Clinical trial NCT04110561: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Wandercraft
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: 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.
timeFrame: At study completion, up to 3 weeks
Secondary outcomes:
measure: Capacity of patient in walking defined by Success / Failure on a 10mWT test at the 6th session.
timeFrame: At study mid-term, 10 days in average
measure: The maximum distance walked during the 10mWT at the 6th and 12th sessions.
timeFrame: At study mid-term, 10 days in average and at study completion, up to 3 weeks
measure: The average walking speeds during the 10mWT at the 6th and 12th sessions.
timeFrame: At study mid-term, 10 days in average and at study completion, up to 3 weeks
measure: Capacity of the patient to perform verticalization as defined by the test "Stand-up" at the 6th and 12th sessions.
timeFrame: At study mid-term, 10 days in average and at study completion, up to 3 weeks
measure: Capacity of a standing patient to reach a sitting position as defined by the test "Sit down" at the 6th and 12th sessions.
timeFrame: At study mid-term, 10 days in average and at study completion, up to 3 weeks
measure: Ability of the patient to maintain a stand still position for 2 minutes as defined by the test "Stand without support for 2 minutes" at the 6th and 12th sessions.
timeFrame: At study mid-term, 10 days in average and at study completion, up to 3 weeks
measure: Ability of the patient to lean with extended arm in a standing position (90° arms) at the 6th and 12th sessions.
timeFrame: At study mid-term, 10 days in average and at study completion, up to 3 weeks
measure: Ability of the patient to perform a U-turn in less than 3 minutes as defined by the test "Make a U-turn" at the 6th and 12th sessions.
timeFrame: At study mid-term, 10 days in average and at study completion, up to 3 weeks
measure: Average scores on Borg CR-10 simple perception scale for the perceived exertion at the 6th and 12th sessions.
timeFrame: At study mid-term, 10 days in average and at study completion, up to 3 weeks
measure: Average scores of safety perceived by the patient on a 7-point Likert scale 7 levels at the 6th and 12th sessions.
timeFrame: At study mid-term, 10 days in average and at study completion, up to 3 weeks
measure: Observation of the skin condition was made before and after each session on the subject's back, thighs, knees and feet.
timeFrame: Throughout study completion, an average of 3 weeks
measure: Comparison of the NBD score before the 1st session and after the 12th session.
timeFrame: At study start, day 1 and at study completion, up to 3 weeks
measure: Comparison of the Bristol scale before the 1st session and after the 12th session.
timeFrame: At study start, day 1 and at study completion, up to 3 weeks
measure: Definition of the voiding mode at the 1st and 12th sessions.
timeFrame: At study start, day 1 and at study completion, up to 3 weeks
measure: Qualiveen score at the 1st and 12th sessions.
timeFrame: At study start, day 1 and at study completion, up to 3 weeks
measure: Spasticity according to the Modified Ashworth scale at the 1st and 12th sessions.
timeFrame: At study start, day 1 and at study completion, up to 3 weeks
measure: Heart rate measurement at rest and after the 10mWT at the 1st, 6th and 12th sessions.
timeFrame: At study start, day 1, at study mid-term, 10 days and at study completion, up to 3 weeks
measure: Comparison of the Visual Analogue Pain Scale at the 1st and 12th sessions.
timeFrame: At study start, day 1 and at study completion, up to 3 weeks
measure: Comparison of the NPSI scores at the 1st and 12th sessions.
timeFrame: At study start, day 1 and at study completion, up to 3 weeks
measure: Patient Global Impression of Improvement (PGI-I) at the 12th session.
timeFrame: At study completion, up to 3 weeks
measure: Average scores of the 7-point Likert scale for ergonomics at the 12th session.
timeFrame: At study completion, up to 3 weeks
measure: Time of installation of the patient in the exoskeleton at the 12th session.
timeFrame: At study completion, up to 3 weeks
measure: Assistance level for each fastener at the 12th session.
timeFrame: At study completion, up to 3 weeks
measure: Average scores of the 7-point Likert scale for exoskeleton attachment questionnaire at the 12th session.
timeFrame: At study completion, up to 3 weeks
measure: Evaluation of sitting balance using the Boubee test at the 1st and 12th sessions.
timeFrame: At study start, day 1 and at study completion, up to 3 weeks
measure: Adverse events collection at each session.
timeFrame: Throughout study completion, an average of 3 weeks
Other outcomes:
Locations:
city: Berck
country: France
facility: Centre Jacques Calvé - Fondation Hopale
city: Ploemeur
country: France
facility: Centre mutualiste de Rééducation et de Réadaptation de Kerpape
Study officials:
affiliation: Centre mutualiste de Rééducation et de Réadaptation de Kerpape
name: Jacques Kerdraon, Dr
role: PRINCIPAL_INVESTIGATOR
References: