 weeks
Patient Global Impression of Change	Perceived Treatment Effect; scores range from 1-7 with higher scores indicating greater perception of improvement related to the intervention.	8 weeks
Number of Active Minutes	Measured with Accelerometry, passively collected for a 1 week period prior to the intervention and again after the intervention concludes 8 weeks later.	Change in Physical Activity measures at 8 weeks
Number of Falls	Number of falls reported in 6 month period after the intervention ends	6 months
Forward and Backward Velocity and Double Support Time	Walking speed and double support time (spatiotemporal measures of gait)	Change in velocity and double support time at 8 weeks
ABC Scale	Balance confidence	Change in balance confidence at 8 weeks

Collaborators and Investigators

• Sponsor: Wayne State University
• Investigators: Principal Investigator: Nora Fritz, PhD, Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Neurorehabilitation; Backward Walking
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Sclerosis; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: URG20192020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No