Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT03963492
Eligibility Criteria:
Inclusion Criteria:
* Self-identified difficulty walking
* Definitive diagnosis of multiple sclerosis from a neurologist
* Signed an approved consent form
* Ability to ambulate for unaided for 6-minutes continuously with or without an assistive device (e.g. a cane or brace)
* Has not had a multiple sclerosis relapse in the past 6 weeks
Exclusion Criteria:
* Unwilling or unable to complete assessments
* Unwilling or able to complete assessments and or intervention without the use of portable functional electrical stimulation devices
* Medical history of concomitant condition unrelated to multiple sclerosis which may impact results including: other neurological conditions including stroke, Parkinson's disease, or orthopedic, or cardiopulmonary conditions that affect walking
* Had a major change in exercise habits in the past three months
* Individuals reporting change in any disease modifying treatment or steroid use during the past 6 weeks
* Unable to walk for 6 minutes continuously without physical assistance
* Medical history of unstable angina, uncontrolled cardiac dysrhythmias causing symptoms, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, history of deep vein thrombosis, acute myocarditis or pericarditis, acute systemic infection, uncontrolled hypertension, and uncontrolled diabetes
* Has an abnormal response to exercise
* Cannot adhere to protocol
* Determined to be unsafe at the discretion of the research team including individuals unwilling to wear safety "gait belt" during testing or not willing to wear proper footwear.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03963492
Study Brief:
Protocol Section:
NCT03963492