NCT05735691 · Marquette University
High-Intensity, Dynamic-stability Gait Training in People With Multiple Sclerosis
What this study 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.
View original scientific description
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.
Interventions
PROCEDURE
High-Intensity Treadmill Training
Participants will walk on a treadmill at a speed that produces 70-80% of age-adjusted heart rate reserve or a rating of perceived exertion of 17/20. A total of 30, one hour sessions will be conducted. Training will be conducted in 10 minute bouts, with 2-3 minutes rest between bouts.
PROCEDURE
Treadmill Training with Perturbations
Participants will walk on a treadmill and a perturbation of the treadmill will be produced every 20s. Perturbations will randomly occur in the forward, backward, right or left directions, with a perturbation size set to 80% of stability threshold. A total of 30, one hour sessions will be conducted. Training will be conducted in 10 minute bouts with 2-3 minutes rest between bouts.
PROCEDURE
Standard Treadmill Training
Participants will walk on a treadmill at a speed that produces 30-40% of age-adjusted heart rate reserve. A total of 30, one hour sessions will be conducted. Training will be conducted in 10 minute bouts, with 2-3 minutes rest between bouts.
Primary outcome measures
Changes in Timed 25-foot walk test
Time frame: Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
Gait speed will be measured using the timed 25-foot walk test. The test consists of walking 25 feet along a clearly marked walkway as quickly as possible while maintaining safety, using devices as needed. The task is repeated as the patient walks back the same distance. The average of the two trials is used as a measure of gait speed.
Changes in 6-minute walk test
Time frame: Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
The 6 minute walk test consists of a measurement of the distance walked in 6 minutes, using a walkway of at least 12 meters, with cones demarcating the turnaround points and instructions to walk as fast and as far as possible.
Changes in Functional Gait Assessment (FGA)
Time frame: Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
The FGA measures dynamic balance during walking using a series of 10 tasks, with each item rated on a scale of 0-3 (maximum score = 30). Test components include walking on a level surface at normal pace with changes in gait speed, head turns, obstacle and narrow path negotiation, and on stairs.
Changes in Daily stepping activity
Time frame: Before training, 1-2 weeks after all training sessions, 6 months after all training sessions
Daily stepping activity will be obtained using the StepWatch (Modus, Washington DC), which is an ankle-worn accelerometer that has demonstrated the best accuracy of all commercial accelerometers. Data are collected in 1 min increments with daily stepping activity as the primary variable. Data will be collected for 7 days at each evaluation period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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 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.
- 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.
- 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 standing and must not have documented, uncontrolled diabetes.
- 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.
- 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.
- 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.
- 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 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.
- 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.
- 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
- Indianapolis, Indiana
- Milwaukee, Wisconsin
Collaborators
Indiana University, Medical College of Wisconsin, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2024 · Source of record for eligibility and locations