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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT02774603
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18-65 years
2. Cervical level (C1-C7) SCI of traumatic origin
3. Motor incomplete SCI (ASIA Impairment Scale C or D)
4. Chronic SCI, \>12 months
5. Age between 18 to 65 years
6. Functional Status
i. Overground ambulator (able to walk at least 10 m with or without an assistive device)
ii. Able to demonstrate active movement at/or below L2 myotome
iii. Able to demonstrate adequate head control
1\. Voluntarily extend head while positioned in harness
iv. Tolerance to activity
1\. Participant able to tolerate up to 1 hour of standing without experiencing symptoms of orthostatic hypotension
g. Range of motion
i. PROM values for ankle dorsiflexion
1\. Neutral positioning, 0○
ii. PROM values for knee extension
1\. Up to -10○
iii. PROM values for hip extension
1\. Neutral positioning, 0○
h. Height
i. Participant with minimum height of 48"
i. Weight
i. Participant with minimum weight of (to be determined based on therapist's clinical judgment)
ii. Participant with maximum weight of 300 lb
j. Participants are able to comply with procedures and follow up
k. Participants are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
l. Participants are legally able to make their own health care decisions
Exclusion Criteria:
a. Medical Complications i. Fracture
1\. Participant with presence of unhealed fracture ii. Physician hold for medical reasons that the Principle Investigator will judge and decide on a case by case basis as a potential safety threat to the participant
1. Wounds a. Allowed if physician cleared i. Excluded wounds likely to be present in areas enclosed with harness, present in areas that require access for facilitation, present in areas of direct weight bearing during LT session b. Wounds allowed must be fully covered with gauze then opsite (waterproof bandage) before Aquatic Locomotor Training
2. Comorbidities a. E.g. poorly controlled diabetes, uncontrolled seizures, etc.
3. Orthostatic hypotension
a. Participant demonstrates symptomatic orthostatic hypotension that limits activity
4. Uncontrolled autonomic dysreflexia symptoms a. Episode of uncontrolled autonomic dysreflexia symptoms within the past 1 month iii. Diarrhea iv. Mechanical ventilation v. Pacemakers vi. Central lines vii. Women who are pregnant, confirmed by a urine pregnancy test that will be done on all menstruating, or non-menopausal women viii. History of neurological disease ix. Non English speaking participants will not be targeted b. Currently undergoing, or have received Aquatic Locomotor Training or overground Locomotor Training within four weeks of the study start date (see above in 4d for further details)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02774603
Study Brief:
Protocol Section:
NCT02774603