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 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT03340792
Eligibility Criteria:
Inclusion Criteria:
1. Between the age of 20-65 years old;
2. Have paraplegia resulting from thoracic or lumbar spinal cord injury.
3. At least 6 months after onset of the spinal cord injury
4. Well motivated and willing to participate 40 hours of ReWalk ambulation training sessions.
Exclusion Criteria:
1. Have spinal cord injury neurologic level above T4
2. Height greater than 190 cm or lower than160 cm
3. Weight greater than 100 kg
4. Have osteoporosis (T-score \< -2.5)
5. Deep vein thrombosis
6. Severe orthostatic hypotension precluding standing and walking training
7. Pregnancy
8. Cognitive impairments that would impact on the safe participation in the study
9. Severe spasticity of lower limbs (Modified Ashworth Scale \>3)
10. Contracture of the ankle, or a knee flexion contracture greater than 10 degrees
11. Musculoskeletal conditions that affected gait capacity
12. Co-existence of other neurological diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT03340792
Study Brief:
Protocol Section:
NCT03340792