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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT03343132
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Healthy controls
* Patients with an incomplete spinal cord injury in a chronic (at least 12 months post-injury) or subacute (3-6 months post-injury) stage of recovery
* Age: 18 years and older
* Able to stand without physical assistance and handrails for more than 120s
* preserved segmental and cutaneo-muscular reflexes in the lower limbs
* Bodyweight over 20 kg and under 120 kg
* Mini-Mental state examination score 26 (test only performed if cognitive deficits are suspected)
Exclusion Criteria:
* Current orthopedic problems
* Neurological impairment other than SCI
* Premorbid major depression or psychosis
* Metal implants in the cervical skull
* History of significant autonomic dysreflexia with treatment
* Dermatological issues (e.g. decubitus) at the harness attachment site (back, abdomen, upper legs)
* Malignant diseases
* Heart insufficiency NYHA III-IV
* Potential pregnancy
* Unlikely to complete the intervention or return for follow-up
* Participation in another training study
* Contraindications for training using the GRAIL (according the manual)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03343132
Study Brief:
Protocol Section:
NCT03343132