Protective Stepping in People With MS (PRO-STEP)

Effects of Protective Step Training in People With Multiple Sclerosis

Falls are common in Veterans with multiple sclerosis (MS), and current rehabilitation approaches to reduce falls are inadequate. Protective step training (in which a person is exposed to repeated "slips") is a promising tool to reduce falls in older adults. However, whether this approach is effective in people with MS is unknown. Investigating the effect of promising therapies, such as protective step training, will enhance our ability to treat Veterans with MS who are at risk for falls. Therefore, we will assess whether people with MS improve postural control and reduce falls through protective step training. we will also determine whether cognitive ability or brain structure can predict who will improve most. These data will inform clinical treatment strategies in people with MS at risk for falls.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Protective step training

Detailed Description

Current rehabilitation strategies to prevent falls in people with MS are inadequate. Protective step training is a novel and promising treatment in which people are exposed to repeated slips. This training aims to improve automatic postural control including quick, protective steps, which are a critical aspect of fall avoidance, and are delayed in people with MS. This therapy has been shown to prevent falls in healthy older adults. However, the effectiveness of perturbation training in Veterans with MS is unknown. Identifying effective methods of fall prevention in people with MS, such as perturbation training, can lead to fewer falls in this population.

People with MS often exhibit considerable variability in their "responsiveness" to rehabilitation. Said differently, improvement in performance through training is variable across individuals. The ability to predict responsiveness to treatment would be extremely beneficial for clinicians; improving the efficiency by which they provide care. Recent work suggests cognitive ability and structural brain connectivity may predict responsiveness to motor rehabilitation. However, the degree to which these characteristics predict responsiveness in people with MS is currently unknown.

Therefore, the overall goals of this project are to understand 1) whether people with MS can improve postural control and reduce falls through perturbation training, and 2) whether the investigators can predict (via cognitive testing and neuroimaging), who will benefit most from treatment. The investigators will achieve these goals through three specific aims. Aim 1: identify whether people with MS can improve protective stepping, a critical skill for fall prevention, through 2 weeks of protective step training. Aim 2: determine if cognitive capacity predicts postural improvement through training in people with MS. Aim 3: determine if brain structural connectivity predicts postural improvements through training. The imaging data collected will also allow the investigators to investigate whether MS-related changes in brain connectivity contributes to postural response dysfunction.

The efficacy of perturbation training in people with MS (Aim 1) will be studied by measuring protective stepping performance before and after a 2-week perturbation training protocol. In addition, the investigators will gather prospective falls data through a falls calendar over the course of 8 weeks prior to and 8 weeks after the perturbation training to gain preliminary data regarding the effect of this training on falls. To determine which baseline characteristics predict "responsiveness" to training (Aims 2 and 3), the investigators will also assess baseline cognitive capacity and brain structural integrity (via diffusion tensor imaging; DTI). The investigators will determine whether these baseline participant characteristics predict which participants exhibit the most improvement through the course of training.

This project will provide insight into 1) the effectiveness of a promising fall prevention intervention, and 2) the ability to predict which patients will benefit most from the intervention. This knowledge will be an important step toward improving care of people with MS who are at risk for falls.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Phoenix VA Health Care System, Phoenix, AZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Neurologist diagnosed MS (for MS participants only)
• Ability to Stand for 5 minutes without aid
• Ability to comprehend English
• At risk for falls (determined via questionnaire; for MS participants only)
• EDMUS score <7 (determined by testers)

Exclusion Criteria:

• Any non-MS neurological pathology
• Orthopedic impairments affecting balance
• Previous cardiac events (stroke or heart attack)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Step training; This group will undergo a baseline control period, as well as an intervention period. As such, they will serve as their own control subjects.	Behavioral: Protective step training; Participants will undergo 2 weeks of training, in which they will be exposed to repeated slips on a treadmill. This approach is aimed at improving protective steps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Training-related Change in Margin of Stability	Margin of Stability is a measure of stepping effectiveness; characterized as the difference between the extrapolated center of mass and the base of support at the instance of first foot contact. The primary endpoint was the change in Margin of Stability before to after training (i.e. Baseline to Post-test). The units of this measure are in meters. Large values represent better steps. So, positive change scores represent improvement in stepping.	Baseline and Post-test (immediately after the intervention)
Symbol Digit Modality Test	The Symbol Digit Modality Test (SDMT) is a cognitive assessment that probes processing speed. The score is the number of symbols and digits that one correctly matches over 90 seconds, and is assessed via paper and pencil. As such, the lower bound is 0, and there is no upper bound. Larger values are better.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Training-related Changes in Reactive Step Length	Reactive Step Length is the length of the first step after the participant loses their balance. The primary endpoint was the immediate change in performance through training (i.e., initial training period; Base2-Post1). The primary endpoint was the change in Reactive Step Length before to after training (i.e., Baseline to Post-test). The units of this measure are in meters. Large values represent better steps. So, positive change scores represent improvement in stepping.	Baseline and Post-test (immediately after the intervention)
Training-related Change in Reactive Step Latency	Reactive Step Latency is the time between when the balance perturbation occurs to lift-off of the foot. The primary endpoint was the change in performance through training (i.e., Baseline to Post-test). Smaller values represent faster (better) steps. So, negative change scores represent improvement in stepping through training.	Baseline and Post-test (immediately after 2 week intervention)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Arizona State University
• Investigators: Principal Investigator: Daniel S Peterson, PhD MS BS, Phoenix VA Health Care System, Phoenix, AZ

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Multiple Sclerosis; Posture; Cognition; Neuroimaging; Falls
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: B2341-W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD will be collected at Arizona State University, and thus will be accessible by study-team members at this institution.
• IPD Sharing Time Frame: Data collected at ASU will be stored indefinitely.
• IPD Sharing Access Criteria: Only approved study-team members at ASU will have access to IPD. These individuals will be identified and personally trained by the PI on the grant (Dr. Peterson).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No