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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT02658656
Eligibility Criteria:
Inclusion Criteria:
1. Veterans or active duty military personnel who are at least 18 years of age;
2. Traumatic or non-traumatic SCI 6 months duration of SCI;
3. Wheelchair-user for indoor and outdoor mobility;
4. Anthropometric compatibility with the device:
1. Weight \<220 lb. (100 kg),
2. Thigh length between 14 and 19 in (36 and 48 cm),
3. Shank length between 17 and 22 in (43 and 55 cm);
5. Able to hold the crutches in hands without modifications;
6. Able to have a companion who can attend approximately one-third of the training sessions who will assist them at home and in the community; and
7. 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. Unhealed or unstable traumatic or high impact lower extremity fracture (definition below) of any duration that is in the clinical judgement of the study physician to be exclusionary for standing and walking;
5. Knee BMD \< 0.60 gm/cm2;
6. Total hip BMD T-scores \< -3.5;
7. Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury (definition below);
8. Untreatable severe spasticity judged to be contraindicated by the Site Physician;
9. Flexion contracture \> 15 degrees at the hip and/or \> 10 degrees at the knee;
10. Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion \> 00);
11. Untreated or uncontrolled hypertension (systolic blood pressure \>140 mmHg; diastolic blood pressure \>90 mmHg);
12. Unresolved orthostatic hypotension (systolic blood pressure \<90 mmHg; diastolic blood pressure \<60 mmHg) as judged to be contraindicated by the Site Physician;
13. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
14. Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
15. Pregnancy or women who plan to become pregnant during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02658656
Study Brief:
Protocol Section:
NCT02658656