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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT01943669
Eligibility Criteria:
Inclusion Criteria:
* American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B \& C (Lower Extremity Motor Score \<20)
* Motor level of injury from Cervical level 7 to Lumbar level 1, according to ASIA guidelines
* Male and non-pregnant, non-lactating female
* Age 18-55 years old
* At least 12 months after injury
* Able to stand or maintain upright position with or without using a standing device (e.g., 'Easy stand')
* Able to sit with hips and knees ≥90° flexion
* Height of 160 to 190 cm
* Weight of \<100 kg
Exclusion Criteria:
* History of severe neurological injuries other than spinal cord injury (eg. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
* Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study
* Unstable spine or unhealed limbs or pelvic fractures
* Limited range of motion (\<90°) hip and knee joints, including severe contractures
* Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus
* Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.
* Psychiatric or cognitive conditions that may interfere with the trial
* Previous use of any exoskeletal robotic device
* Patients incapable of providing informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01943669
Study Brief:
Protocol Section:
NCT01943669