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Protective Stepping & MS (PRO-STEP)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protective step training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Falls, Posture, Rehabilitation, Cognition, Neuroimaging

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Phoenix VA Health Care System, Phoenix, AZRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Step training

Arm Description

This group will undergo a baseline control period, as well as an intervention period. As such, they will serve as their own control subjects.

Outcomes

Primary Outcome Measures

Change in Margin of Stability over training compared to change over baseline
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. Large values represent better steps. The investigators will assess the change in scores across the baseline (2 week) and intervention (2 week) periods.
Symbol Digit Modality Test
This cognitive assessment probes processing speed, is assessed via paper and pencil, and will be correlated to improvement in stepping through training.
Brain structural connectivity
Structural connectivity within the "locomotor region" will be assessed via diffusion tensor imaging and will be correlated to improvement in stepping through training

Secondary Outcome Measures

Change in Step Length over training period compared to change over baseline period
Length of first protective step. The investigators will assess the change in scores across the baseline (2 week) and intervention (2 week) periods.
Change in Step Latency (treadmill) over training period compared to change over baseline period
time from perturbation onset to step initiation. The investigators will assess the change in scores across the baseline (2 week) and intervention (2 week) periods.

Full Information

First Posted
May 29, 2018
Last Updated
September 8, 2023
Sponsor
VA Office of Research and Development
Collaborators
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT03551665
Brief Title
Protective Stepping & MS
Acronym
PRO-STEP
Official Title
Protective Step Training in People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
July 24, 2024 (Anticipated)
Study Completion Date
July 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Arizona State University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Falls, Posture, Rehabilitation, Cognition, Neuroimaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multiple-baseline, within-subject design
Masking
None (Open Label)
Masking Description
Primary outcomes are objective (i.e. assessed via computer algorithms), thus reducing the need for masking.
Allocation
N/A
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Step training
Arm Type
Experimental
Arm Description
This group will undergo a baseline control period, as well as an intervention period. As such, they will serve as their own control subjects.
Intervention Type
Behavioral
Intervention Name(s)
Protective step training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Margin of Stability over training compared to change over baseline
Description
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. Large values represent better steps. The investigators will assess the change in scores across the baseline (2 week) and intervention (2 week) periods.
Time Frame
Baseline 1, Baseline 2 (2 weeks after baseline 1), Post-test 1 (immediately after 2 week intervention)
Title
Symbol Digit Modality Test
Description
This cognitive assessment probes processing speed, is assessed via paper and pencil, and will be correlated to improvement in stepping through training.
Time Frame
Baseline 1
Title
Brain structural connectivity
Description
Structural connectivity within the "locomotor region" will be assessed via diffusion tensor imaging and will be correlated to improvement in stepping through training
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in Step Length over training period compared to change over baseline period
Description
Length of first protective step. The investigators will assess the change in scores across the baseline (2 week) and intervention (2 week) periods.
Time Frame
Baseline 1, Baseline 2 (2 weeks after baseline 1), Post-test 1 (immediately after 2 week intervention)
Title
Change in Step Latency (treadmill) over training period compared to change over baseline period
Description
time from perturbation onset to step initiation. The investigators will assess the change in scores across the baseline (2 week) and intervention (2 week) periods.
Time Frame
Baseline 1, Baseline 2 (2 weeks after baseline 1), Post-test 1 (immediately after 2 week intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel S Peterson, PhD MS BS
Phone
(602) 277-5551
Ext
6094
Email
daniel.peterson1@asu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Soren Peterson, PhD MS BS
Organizational Affiliation
Phoenix VA Health Care System, Phoenix, AZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Health Care System, Phoenix, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel S Peterson, PhD MS BS
Phone
(602) 277-5551
Ext
6094
Email
daniel.peterson1@asu.edu
First Name & Middle Initial & Last Name & Degree
Daniel Soren Peterson, PhD MS BS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

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Protective Stepping & MS

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