Actively Recruiting
High-Intensity, Dynamic-stability Gait Training in People With Multiple Sclerosis
Led by Marquette University · Updated on 2024-06-05
150
Participants Needed
2
Research Sites
234 weeks
Total Duration
On this page
Sponsors
M
Marquette University
Lead Sponsor
I
Indiana University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Walking on a shaky treadmill helps to practice balance and intense exercise promotes the ability to walk faster and farther. In this study, participants will train with a combination of high or low intensity, and with a stable or shaky treadmill. Walking speed and endurance, balance while walking and the number of steps taken in the community will be measured before, half way through the training (15 sessions), after training (30 sessions) and six months after training.
CONDITIONS
Official Title
High-Intensity, Dynamic-stability Gait Training in People With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of multiple sclerosis according to revised McDonald Criteria with EDSS score 2.0-6.5
- Stable disease course without worsening more than 1.0 EDSS point over last 3 months and no MS exacerbation within prior 4 weeks
- Stable MS treatments with consistent medications for at least 1 month before enrollment
- No corticosteroids for at least 1 month and no botulinum toxin injections above the knee for at least 3 months before enrollment
- Age between 18 and 65 years and body mass less than 135 kg
- Ability to follow three commands as tested by the Mini Mental State Exam
- No recent myocardial infarction (past month), uncontrolled hypertension (resting BP < 190/110 mmHg), symptomatic blood pressure falls, or uncontrolled diabetes
- Medically stable without severe illnesses limiting exercise, including infections, significant cardiovascular or metabolic disease, osteoporosis, vascular claudication, pitting edema, or pulmonary complications
- Ability to perform walking training with passive range of motion within normal limits
- No concurrent physical therapy or supervised exercise from a trained professional
- No other neurological diseases, epileptic seizures, peripheral nerve injury in lower legs, or traumatic brain injury
- Adequate hearing (whisper test) and vision (minimum 20/80 corrected)
- Ability to walk 10 meters at preferred speed with minimal assistance if needed; use of braces or orthoses allowed
- Not pregnant or planning pregnancy during study due to safety restraints
- Willingness to commit to training schedule, assessments, provide informed consent, and be randomized to any study group
You will not qualify if you...
- Worsening MS symptoms exceeding 1.0 EDSS point in last 3 months or MS exacerbation within prior 4 weeks
- Recent corticosteroid use (within 1 month) or botulinum toxin injections above the knee (within 3 months)
- Age below 18 or above 65 years, or body mass over 135 kg
- Inability to follow three commands on Mini Mental State Exam
- Recent myocardial infarction (within 1 month), uncontrolled hypertension, symptomatic blood pressure falls, or uncontrolled diabetes
- Presence of severe medical illnesses limiting exercise participation
- Concurrent physical therapy or supervised exercise by trained professional
- Other neurological diseases, history of epileptic seizures, peripheral nerve injury in lower legs, or traumatic brain injury
- Inadequate hearing or vision
- Inability to walk 10 meters at preferred speed with minimal assistance
- Pregnancy or planning pregnancy during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46254
Actively Recruiting
2
Marquette University
Milwaukee, Wisconsin, United States, 53233
Actively Recruiting
Research Team
B
Brian D Schmit, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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