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 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT02252666
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be age 18 or older.
* Subjects will have a score between 6.5 to 7.5 on the Kurtzke Expanded Disability Status Scale (EDSS). The EDSS is a method of quantifying disability in people with multiple sclerosis.
* Score of 6.5: needs constant bilateral support to walk 20 meters without resting.
* Score of 7.0: unable to walk beyond five meters even with aid, and is essentially restricted to a wheelchair; wheels self and transfers alone, and is active in wheelchair about 12 hours a day.
* Score of 7.5: unable to take more than a few steps and is restricted to wheelchair, and may need aid to transfer; wheels self, but may require a motorized chair for a full day's activities.
* Subjects will have reached a plateau in an MS focused physical rehabilitation program in the 6 months prior to enrollment.
* Requiring prior physical therapy will ensure that subjects have a core level of function that will allow them to participate in the study.
* Requiring that subjects have reached a plateau will ensure that subjects' response to the intervention is due to the use of the device and not to the physical exercises alone.
* Subjects who have participated in a physical rehabilitation program demonstrate that they are willing and able to commit to a rigorous training regimen.
* Subjects will have a maximum score of 20 on the Trunk Impairment Scale (TIS). The TIS assesses static dynamic sitting balance and trunk coordination in a sitting position. A score of 20 or lower indicates that their ability to adequately maintain sitting posture is affected.
* Subjects may have upper extremity involvement.
* Subjects may have additional symptoms of nystagmus, dysarthria, sensory disturbance, pain, and/or bowel and bladder function. As they present, we will use appropriate assessments at baseline and successive study test points.
* Subjects are their own legal guardians, and are able to understand and give informed consent.
Exclusion Criteria:
Subjects will have no major co-morbidities, especially neurological disorders, uncontrolled pain, hypertension or diabetes. All subjects, if on medications, will not have had any major changes in type or dosage in within 3 months of enrollment. Additionally, candidates will be excluded if they:
* have Functional Systems Scores (FSS) 4 or greater for pyramidal, cerebellar, brainstem, and sensory functions; 3 or greater for bowel and bladder function; and 2 or greater for cerebral function;
* are able to walk independently;
* use tobacco products (these activities tend to reduce tactile sensitivity in the oral cavity);
* have any oral abrasions, cuts, cold sores, piercings, tissue inflammation, or have had oral surgery within the previous 3 months;
* have a pacemaker, or are identified as at-risk for cardiovascular events;
* have a history of seizures;
* have a communicable disease;
* have a biomechanical prosthetic;
* are females who are pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02252666
Study Brief:
Protocol Section:
NCT02252666