ExoAtlet II For SCI Patients

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Brief Title

ExoAtlet II For SCI Patients

Official Title

ExoAtlet II Lower Extremity Exoskeleton Safety and Efficacy Use With Spinal Cord Injured Individuals

Brief Summary

      This study will evaluate the ExoAtlet II exoskeleton for safety and effectiveness of
      providing persons with a spinal cord injury (SCI) who are non-ambulatory or have limited
      ambulatory function, to stand up and ambulate under a variety of conditions.
    

Detailed Description

      The study will introduce the ExoAtlet II exoskeleton to SCI patients with lower extremity
      paralysis (partial or complete) and provide rehabilitative standing and walking intervention.
      The study will be conducted with a trained clinician that will fit each patient into the
      adjustable exoskeleton system and provide customized programming to meet each user's specific
      needs. The training program will be initiated based upon each patient's comfort in the
      exoskeleton and ability to stand with assistance. Each patient will be closely monitored to
      assess ongoing health as well as their individual standing and walking ability. All
      exoskeleton sessions will be performed with a trained medical professional controlling the
      exoskeleton. Patient safety is the primary concern and all adverse events will be documented
      and addressed. This study will evaluate the ExoAtlet 2.0 exoskeleton for safety and
      effectiveness of providing persons with a spinal cord injury (SCI) who are non-ambulatory or
      have limited ambulatory function, the ability to stand up and walk in a clinical facility.
    


Study Type

Interventional


Primary Outcome

Number of adverse events

Secondary Outcome

 10 Meter Walk Test

Condition

Spinal Cord Injuries

Intervention

Gait training using ExoAtlet exoskeleton

Study Arms / Comparison Groups

 ExoAtlet II Safety and Efficacy
Description:  20 participants with paraplegia from SCI will participate in gait training using ExoAtlet II powered exoskeleton.

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

20

Start Date

November 18, 2019

Completion Date

January 4, 2020

Primary Completion Date

January 4, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. 18 Years of age or older in general good health

          2. Weight, no more than 220lbs (100kg)

          3. Skin must be healthy where it touches the ExoAtlet 2.0

          4. Able to stand using a device such as a standing frame

          5. Have enough strength in your hands and shoulders to support yourself standing and
             walking using crutches or a walker

          6. Have good control of upper body

          7. Determined to have enough bone health to walk full weight bearing without risk of
             fracture. Meeting of this condition is at the discretion of your personal MD

          8. Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower
             extremities within functional limits for safe gait and use of appropriate assistive
             device/stability aid

          9. Hip width no greater than 18" (46 cm) measured when sitting.

         10. Femur length between 37 cm and 49 cm measured between mid patellar tendon and the
             floor.

         11. In general, good health and able to tolerate moderate levels of activity.

         12. Blood pressure and heart rate within established guidelines for locomotive training:
             At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 100 or less
             Exercise; Systolic 180 or less, Diastolic 105 or less and Heart Rate 145 or less

        Exclusion Criteria:

          1. Spinal cord injury level higher than T4 or C7 ASIA D

          2. Severe muscle stiffness/tightness

          3. Significant spasticity (Modified Ashworth Scale score of 3 or above)

          4. Trunk or lower extremity pressure ulcer

          5. Open Wounds/tissue hypersensitivity

          6. Unstable spine, un-healed limbs, or fractures

          7. Severe sensitivity to touch

          8. Presence of bone in soft tissue where bone normally does not exist (heterotopic
             ossification), limiting range of motion in the hip or knee joints

          9. Joint instability, dislocation, moderate to severe hip dysplasia

         10. Significant scoliosis (>40 degrees)

         11. Hardware, implant, or any external device impeding with safe fitting or use of
             ExoAtlet 2.0

         12. Femoral or tibial rotation deformity (>15 degrees)

         13. Significant flexion contractures limited to 35º at the hip and 20º at the knee

         14. Uncontrolled seizures, musculoskeletal injury, fracture or lower-limb surgery in past
             year.

         15. Known history of pulmonary disease limiting exercise tolerance or history of cardiac
             disease

         16. Psychopathology, or other condition that the physician or investigator, in his or her
             clinical judgment, considers to be exclusionary to safely use an exoskeleton.

         17. Severe concurrent medical diseases, illness, systemic or peripheral infection

         18. Dizziness or headache with standing

         19. History of autonomic dysreflexia

         20. Orthostatic Hypotension: Decrease in Systolic BP > 20, Diastolic BP > 10 upon standing
             from a seated position.

         21. Pregnant or lactating females
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sergey Kotov, MD, , 

Location Countries

Russian Federation

Location Countries

Russian Federation

Administrative Informations


NCT ID

NCT04215081

Organization ID

EA22019SCI


Responsible Party

Sponsor

Study Sponsor

ExoAtlet


Study Sponsor

Sergey Kotov, MD, Principal Investigator, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy


Verification Date

January 2020