TRAIN-BW: Backward Walking Training in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— TRAIN-BW  

Official title:

TRAIN-BW: Backward Walking Training in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04091464
• Other study ID #: URG20192020
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Wayne State University
• Contact: Nora Fritz, PhD
• Phone: 313-577-3495
• Email: nnlwsu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accidental Fall
• Gait Disorders, Neurologic
• Multiple Sclerosis
• Nervous System Diseases
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sway during quiet stance	Measured with APDM Sensors	Change in sway at 8 weeks
Primary	Stepping latency on push-and-release test	Measured with APDM Sensors	Change in stepping latency at 8 weeks
Secondary	Client Satisfaction Questionnaire (CSQ-8)	Scores range from 8-32, with high scores indicating greater satisfaction with the intervention	8 weeks
Secondary	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
Secondary	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
Secondary	Number of Falls	Number of falls reported in 6 month period after the intervention ends	6 months
Secondary	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
Secondary	ABC Scale	Balance confidence	Change in balance confidence at 8 weeks