ExoAtlet II For SCI Patients (EXOATLET2SCI)

July 26, 2023 updated by: ExoAtlet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 129110
        • Moscow Regional Research Clinical Institute. M.F. Vladimirsky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ExoAtlet II Safety and Efficacy
20 participants with paraplegia from SCI will participate in gait training using ExoAtlet II powered exoskeleton.
Device: Gait training using ExoAtlet exoskeleton
Subjects will learn to use the ExoAtlet II exoskeleton, with the assistance of a trained medical professional, to perform functional activities (including stand-up, sit-down, stepping forward, and walking).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 0-8 weeks
Document and track any adverse events, both minor and major, during exoskeleton sessions.
0-8 weeks
Skin integrity
Time Frame: 0-8 weeks
A visual inspection of the participant's skin, at all areas of contact with the exoskeleton, will be conducted at the beginning and end of each session.
0-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 Meter Walk Test
Time Frame: 1 Day
Assesses walking speed, in the exoskeleton, in meters per second over a distance of 10 meters
1 Day
6 Minute Walk Test
Time Frame: 1 Day
Record the distance covered during a 6 minute walk test utilizing the exoskeleton, to evaluate users endurance
1 Day
Transfer in and out
Time Frame: 2 Days
Percentage of patients able to successfully transfer in and out of the exoskeleton with or without assistance
2 Days
Perform Sit to Stand to Sit
Time Frame: 2 Days
Percentage of patients that successfully completed both sit to stand and stand to sit in the exoskeleton
2 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ExoAtlet

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Actual)

January 4, 2020

Study Completion (Actual)

January 4, 2020

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

December 28, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA22019SCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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