Status:
COMPLETED
Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis
Lead Sponsor:
Wandercraft
Conditions:
Spinal Cord Injuries
Paraplegia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The study is a prospective, open, bicentric and observational study. It is conducted to assess the safety and performance of the Atalante exoskeleton system with patients with lower limb paralysis. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04110561
Start Date
May 5 2018
End Date
November 16 2018
Last Update
October 7 2019
Active Locations (2)
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1
Centre Jacques Calvé - Fondation Hopale
Berck, France, 62600
2
Centre mutualiste de Rééducation et de Réadaptation de Kerpape
Ploemeur, France, 56270