← Back to Search

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
Be older than 18 years old
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

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.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) that target the immune system to reduce inflammation and slow disease progression, and symptomatic treatments like physical therapy and exercise. Intense exercise improves walking speed and endurance by enhancing cardiovascular fitness and muscle strength, while the shaky treadmill enhances balance by challenging the body's stability and proprioception. These mechanisms are crucial for MS patients as they help mitigate mobility issues, reduce the risk of falls, and improve overall quality of life.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,373 Total Patients Enrolled
18 Trials studying Multiple Sclerosis
1,658 Patients Enrolled for Multiple Sclerosis
Indiana UniversityOTHER
997 Previous Clinical Trials
1,095,444 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
15 Patients Enrolled for Multiple Sclerosis
Medical College of WisconsinOTHER
614 Previous Clinical Trials
1,162,729 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 With Perturbations, Moderate-Intensity No Perturbations, High-Intensity No Perturbations, High-Intensity With Pertubations
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
~99 spots leftby Jun 2027