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ExoAtlet II For SCI Patients (EXOATLET2SCI)

Primary Purpose

Spinal Cord Injuries, Paraplegia

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Gait training using ExoAtlet exoskeleton
Sponsored by
ExoAtlet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moscow Regional Research Clinical Institute. M.F. Vladimirsky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ExoAtlet II Safety and Efficacy

Arm Description

20 participants with paraplegia from SCI will participate in gait training using ExoAtlet II powered exoskeleton.

Outcomes

Primary Outcome Measures

Number of adverse events
Document and track any adverse events, both minor and major, during exoskeleton sessions.
Skin integrity
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2019
Last Updated
July 26, 2023
Sponsor
ExoAtlet
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1. Study Identification

Unique Protocol Identification Number
NCT04215081
Brief Title
ExoAtlet II For SCI Patients
Acronym
EXOATLET2SCI
Official Title
ExoAtlet II Lower Extremity Exoskeleton Safety and Efficacy Use With Spinal Cord Injured Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
January 4, 2020 (Actual)
Study Completion Date
January 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ExoAtlet

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Paraplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
SCI Level T4-L5 or, C7-T3 with ASIA D
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ExoAtlet II Safety and Efficacy
Arm Type
Experimental
Arm Description
20 participants with paraplegia from SCI will participate in gait training using ExoAtlet II powered exoskeleton.
Intervention Type
Device
Intervention Name(s)
Gait training using ExoAtlet exoskeleton
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of adverse events
Description
Document and track any adverse events, both minor and major, during exoskeleton sessions.
Time Frame
0-8 weeks
Title
Skin integrity
Description
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.
Time Frame
0-8 weeks
Secondary Outcome Measure Information:
Title
10 Meter Walk Test
Description
Assesses walking speed, in the exoskeleton, in meters per second over a distance of 10 meters
Time Frame
1 Day
Title
6 Minute Walk Test
Description
Record the distance covered during a 6 minute walk test utilizing the exoskeleton, to evaluate users endurance
Time Frame
1 Day
Title
Transfer in and out
Description
Percentage of patients able to successfully transfer in and out of the exoskeleton with or without assistance
Time Frame
2 Days
Title
Perform Sit to Stand to Sit
Description
Percentage of patients that successfully completed both sit to stand and stand to sit in the exoskeleton
Time Frame
2 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 Years of age or older in general good health Weight, no more than 220lbs (100kg) Skin must be healthy where it touches the ExoAtlet 2.0 Able to stand using a device such as a standing frame Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker Have good control of upper body 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 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 Hip width no greater than 18" (46 cm) measured when sitting. Femur length between 37 cm and 49 cm measured between mid patellar tendon and the floor. In general, good health and able to tolerate moderate levels of activity. 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: Spinal cord injury level higher than T4 or C7 ASIA D Severe muscle stiffness/tightness Significant spasticity (Modified Ashworth Scale score of 3 or above) Trunk or lower extremity pressure ulcer Open Wounds/tissue hypersensitivity Unstable spine, un-healed limbs, or fractures Severe sensitivity to touch Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints Joint instability, dislocation, moderate to severe hip dysplasia Significant scoliosis (>40 degrees) Hardware, implant, or any external device impeding with safe fitting or use of ExoAtlet 2.0 Femoral or tibial rotation deformity (>15 degrees) Significant flexion contractures limited to 35º at the hip and 20º at the knee Uncontrolled seizures, musculoskeletal injury, fracture or lower-limb surgery in past year. Known history of pulmonary disease limiting exercise tolerance or history of cardiac disease Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton. Severe concurrent medical diseases, illness, systemic or peripheral infection Dizziness or headache with standing History of autonomic dysreflexia Orthostatic Hypotension: Decrease in Systolic BP > 20, Diastolic BP > 10 upon standing from a seated position. Pregnant or lactating females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey Kotov, MD
Organizational Affiliation
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moscow Regional Research Clinical Institute. M.F. Vladimirsky
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28865396
Citation
Gagnon DH, Cunha JD, Boyer-Delestre M, Bosquet L, Duclos C. How does wearable robotic exoskeleton affect overground walking performance measured with the 10-m and six-minute walk tests after a basic locomotor training in healthy individuals? Gait Posture. 2017 Oct;58:340-345. doi: 10.1016/j.gaitpost.2017.08.027. Epub 2017 Aug 26.
Results Reference
background
PubMed Identifier
27042146
Citation
Miller LE, Zimmermann AK, Herbert WG. Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. Med Devices (Auckl). 2016 Mar 22;9:455-66. doi: 10.2147/MDER.S103102. eCollection 2016.
Results Reference
background
PubMed Identifier
29434463
Citation
Tefertiller C, Hays K, Jones J, Jayaraman A, Hartigan C, Bushnik T, Forrest GF. Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018 Winter;24(1):78-85. doi: 10.1310/sci17-00014. Epub 2017 Nov 20.
Results Reference
background
PubMed Identifier
26364278
Citation
Hartigan C, Kandilakis C, Dalley S, Clausen M, Wilson E, Morrison S, Etheridge S, Farris R. Mobility Outcomes Following Five Training Sessions with a Powered Exoskeleton. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):93-9. doi: 10.1310/sci2102-93. Epub 2015 Apr 12.
Results Reference
background
PubMed Identifier
26364280
Citation
Kozlowski AJ, Bryce TN, Dijkers MP. Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):110-21. doi: 10.1310/sci2102-110. Epub 2015 Apr 12.
Results Reference
background
PubMed Identifier
31568761
Citation
McIntosh K, Charbonneau R, Bensaada Y, Bhatiya U, Ho C. The Safety and Feasibility of Exoskeletal-Assisted Walking in Acute Rehabilitation After Spinal Cord Injury. Arch Phys Med Rehabil. 2020 Jan;101(1):113-120. doi: 10.1016/j.apmr.2019.09.005. Epub 2019 Sep 27.
Results Reference
background

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ExoAtlet II For SCI Patients

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