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High-Intensity Treadmill Training for Multiple Sclerosis

N/A
Recruiting
Led By Brian D Schmit, PhD
Research Sponsored by Marquette University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have no other concomitant neurological diseases, no history of epileptic seizures, peripheral nerve injury in lower legs or traumatic brain injury.
Participants will be between the age of 18 and 65 and have a body mass of less than 135kg (maximum mass for treadmill equipment).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before training, 1-2 weeks after all training sessions, 6 months after all training sessions
Awards & highlights

Study Summary

This trial combines intense exercise with walking on a shaky treadmill to improve walking speed, balance and walking in the community for people with MS. Measurements taken before, during, and after.

Who is the study for?
This trial is for adults aged 18-65 with multiple sclerosis (MS) who can walk 10 meters, have stable MS treatments and disease course, no severe medical conditions or recent heart attacks, and are not pregnant. They must be under 135kg in weight, able to follow commands, and commit to the training program.Check my eligibility
What is being tested?
The study tests whether high-intensity gait training on a shaky treadmill improves walking speed, balance, and community mobility in people with MS. Participants will undergo different combinations of intensity levels and stability during treadmill exercises.See study design
What are the potential side effects?
Potential side effects may include muscle soreness or fatigue due to high-intensity exercise. The shaky treadmill might cause dizziness or increase the risk of falls during training sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have no neurological diseases, seizures, nerve injuries in my legs, or brain injuries.
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I am between 18 and 65 years old and weigh less than 135kg.
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I haven't had a heart attack in the last month, my blood pressure is under control, I don't get dizzy standing up, and my diabetes is managed.
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I can walk and move my ankles, knees, and hips within a normal range.
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I can hear whispers and see clearly with glasses if needed.
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I can follow simple instructions.
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My MS treatments have been stable for 1 month, with no recent steroids or botulinum toxin injections above the knee.
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I am medically stable and do not have severe illnesses that would limit my ability to exercise.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before training, 1-2 weeks after all training sessions, 6 months after all training sessions
This trial's timeline: 3 weeks for screening, Varies for treatment, and before training, 1-2 weeks after all training sessions, 6 months after all training sessions for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in 6-minute walk test
Changes in Daily stepping activity
Changes in Functional Gait Assessment (FGA)
+1 more
Secondary outcome measures
Changes in Activities-specific Balance Confidence (ABC) score
Changes in Average Duration of Stepping Bouts
Changes in Berg Balance Scale
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Moderate-Intensity With PerturbationsExperimental Treatment2 Interventions
30 sessions of moderate-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.
Group II: High-Intensity With PertubationsExperimental Treatment2 Interventions
30 sessions of high-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.
Group III: High-Intensity No PerturbationsExperimental Treatment1 Intervention
30 sessions of high-intensity treadmill training will be conducted on a stable treadmill.
Group IV: Moderate-Intensity No PerturbationsActive Control1 Intervention
30 sessions of moderate-intensity treadmill training will be conducted on a stable treadmill.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,660,330 Total Patients Enrolled
18 Trials studying Multiple Sclerosis
1,658 Patients Enrolled for Multiple Sclerosis
Indiana UniversityOTHER
977 Previous Clinical Trials
983,163 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
15 Patients Enrolled for Multiple Sclerosis
Medical College of WisconsinOTHER
608 Previous Clinical Trials
1,162,361 Total Patients Enrolled

Media Library

High-Intensity Treadmill Training Clinical Trial Eligibility Overview. Trial Name: NCT05735691 — N/A
Multiple Sclerosis Research Study Groups: Moderate-Intensity No Perturbations, High-Intensity With Pertubations, Moderate-Intensity With Perturbations, High-Intensity No Perturbations
Multiple Sclerosis Clinical Trial 2023: High-Intensity Treadmill Training Highlights & Side Effects. Trial Name: NCT05735691 — N/A
High-Intensity Treadmill Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05735691 — N/A

Frequently Asked Questions

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

Could elderly individuals aged 85 and over partake in this experiment?

"According to the stated eligibility guidelines, patients must be between 18 and 65 years old in order to qualify for this clinical trial."

Answered by AI

Is recruitment into this investigation still ongoing?

"According to clinicaltrials.gov, this medical experiment is open for enrollment and was initially published on January 1st 2023 with the most recent update occurring on February 9th 2023."

Answered by AI

How many participants are currently involved in this clinical experiment?

"Affirmative. The information available on clinicaltrials.gov demonstrats that this medical trial is currently accepting participants and was initially posted on 1/1/2023 with the most recent update taking place 2/9/2023. A total of 150 individuals will be recruited from two distinct sites for this experiment."

Answered by AI

Could I qualify to join this medical trial?

"This clinical trial seeks 150 individuals aged 18 to 65 with an established diagnosis of multiple sclerosis according to the McDonald Criteria. Patient eligibility is contingent on several factors such as having a stable disease course, no exacerbations in the past four weeks, being able to follow three commands during a Mini Mental State Exam and medically stable without concurrent severe medical illnesses. Furthermore, participants must have adequate hearing (whisper test) and vision (minimum 20/80 corrected vision on a Snellen chart), not exceed 135 kg body mass index for treadmill equipment use and be free from myocardial infarction in the past month or uncontrolled hypertension (blood pressure"

Answered by AI

What is the focal purpose of this research initiative?

"The purpose of this trial, which will be tracked over the course of 5-6 weeks before training starts, 1-2 weeks after completion of all sessions and 6 months afterwards is to assess changes in Timed 25-foot walk test. Auxiliary outcomes include fluctuations in Berg Balance Scale, number of falls incidents and kinematic responses to unpredicted perturbations determined by motion capture technology measuring center mass displacement and base support as well as medial/lateral margin stability and anterior/posterior dynamic gait steadiness assessed with step sizes and trunk angles."

Answered by AI
~100 spots leftby Jun 2027