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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT05187650
Eligibility Criteria:
Inclusion Criteria:
* chronic, incomplete SCI (\> 1 year, AIS B-D)
* traumatic or non-traumatic lesion
* capacity to stand up and perform a 10MWT with or without medical aids
* partially wheelchair dependent
* intact lower motoneuron on the segmental innervation level of M. glutaeus maximus, Mm. ischiocrurales, M. tibialis anterior and M. quadriceps (to guarantee the stimulability with FES)
Exclusion Criteria:
* Exoskeleton device related contraindications: \> 100 kg body weight; Body height: \< 155 cm or \> 190 cm; pelvic width: \> 46 cm
* orthopedic limitations (acute fractures of the lower limb)
* contractures
* heterotrophic ossification
* spasticity (modified Ashworth Scale \>3)
* skin injuries of the lower limbs in areas where the skin has contact with the exoskeleton
* Unstable circulation (unable to stand for at least 10 minutes)
* acute deep vein thrombosis
* pregnancy (tested in women of childbearing age (15 - 49 years))
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05187650
Study Brief:
Protocol Section:
NCT05187650