What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis aimed at improving motor function and reducing fall risk include physiotherapy, exercise programs, and medications like dimethyl fumarate and glatiramer acetate. Physiotherapy and exercise programs, such as backward walking training, generally have minimal side effects but may cause temporary muscle soreness or fatigue. Dimethyl fumarate can cause flushing, gastrointestinal issues, and a decrease in white blood cell count. Glatiramer acetate may lead to injection site reactions, chest pain, and lipoatrophy. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Sclerosis (MS) that focus on improving motor function and reducing fall risk include disease-modifying therapies such as glatiramer acetate and dimethyl fumarate. Glatiramer acetate, an immunomodulator, has been shown to reduce relapse rates and slow disability progression. Dimethyl fumarate, an oral formulation, significantly reduces relapse rates and the development of new brain lesions. These treatments aim to manage symptoms and improve the quality of life for MS patients, complementing non-pharmacologic interventions like backward walking training.

What other types of research exist?

Promising novel alternatives to Backward Walking Training for MS patients include: 1) Body Weight-Supported Treadmill Training (BWSTT), which has shown potential in reducing gait impairment; 2) Robot-Assisted Gait Training, which offers task-repetitive gait training and has demonstrated significant improvements in gait; 3) Multimodal Physical Therapy Programs, which include a combination of traditional physiotherapy, hydrotherapy, and sensory-based treatments to enhance motor function and balance.

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Backward vs Forward Walking Training for Multiple Sclerosis (TRAIN-BW Trial)

N/A

Recruiting

Led By Nora Fritz, PhD

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PDDS <6, indicating ability to ambulate with or without an assistive device >/= 50% of the time

Diagnosis of MS

Must not have

Comorbid neurological disorder

Unable to follow study-related commands

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if practicing walking backward can help people with multiple sclerosis (MS) improve their balance and reduce their risk of falling. People with MS often have trouble with mobility and thinking, leading to frequent falls. Current methods like forward walking exercises haven't been very effective. The study will compare backward walking to forward walking to see which is better for improving motor function and preventing falls.

Who is the study for?

This trial is for individuals with multiple sclerosis who have trouble walking or have fallen at least twice in the past six months. They must be able to walk with or without help most of the time and not be in a current MS relapse. People can't join if they have other neurological disorders, can't follow instructions, or have recent orthopedic injuries.

What is being tested?

The study compares backward walking training (BW) to forward walking training (FW) to see which is better at improving motor function and reducing fall risk in people with multiple sclerosis. It's checking if BW training could be a feasible and acceptable method for these patients.

What are the potential side effects?

Since this trial involves physical exercise interventions rather than medication, side effects may include muscle soreness, fatigue, joint pain, or increased risk of falls during the training sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk with or without help more than half the time.

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I have been diagnosed with multiple sclerosis (MS).

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I often have trouble walking or have fallen twice or more in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological disorder.

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I can follow instructions related to the study.

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I have a recent bone injury or disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stepping latency on push-and-release test

Sway during quiet stance

Secondary study objectives

ABC Scale

Client Satisfaction Questionnaire (CSQ-8)

Forward and Backward Velocity and Double Support Time

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TRAIN-BWExperimental Treatment1 Intervention

1x/week for 8 weeks + home exercise program

Group II: TRAIN-FWActive Control1 Intervention

1x/week for 8 weeks + home exercise program

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Backward Walking Training

2017

N/A

~130

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) such as dimethyl fumarate, glatiramer acetate, and cannabinoids. Dimethyl fumarate works by activating the Nrf2 pathway, which reduces oxidative stress and inflammation, while glatiramer acetate modulates the immune response to prevent myelin damage. Cannabinoids, although less consistent in efficacy, aim to manage symptoms like spasticity and pain. These treatments are crucial for MS patients as they help reduce relapse rates, slow disease progression, and improve quality of life. Additionally, nonpharmacologic interventions like backward walking training can enhance motor function and reduce fall risk, addressing mobility impairments that are common in MS.