Protective Stepping in People With MS

NCT03551665 | Completed Results

• 1 other identifier: B2341-W
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Falls; Posture; Rehabilitation; Cognition; Neuroimaging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Training-related Changes in Reactive Step Length

  Baseline and Post-test (immediately after the intervention)

• Training-related Change in Reactive Step Latency

  Baseline and Post-test (immediately after 2 week intervention)

Study Arms (1)

Step training

EXPERIMENTAL

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

Interventions

Protective step training BEHAVIORAL

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.

Step training

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Arizona State University: collaborator

Study Sites (1)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Technical problems with neuroimaging data analyses have resulted in unreliable or uninterpretable data at this time.

Results Point of Contact

• Title: Daniel Peterson
• Organization: Arizona State University

daniel.peterson1@asu.edu

602-543-9373

Study Officials

• Daniel S Peterson, PhD MS BS

  Phoenix VA Health Care System, Phoenix, AZ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Primary outcomes are objective (i.e. assessed via computer algorithms), thus reducing the need for masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Multiple-baseline, within-subject design

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: February 22, 2019
• Primary Completion: July 24, 2024
• Study Completion: August 1, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data collected at ASU will be stored indefinitely.
• 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).

Locations

US (1)