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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT02118194
Eligibility Criteria:
Inclusion Criteria:
* Males or females with spinal cord injury (SCI) who have already participated in at least 20 ReWalk training sessions.
Exclusion Criteria:
1. Diagnosis of neurological injury other than SCI including: Multiple sclerosis (MS), Stroke, Cerebral Palsy (CP), Amyotrophic lateral sclerosis (ALS), Traumatic Brain injury (TBI), Spina bifida, Parkinson's disease (PD), or other neurological condition that the study physician considers in his/her clinical judgment to be exclusionary;
2. Severe concurrent medical disease, illness or condition;
3. Unhealed fractures;
4. Systemic or peripheral infection;
5. Atherosclerosis, congestive heart failure, or history of myocardial infarction;
6. Trunk and/or lower extremity pressure ulcers;
7. Other illness, that the study physician considers in his/her clinical judgment to be exclusionary;
8. Severe spasticity (defined by an Ashworth score of \>4.0 or clinical impression of the study physician or physical therapist);
9. Significant contractures or heterotropic ossification of the lower extremities that prevent flexion and extension of the joint;
10. Distal femur and/or proximal tibia bone mineral density less than 0.59 cm2.
11. Femoral neck or the total proximal femur bone mineral density T-scores \< -3.5;
12. Psychopathology documentation in the medical record or history of that may conflict with study objectives;
13. Hypertension (Systolic Blood Pressure \>140, Diastolic Blood Pressure \>90); and/or
14. Pregnancy and/or lactating females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02118194
Study Brief:
Protocol Section:
NCT02118194