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Spinal Cord InjuriesEXOATLET2SCINCT04215081

ExoAtlet II For SCI Patients

A study testing Gait training using ExoAtlet exoskeleton in people with Spinal Cord Injuries and Paraplegia, run by COSMO ROBOTICS CO., Ltd at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Spinal Cord Injuries, Paraplegia
What is being tested?
Gait training using ExoAtlet exoskeleton
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteRussia
Study dates
18 Nov 2019to 4 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Moscow, 129110

Other trials in Russia

About this study

Official title: 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.

Read the 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.

Being tested
Gait training using ExoAtlet exoskeleton
Medical subject headings
Spinal Cord Injuries, Paraplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gait training using ExoAtlet exoskeletonDevice

    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).

Study groups in NCT04215081
Study groupRoleWhat they receive
ExoAtlet II Safety and EfficacyExperimental20 participants with paraplegia from SCI will participate in gait training using ExoAtlet II powered exoskeleton.
Receives: Device: Gait training using ExoAtlet exoskeleton

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events

    Document and track any adverse events, both minor and major, during exoskeleton sessions.

    Measured: 0-8 weeks

  2. 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.

    Measured: 0-8 weeks

Secondary outcomes (4)

  1. 10 Meter Walk Test

    Assesses walking speed, in the exoskeleton, in meters per second over a distance of 10 meters

    Measured: 1 Day

  2. 6 Minute Walk Test

    Record the distance covered during a 6 minute walk test utilizing the exoskeleton, to evaluate users endurance

    Measured: 1 Day

  3. Transfer in and out

    Percentage of patients able to successfully transfer in and out of the exoskeleton with or without assistance

    Measured: 2 Days

  4. Perform Sit to Stand to Sit

    Percentage of patients that successfully completed both sit to stand and stand to sit in the exoskeleton

    Measured: 2 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2020
  2. Study start18 Nov 2019
  3. Primary completion4 Jan 2020
  4. Study completion4 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
SCI Level T4-L5 or, C7-T3 with ASIA D
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04215081
Sponsor's protocol ID
EA22019SCI
Acronym
EXOATLET2SCI
Status last verified
Jul 2023
First submitted
20 Dec 2019
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28865396

  • 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.

    PubMed 27042146

  • 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.

    PubMed 29434463

  • 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.

    PubMed 26364278

  • 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.

    PubMed 26364280

  • 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.

    PubMed 31568761

Questions about this trial

What is this clinical trial studying?

A study testing Gait training using ExoAtlet exoskeleton in people with Spinal Cord Injuries and Paraplegia, run by COSMO ROBOTICS CO., Ltd at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events (time frame: 0-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04215081, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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