Recruiting

Gait Training

Sponsor:

Marquette University

Code:

NCT05735691

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

High-Intensity Treadmill Training

Treadmill Training with Perturbations

Standard Treadmill Training

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT05735691

Start date

Jan 1, 2023

Status verified date

Jun, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High-Intensity With Pertubations

30 sessions of high-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.

experimental: High-Intensity No Perturbations

30 sessions of high-intensity treadmill training will be conducted on a stable treadmill.

experimental: Moderate-Intensity With Perturbations

30 sessions of moderate-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.

active comparator: Moderate-Intensity No Perturbations

30 sessions of moderate-intensity treadmill training will be conducted on a stable treadmill.

Interventions

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.

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.

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 measure

  • 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 ]
  • 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 ]
  • 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 ]
  • Changes in Daily stepping activity [ Time Frame: Before training, 1-2 weeks after all training sessions, 6 months after all training sessions ]

Central Contacts and Locations

Central contacts

Locations

Rehabilitation Hospital of Indiana

Recruiting

Indianapolis, Indiana, United States, 46254

Contacts

Thomas G Hornby, PhD

tghornby@iu.edu

Marquette University

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

More Information

Sponsor

Marquette University

Last update posted

Jun 5, 2024

Last verified

Jun, 2024

Keywords

  • Walking
  • Balance
  • Treadmill
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Marquette University on 2024-06-05.