Effects of Protective Step Training in People With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT03551665

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Training-related Change in Margin of StabilityMean Difference (Final Values) .029.002–0.0560.036
Symbol Digit Modality TestSpearman's Rho .019.92

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Protective step training

Results by group

Training-related Change in Margin of Stability

Baseline and Post-test (immediately after the intervention)

GroupValueIntervalNumber analysed
Step Training (MS Group)0.0289 meters0.0777 (Standard Deviation)27
Step Training (Control Group)0.0217 meters0.119 (Standard Deviation)17

Step Training (MS Group)

0.0289

Step Training (Control Group)

0.0217

p = 0.036; Mean Difference (Final Values) .029 (95% CI .002–0.056)

Symbol Digit Modality Test

Baseline

GroupValueIntervalNumber analysed
MS Group42.44 Units on a scale10.33 (Standard Deviation)27
Step Training (Control Group)51.88 Units on a scale8.44 (Standard Deviation)17

MS Group

42.44

Step Training (Control Group)

51.88

p = .92; Spearman's Rho .019

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Step Training (MS Group)270 (0.0%)0
Step Training (Control Group)170 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Training-related Change in Margin of Stability

    Baseline and Post-test (immediately after the intervention)

  • Symbol Digit Modality Test

    Baseline

    Thinking and memory

Other measures (2)

  • Training-related Changes in Reactive Step Length

    Baseline and Post-test (immediately after the intervention)

    Walking and mobility
  • Training-related Change in Reactive Step Latency

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

    Myelin repairWalking and mobility

Who could take part

MS (type not specified) · 20 to 80

Show the full 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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Feb 2019

      2. Main results due

        Jul 2024

      3. Finished

        Aug 2024

      4. Results posted

        Jun 2025

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