Trial Outcomes & Findings for Protective Stepping in People With MS (NCT NCT03551665)

Last Updated: 2025-06-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

Baseline and Post-test (immediately after the intervention)

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Step Training (MS Group) This group of people with MS will undergo a baseline control period, as well as an intervention period. As such, they will serve as their own control subjects.	Step Training (Control Group) This group of people without MS will undergo a baseline control period, as well as an intervention period. As such, they will serve as their own control subjects.
Overall Study STARTED	38	19
Overall Study COMPLETED	27	17
Overall Study NOT COMPLETED	11	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Step Training (MS Group) This group of people with MS will undergo a baseline control period, as well as an intervention period. As such, they will serve as their own control subjects.	Step Training (Control Group) This group of people without MS will undergo a baseline control period, as well as an intervention period. As such, they will serve as their own control subjects.
Overall Study Lost to Follow-up	11	2

Baseline Characteristics

57 people were originally screened and enrolled (38 MS and 19 control). Of these, 44 completed the baseline testing.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Step Training (MS Group) n=27 Participants This group of people with MS will undergo a baseline control period, as well as an intervention period. As such, they will serve as their own control subjects.	Step Training (Control Group) n=17 Participants This group of people without MS will undergo a baseline control period, as well as an intervention period. As such, they will serve as their own control subjects.	Total n=44 Participants Total of all reporting groups
Age, Continuous	56.49 years STANDARD_DEVIATION 13.97 • n=5 Participants • 57 people were originally screened and enrolled (38 MS and 19 control). Of these, 44 completed the baseline testing.	58.31 years STANDARD_DEVIATION 19.30 • n=7 Participants • 57 people were originally screened and enrolled (38 MS and 19 control). Of these, 44 completed the baseline testing.	57.20 years STANDARD_DEVIATION 16.04 • n=5 Participants • 57 people were originally screened and enrolled (38 MS and 19 control). Of these, 44 completed the baseline testing.
Sex: Female, Male Female	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	14 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Post-test (immediately after the intervention)

Outcome measures

Outcome measures
Measure	Step Training (MS Group) n=27 Participants People with multiple sclerosis	Step Training (Control Group) n=17 Participants People without MS.
Training-related Change in Margin of Stability	0.0289 meters Standard Deviation 0.0777	0.0217 meters Standard Deviation 0.119

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Step Training (MS Group) n=27 Participants People with multiple sclerosis	Step Training (Control Group) n=17 Participants People without MS.
Symbol Digit Modality Test	42.44 Units on a scale Standard Deviation 10.33	51.88 Units on a scale Standard Deviation 8.44

SECONDARY outcome

Timeframe: Baseline and Post-test (immediately after the intervention)

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.

Outcome measures

Outcome measures
Measure	Step Training (MS Group) n=27 Participants People with multiple sclerosis	Step Training (Control Group) n=17 Participants People without MS.
Training-related Changes in Reactive Step Length	0.026 meters Standard Deviation 0.086	0.023 meters Standard Deviation 0.063

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Step Training (MS Group) n=27 Participants People with multiple sclerosis	Step Training (Control Group) n=17 Participants People without MS.
Training-related Change in Reactive Step Latency	-0.0414 seconds Standard Deviation 0.1047	0.0047 seconds Standard Deviation 0.0500

Adverse Events

Step Training (MS Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Step Training (Control Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Peterson

Arizona State University

Phone: 602-543-9373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place