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New treatment option for Multiple Sclerosis
Official title High-Intensity, Dynamic-stability Gait Training in People With Multiple Sclerosis
ClinicalTrials.gov ID: NCT05735691
What this study is testing
- What it's testing
- The goal of this clinical trial is to improve walking speed, balance, and walking in the community for people with multiple sclerosis. This trial involves intense exercise combined with walking on a shaky treadmill.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Participants will have stable MS disease treatments. All medications will be consistent for at least 1 month prior to enrollment. No corticosteroids...
- Participants will be between the age of 18 and 65 and have a body mass of less than 135kg (maximum mass for treadmill equipment).
- Participants will be able to follow three commands, as determined by the three step command test of the Mini Mental State Exam.
- Participants must have had no myocardial infarction in the past month, must not have uncontrolled hypertension (blood pressure must be \< 190/110...
You likely can't join if
- See inclusion criteria.
See the full eligibility criteria
- 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...
- 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...
- Participants will be between the age of 18 and 65 and have a body mass of less than 135kg (maximum mass for treadmill equipment).
- Participants will be able to follow three commands, as determined by the three step command test of the Mini Mental State Exam.
- 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...
- 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...
- 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 +/-...
- 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...
- Participants must have no other concomitant neurological diseases, no history of epileptic seizures, peripheral nerve injury in lower legs or traumatic brain injury.
- Participants must have adequate hearing (whisper test) and vision (minimum 20/80 corrected vision on a Snellen chart).
- 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...
- 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...
- 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 assigned by chance to...
- See inclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.