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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT03186612
Eligibility Criteria:
Inclusion Criteria:
* a diagnosis of MS according to the McDonald criteria with over two years evolution;
* a score of between 3.5 (moderate incapacity, although totally ambulant and able to be self-sufficient and active during 12 hours of a day) and six (requires constant help, either unilateral or intermittently with a walking stick or crutches, in order to walk approximately 100 meters with, or without, a rest) on the Kurtzke Expanded Disability Status Score (EDSS) with;
* stable medical treatment during, at least the six months prior to the intervention;
* muscle tone in the upper limbs not greater than two points on the modified Ashworth Scale (moderate hypertonia, increased muscle tone through most of the range of movement, but affected part easily moved);
* as well as a score of four points or less in the "Pyramidal Function" section of the EDSS functional scale;
* absence of cognitive decline; with the ability to understand instructions and obtaining a score of 24 or more in the Minimental Test;
* as well as a score of two points or less in the "Mental Functions" section of the EDSS.
Exclusion Criteria:
* the diagnosis of another neurological illness or musculoskeletal alteration different to MS;
* the diagnosis of a cardiovascular, respiratory or metabolic illness, or other conditions which may interfere with the study;
* suffering a flare-up or hospitalization in the last three months prior to commencement of the assessment protocol, or during the process of the therapeutic intervention;
* receiving a cycle of steroids, either intravenously or oral, six months prior to the commencement of the assessment protocol and within the study period of intervention;
* receiving treatment with botulinum toxin in the six months prior to the beginning of the study; or the presence of visual disorders non-corrected by optical devices.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03186612
Study Brief:
Protocol Section:
NCT03186612