High-Intensity, Dynamic-stability Gait Training in People With Multiple Sclerosis
2 other identifiers
interventional
150
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Jan 2023
Longer than P75 for not_applicable multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
June 5, 2024
June 1, 2024
4.5 years
January 11, 2023
June 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in Timed 25-foot walk test
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.
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
Changes in 6-minute walk test
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.
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
Changes in Functional Gait Assessment (FGA)
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.
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
Changes in Daily stepping activity
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.
Before training, 1-2 weeks after all training sessions, 6 months after all training sessions
Secondary Outcomes (9)
Changes in Peak treadmill speed and cardiorespiratory fitness
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
Changes in Berg Balance Scale
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
Changes in Falls incidence
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
Changes in Kinematic Response to unexpected perturbations
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
Changes in Activities-specific Balance Confidence (ABC) score
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions
- +4 more secondary outcomes
Study Arms (4)
High-Intensity With Pertubations
EXPERIMENTAL30 sessions of high-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.
High-Intensity No Perturbations
EXPERIMENTAL30 sessions of high-intensity treadmill training will be conducted on a stable treadmill.
Moderate-Intensity With Perturbations
EXPERIMENTAL30 sessions of moderate-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.
Moderate-Intensity No Perturbations
ACTIVE COMPARATOR30 sessions of moderate-intensity treadmill training will be conducted on a stable treadmill.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marquette Universitylead
- Indiana Universitycollaborator
- Medical College of Wisconsincollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (2)
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254, United States
Marquette University
Milwaukee, Wisconsin, 53233, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian D Schmit, PhD
Marquette University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Assessment will be done by a separate team from the trainers. The participant cannot be blinded as they will recognize the intensity of the exercise and whether the treadmill moves.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2023
First Posted
February 21, 2023
Study Start
January 1, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
June 5, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The investigators will deposit phenotypic outcome data into clinicaltrials.gov, as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier.
- Access Criteria
- Data will be shared through clinicaltrials.gov with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes.
The investigators will share phenotypic data associated with the collected samples by depositing data at clinicaltrials.gov. Additional data documentation and de-identified data will be deposited for sharing along with phenotypic data. Meta-analysis data and associated phenotypic data, along with data content, format, and organization, will be available via contact of the PI (brian.schmit@marquette.edu). We will identify where the data will be available and how to access the data in any publications and presentations that we author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations.