High-intensity treadmill training for improving walking in people with multiple sclerosis

High-Intensity, Dynamic-stability Gait Training in People With Multiple Sclerosis

This study is testing whether high-intensity treadmill training can help people with multiple sclerosis walk better and improve their balance and mobility.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Marquette University (Academic / other)
• Locations: 2 sites (Indianapolis, Indiana and 1 other locations)
• Trial ID: NCT05735691 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to enhance walking speed, balance, and community mobility in individuals with multiple sclerosis (MS) through high-intensity treadmill training combined with balance perturbations. Participants will be randomly assigned to one of four groups, varying in exercise intensity and treadmill stability, to assess the effects on their walking abilities. The study will measure outcomes such as walking speed, endurance, and balance before, during, and after the training sessions. The trial is designed to build on previous research indicating that high-intensity training can significantly benefit individuals with mobility impairments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a clinical diagnosis of multiple sclerosis and an EDSS score between 2.0 and 6.5.

Not a fit: Patients with severe MS symptoms or those unable to follow simple commands may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved mobility and quality of life for patients with multiple sclerosis.

How similar studies have performed: Previous studies have shown significant benefits of high-intensity treadmill training in similar populations, suggesting a promising approach.

Eligibility criteria

Inclusion Criteria:

1. Participants must have a clinical diagnosis of MS according to the revised McDonald Criteria. Participants with an EDSS score of 2.0-6.5 will be included but must have a stable disease course without worsening more than 1.0 EDSS point over the last 3 months and no MS exacerbation within the preceding 4 weeks, as determined by interview and review of medical records.
2. Participants will have stable MS disease treatments. All medications will be consistent for at least 1 month prior to enrollment. No corticosteroids for at least 1 month and no botulinum toxin injections above the knee for at least 3 months prior to enrollment.
3. Participants will be between the age of 18 and 65 and have a body mass of less than 135kg (maximum mass for treadmill equipment).
4. Participants will be able to follow three commands, as determined by the three step command test of the Mini Mental State Exam.
5. Participants must have had no myocardial infarction in the past month, must not have uncontrolled hypertension (blood pressure must be \< 190/110 mmHg at rest), must not have a symptomatic fall in blood pressure when standing and must not have documented, uncontrolled diabetes.
6. Participants will be medically stable, with absence of concurrent severe medical illness including: existing infection, known significant cardiovascular or metabolic disease that limits exercise participation, significant osteoporosis (as indicated by known history of fractures), known history of vascular claudication or pitting edema, and known history of pulmonary complications that limits exercise capacity, including significant obstructive and/or restrictive lung diseases.
7. All participants must be able to perform walking training with passive range of motion within the limits of normal locomotor function, including: 0-30 +/- 10 degrees ankle plantarflexion, knee flexion from 0 to 90 +/- 10 degrees, hip flexion to 0-90 +/- 10 degrees.
8. Individuals who are undergoing concurrent physical therapy or supervised exercise by a trained professional will be excluded from the study to eliminate confounding effects of additional physical interventions. Other therapies, such as occupational or speech therapies, will be allowed as prescribed by their physician. Individuals will be allowed and encouraged to continue their normal exercise routines during the course of the intervention.
9. Participants must have no other concomitant neurological diseases, no history of epileptic seizures, peripheral nerve injury in lower legs or traumatic brain injury.
10. Participants must have adequate hearing (whisper test) and vision (minimum 20/80 corrected vision on a Snellen chart).
11. Participants must be able to walk for 10 meters at their preferred walking speed. For participants that require assistive devices to walk overground, minimal assistance will be provided to enable training until participants recover enough that they are not needed. The use of braces or orthoses is allowed in the proposed study to assure orthopedic safety. Participants will be excluded if they have factors that preclude stepping exercise, such as severe spasticity, excessive fatigue or exercise intolerance.
12. Women of childbearing potential will not be excluded, although women who are pregnant or who are considering becoming pregnant will be excluded due to the trunk and pelvis restraints required for safety during treadmill training.
13. Participants must be willing to commit to the treadmill training program schedule and participate in all of the assessments. They must be able to provide informed written consent and willing to be randomized to any of the 4 study arms.

Exclusion Criteria:

See inclusion criteria.

Where this trial is running

Indianapolis, Indiana and 1 other locations

• Rehabilitation Hospital of Indiana — Indianapolis, Indiana, United States (Recruiting)
• Marquette University — Milwaukee, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Brian D Schmit, PhD — Marquette University
• Study coordinator: Brian D Schmit, PhD

Conditions Multiple Sclerosis; Walking; Balance; Treadmill; Exercise