Phase
Condition
Multiple Sclerosis
Neurologic Disorders
Memory Loss
Treatment
High-Intensity Treadmill Training
Treadmill Training with Perturbations
Standard Treadmill Training
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a clinical diagnosis of MS according to the revised McDonaldCriteria. Participants with an EDSS score of 2.0-6.5 will be included but must havea stable disease course without worsening more than 1.0 EDSS point over the last 3months and no MS exacerbation within the preceding 4 weeks, as determined byinterview and review of medical records.
Participants will have stable MS disease treatments. All medications will beconsistent 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 priorto 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 stepcommand test of the Mini Mental State Exam.
Participants must have had no myocardial infarction in the past month, must not haveuncontrolled hypertension (blood pressure must be < 190/110 mmHg at rest), must nothave a symptomatic fall in blood pressure when standing and must not havedocumented, uncontrolled diabetes.
Participants will be medically stable, with absence of concurrent severe medicalillness including: existing infection, known significant cardiovascular or metabolicdisease that limits exercise participation, significant osteoporosis (as indicatedby known history of fractures), known history of vascular claudication or pittingedema, 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 ofmotion within the limits of normal locomotor function, including: 0-30 +/- 10degrees ankle plantarflexion, knee flexion from 0 to 90 +/- 10 degrees, hip flexionto 0-90 +/- 10 degrees.
Individuals who are undergoing concurrent physical therapy or supervised exercise bya trained professional will be excluded from the study to eliminate confoundingeffects of additional physical interventions. Other therapies, such as occupationalor speech therapies, will be allowed as prescribed by their physician. Individualswill be allowed and encouraged to continue their normal exercise routines during thecourse of the intervention.
Participants must have no other concomitant neurological diseases, no history ofepileptic seizures, peripheral nerve injury in lower legs or traumatic brain injury.
Participants must have adequate hearing (whisper test) and vision (minimum 20/80corrected 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, minimalassistance will be provided to enable training until participants recover enoughthat they are not needed. The use of braces or orthoses is allowed in the proposedstudy to assure orthopedic safety. Participants will be excluded if they havefactors that preclude stepping exercise, such as severe spasticity, excessivefatigue or exercise intolerance.
Women of childbearing potential will not be excluded, although women who arepregnant or who are considering becoming pregnant will be excluded due to the trunkand pelvis restraints required for safety during treadmill training.
Participants must be willing to commit to the treadmill training program scheduleand participate in all of the assessments. They must be able to provide informedwritten consent and willing to be randomized to any of the 4 study arms.
Exclusion
Exclusion Criteria:
See inclusion criteria.
Study Design
Study Description
Connect with a study center
Rehabilitation Hospital of Indiana
Indianapolis, Indiana 46254
United StatesActive - Recruiting
Marquette University
Milwaukee, Wisconsin 53233
United StatesActive - Recruiting
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