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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT04110561
Eligibility Criteria:
Inclusion Criteria:
* Motor complete traumatic Spinal Cord Injury (AIS A and B) since at least 4 months
* Spinal Injury Level between AIS T5 and AIS T12
* Able to verticalize on a daily basis
* Height: between approximately 1.60 and 1.90 m. More specifically, Atalante is able to accommodate the following limb lengths:
* Thigh: 380-460 mm
* Distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with Atalante):
* 457-607 mm for patient with an ankle dorsiflexion ≥ 16°
* 457-577 mm for patient with an ankle dorsiflexion between 13° et 16°
* 457-567 mm for patient with an ankle dorsiflexion between 10° et 13°
* 457-557 mm for patient with an ankle dorsiflexion between 0° et 10° o Hip width less of equal to 460 mm when seated
* Maximum weight: 90 kg
* Patient having given his written consent
Exclusion Criteria:
* Patients whose joint centers cannot be aligned Atalante's
* Ranges of motion below:
* Hip: 115° flexion, 15° extension, 17° abduction, 10° adduction, 10° medial rotation, 20° lateral rotation
* Knee: 5° extension, 110° flexion
* Ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion
* Severe spasticity (greater than 3 on the modified Ashworth scale) of the adductor muscles, hamstrings, quadriceps and triceps surae
* Pregnant or lactating woman
* Unbalanced psychiatric or cognitive status which may interfere with an appropriate use of the device
* Other neurological disorder
* History of osteoporotic fracture and/or disease or treatment responsible for a secondary osteoporosis
* Active implantable medical device
* Evolutive intercurrent disease: pressure sore, infection, venous thrombosis
* Unstable and unhealed limb and pelvic fracture
* Unstable spine
* Severe illness which may interfere with the verticalized posture and tolerance to effort
* Evolutive osteoma
* Syringomyelia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04110561
Study Brief:
Protocol Section:
NCT04110561