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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT04633759
Eligibility Criteria:
Inclusion Criteria:
* Adults ages 18-70
* Neurologist-confirmed diagnosis of multiple sclerosis
* Expanded Disability Status Scale (EDSS) 6.0 to 7.0
* EDSS 6.0: unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting
* EDSS 6.5: Bilateral assistance (cane or crutch) required to walk at least 20 meters with or without resting
* EDSS 7.0: unable to walk 5 meters even with aid, essentially restricted to wheelchair; wheels self and transfers alone; up and about in wheelchair some 12 hours a day
Exclusion Criteria:
* EDSS 7.5 or greater: Restricted to wheelchair for all mobility, unable to walk more than a few steps, even with walking aid
* EDSS 5.5 or less: Able to walk more than 100 meters without walking aid or rest
* Unable to provide consent or follow simple directions
* Prior history of Deep Venous Thrombosis/ Pulmonary Embolism
* History of peripheral vascular disease, thrombophilia or other clotting disorders
* Patient report of easy bruising
* Any comorbid conditions or pain that substantially affects physical function or would interfere with the participant's ability to safely complete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic, or ongoing medical treatments) as determined by a neurologist of physical therapist
* Severe lower extremity spasticity as defined as Modified Ashworth scale \> 2
* Currently undergoing supervised resistance training with a physical therapist or other exercise professional
* Use of Blood Flow Restriction currently or in the previous 3 months prior to enrollment
* MS-related exacerbation or changes to their disease-modifying drug therapy in the month prior to enrollment
* Inability to tolerate pressure cuff during baseline assessment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04633759
Study Brief:
Protocol Section:
NCT04633759