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

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Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

The primary endpoint of the clinical investigation is defined by the success or failure at the 10 Meter Walk Test (10mWT) at the latest session.

Secondary Outcome

 Capacity of patient in walking defined by Success / Failure on a 10mWT test at the 6th session.

Condition

Spinal Cord Injuries

Intervention

Use of the Atalante exoskeleton

Study Arms / Comparison Groups

 Spinal Cord Injury patients with motor complete paralysis
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

12

Start Date

May 5, 2018

Completion Date

November 16, 2018

Primary Completion Date

November 16, 2018

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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Jacques Kerdraon, Dr, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04110561

Organization ID

TPL005


Responsible Party

Sponsor

Study Sponsor

Wandercraft


Study Sponsor

Jacques Kerdraon, Dr, Principal Investigator, Centre mutualiste de Rééducation et de Réadaptation de Kerpape


Verification Date

October 2019