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 @ 3:26 PM
Ignite Modification Date:
2025-12-24 @ 3:26 PM
NCT ID:
NCT04047992
Eligibility Criteria:
Inclusion Criteria:
1. Traumatic or non-traumatic SCI ≥6 months duration of SCI;
2. Wheelchair-user for indoor and outdoor mobility;
3. Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D);
4. Able to hold the crutches in hands with or without modifications; and
5. Able to provide informed consent.
Exclusion Criteria:
1. Diagnosis of neurological injury other than SCI;
2. Progressive condition that would be expected to result in changing neurological status;
3. Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
4. Anthropocentric incompatibility to be fitted with the device;
5. Traumatic or high impact lower extremity fracture within the past 2 years;
6. Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;
7. Knee BMD \< 0.60 gm/cm2;
8. Total hip BMD T-scores \< -3.5;
9. Untreatable severe spasticity judged to be contraindicated by the Site Physician;
10. Flexion contracture that is incompatible with the device;
11. Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion \> 00);
12. Fracture of the foot by x-ray and confirmed by CT;
13. Untreated or uncontrolled hypertension (systolic blood pressure \>140 mmHg; diastolic blood pressure \>90 mmHg);
14. Unresolved orthostatic hypotension (systolic blood pressure \<90 mmHg; diastolic blood pressure \<60 mmHg) as judged to be contraindicated by the Site Physician;
15. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
16. History of seizure;
17. Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
18. History of stroke, brain tumor, brain abscess, or multiple sclerosis;
19. History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
20. History of implanted brain/spine/nerve simulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
21. Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
22. Pregnancy or women who plan to become pregnant during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04047992
Study Brief:
Protocol Section:
NCT04047992