Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis

Wandercraft

Status: Completed

Conditions: Robotics; Lower Extremity; Spinal Cord Injuries; Paralysis, Lower Limbs; Paraplegia

Treatments: Device: Use of the Atalante exoskeleton

Study type: Interventional

Funder types: Industry

Identifiers

NCT04110561

TPL005

Details and patient eligibility

About

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.

The principal objective is to assess the performance of the Atalante system in performing ambulatory functions with motor complete SCI patients characterized by the success rate in performing a 10mWT at the last session of training with the Atalante system.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Spinal Cord Injury patients with motor complete paralysis

Other group

Treatment:

Device: Use of the Atalante exoskeleton