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

NCT04110561 | Completed

• 1 other identifier: TPL005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Keywords

Spinal Cord Injuries; Paraplegia; Paralysis, Lower Limbs; Lower Extremity; Robotics; Physiotherapy; Rehabilitation; Powered Exoskeleton; Walking; Ambulation

Outcome Measures

Primary Outcomes (1)

• 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.

  The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. A clear pathway of at least 10-meter length is drawn. The start and the end point of a 10-m walkway is marked by lines. The patient starts a few steps prior the starting line; during the few steps needed to reach the starting line, the physiotherapist should stabilize the exoskeleton in the frontal plane. When the patient's first foot crosses the starting line, the test begins, and the stopwatch is started. The stopwatch is stopped at the end of the 10 meters in case of success, that is to say when the patient crosses the end line. The total time taken to ambulate is recorded. The distance covered is then divided by the total time (in seconds) taken to ambulate and recorded in meters per seconds. In case of failure, the distance walked by the patient is measured and recorded, and the speed to walk this distance is calculated as described above.

  At study completion, up to 3 weeks

Secondary Outcomes (26)

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

  At study mid-term, 10 days in average

• The maximum distance walked during the 10mWT at the 6th and 12th sessions.

  At study mid-term, 10 days in average and at study completion, up to 3 weeks

• The average walking speeds during the 10mWT at the 6th and 12th sessions.

  At study mid-term, 10 days in average and at study completion, up to 3 weeks

• Capacity of the patient to perform verticalization as defined by the test "Stand-up" at the 6th and 12th sessions.

  At study mid-term, 10 days in average and at study completion, up to 3 weeks

• Capacity of a standing patient to reach a sitting position as defined by the test "Sit down" at the 6th and 12th sessions.

  At study mid-term, 10 days in average and at study completion, up to 3 weeks

Study Arms (1)

Spinal Cord Injury patients with motor complete paralysis

OTHER

Device: Use of the Atalante exoskeleton

Interventions

Use of the Atalante exoskeleton DEVICE

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

Spinal Cord Injury patients with motor complete paralysis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• mm for patient with an ankle dorsiflexion ≥ 16°
• mm for patient with an ankle dorsiflexion between 13° et 16°
• mm for patient with an ankle dorsiflexion between 10° et 13°
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wandercraft: lead

Study Sites (2)

Centre Jacques Calvé - Fondation Hopale

Berck, 62600, France

Location

Centre mutualiste de Rééducation et de Réadaptation de Kerpape

Ploemeur, 56270, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacques Kerdraon, Dr

  Centre mutualiste de Rééducation et de Réadaptation de Kerpape

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 1, 2019
• Study Start: May 5, 2018
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)