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Protective Step Training for Multiple Sclerosis (PRO-STEP Trial)

N/A

Recruiting

Led By Daniel Soren Peterson, PhD MS BS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to Stand for 5 minutes without aid

Neurologist diagnosed MS (for MS participants only)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline 1, baseline 2 (2 weeks after baseline 1), post-test 1 (immediately after 2 week intervention)

Awards & highlights

PRO-STEP Trial Summary

This trial will investigate whether protective step training can reduce falls in veterans with multiple sclerosis.

Who is the study for?

This trial is for Veterans with MS who can understand English, stand unaided for 5 minutes, have a neurologist's diagnosis of MS, are at risk of falling (as determined by a questionnaire), and have an EDMUS score below 7. It excludes those with other neurological issues, balance-affecting orthopedic impairments or past major cardiac events.Check my eligibility

What is being tested?

The study tests protective step training—a method where participants experience controlled 'slips' to improve their postural control and reduce falls. The effectiveness in people with MS will be evaluated along with how cognitive ability or brain structure may predict the most improvement.See study design

What are the potential side effects?

While not explicitly mentioned, potential side effects could include muscle soreness, fatigue from physical activity during the training sessions, and possibly stress or discomfort associated with experiencing controlled slips.

PRO-STEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can stand for 5 minutes without help.

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I have been diagnosed with MS by a neurologist.

PRO-STEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline 1, baseline 2 (2 weeks after baseline 1), post-test 1 (immediately after 2 week intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline 1, baseline 2 (2 weeks after baseline 1), post-test 1 (immediately after 2 week intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 1, baseline 2 (2 weeks after baseline 1), post-test 1 (immediately after 2 week intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain structural connectivity

Change in Margin of Stability over training compared to change over baseline

Symbol Digit Modality Test

Secondary outcome measures

Change in Step Latency (treadmill) over training period compared to change over baseline period

Change in Step Length over training period compared to change over baseline period

PRO-STEP Trial Design

1Treatment groups

Experimental Treatment

Group I: Step trainingExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,378 Total Patients Enrolled

15 Trials studying Multiple Sclerosis

1,147 Patients Enrolled for Multiple Sclerosis

Arizona State UniversityOTHER

283 Previous Clinical Trials

109,463 Total Patients Enrolled

2 Trials studying Multiple Sclerosis

20,042 Patients Enrolled for Multiple Sclerosis

Daniel Soren Peterson, PhD MS BSPrincipal InvestigatorPhoenix VA Health Care System, Phoenix, AZ

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for entry into this medical experiment?

"For this clinical research, 51 individuals aged between 20 and 80 with multiple sclerosis are needed. Moreover, participants must: receive a neurologist's diagnosis of MS (for those with the condition), remain standing unaided for 5 minutes or longer, understand English fluently, be likely to fall according to the questionnaire (only applicable to MS cases); and have an EDMUS score less than 7 as determined by evaluators."

Answered by AI

How many participants are signing up for this trial?

"Affirmative. Visible on clinicaltrials.gov is the fact that this medical experiment is currently searching for recruits; it was initially listed on February 22nd 2019 and most recently modified on January 20th 2022. 51 individuals from one site must be enrolled in order to complete the trial."

Answered by AI

Are recruits being accepted for enrollment in this trial presently?

"Affirmative. The information posted on clinicaltrials.gov indicates that this medical research is in the process of finding volunteers. This trial was first uploaded to the website on February 22nd 2019 and has been updated as recently as January 20th 2022, with a total of 51 participants needed from 1 site."

Answered by AI