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

NCT ID: NCT04110561

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-05
• Study Completion Date: 2018-11-16

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Spinal Cord Injury patients with motor complete paralysis

Group Type: OTHER

Use of the Atalante exoskeleton

Intervention Type: DEVICE

A session basically includes a stand up, walks over a distance of 10 meters, exercises, U-turns and a sitting

Interventions

Use of the Atalante exoskeleton

A session basically includes a stand up, walks over a distance of 10 meters, exercises, U-turns and a sitting

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wandercraft

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Kerdraon, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre mutualiste de Rééducation et de Réadaptation de Kerpape

Locations

Centre Jacques Calvé - Fondation Hopale

Berck, , France

Centre mutualiste de Rééducation et de Réadaptation de Kerpape

Ploemeur, , France

Countries

France

Other Identifiers

TPL005

Identifier Type: -

Identifier Source: org_study_id