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 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT02127606
Eligibility Criteria:
Inclusion Criteria:
* The subject is male or female, 18 to 70 years of age, inclusive.
* The subject has neurological impairment secondary to a spinal cord injury that occurred at least six (6) months prior to the study that can be categorized as either a complete or incomplete spinal cord injury.
* The neurological level of lesion is above T10.
* The subject has self-reported stable moderate to severe spasticity (Modified Ashworth Score scale at or greater than a 2 at the hips or knees). Patients can be enrolled if on a stable dose of oral medications or intrathecal medications.
* The subject has self reported spasticity that negatively impacts his or her quality of life, impairs ability to perform activities of daily living (such as transfers, sitting, sleep, wheelchair use, and hobbies).
* The subject is able to stand with the assistance of a tilt table at a minimum of 70 degrees for 45 minutes without significant orthostasis or other adverse events or symptoms.
* The subject is able and willing to comply with the protocol.
* The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.
Exclusion Criteria:
* The subject does not self report lower limb spasticity.
* The subject does not have self reported spasticity that negatively impacts his or her quality of life, impairs ability to perform activities of daily living (such as transfers, sitting, sleep, wheelchair use, and hobbies).
* The subject experiences symptoms consistent with infection, including but not limited to fever, chills, dysuria, gallbladder or kidney stones.
* The subject experiences pain that is not well controlled with consistent pain medication use.
* The subject has recent thromboembolism, diabetes mellitus, intractable hypertension or cardiac/pulmonary instability, internal fixation implants, acute thrombosis, pregnancy, acute inflammation of the locomotor system including active arthrosis or arthropathy, acute tendinopathy, acute hernia, acute discopathy, recent post-surgical wounds, epilepsy, rheumatoid arthritis, or recent fractures\<6 months.
* The subject has a lumbar spinal hardware or artificial joints in the lower extremities.
* The subject is participating in any experimental studies that could alter the patient's spasticity.
* The subject has a concomitant brain injury or other cognitive deficits that would preclude following instructions.
* The subject has skin breakdown in areas receiving direct pressure during tilt table standing.
* The subject has any medical condition, including psychiatric disease that would interfere with the interpretation of the study results or the conduct of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02127606
Study Brief:
Protocol Section:
NCT02127606