NCT04091464

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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

6.2 years

First QC Date

September 11, 2019

Last Update Submit

December 5, 2025

Conditions

Keywords

Backward WalkingNeurorehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Client Satisfaction Questionnaire (CSQ-8)

    8 weeks

  • Patient Global Impression of Change

    8 weeks

  • Number of Active Minutes

    Change in Physical Activity measures at 8 weeks

  • Number of Falls

    6 months

  • Forward and Backward Velocity and Double Support Time

    Change in velocity and double support time at 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

TRAIN-BW

EXPERIMENTAL

1x/week for 8 weeks + home exercise program

Behavioral: Backward Walking Training

TRAIN-FW

ACTIVE COMPARATOR

1x/week for 8 weeks + home exercise program

Behavioral: Forward Walking Training

Interventions

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.

TRAIN-FW

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.

TRAIN-BW

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Multiple SclerosisGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nora Fritz, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 16, 2019

Study Start

January 1, 2020

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations