ExoAtlet II For SCI Patients

NCT04215081 | Completed

• 1 other identifier: EA22019SCI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Paraplegia

Outcome Measures

Primary Outcomes (2)

• Number of adverse events

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

  0-8 weeks

• 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.

  0-8 weeks

Secondary Outcomes (4)

• 10 Meter Walk Test

  1 Day

• 6 Minute Walk Test

  1 Day

• Transfer in and out

  2 Days

• Perform Sit to Stand to Sit

  2 Days

Study Arms (1)

ExoAtlet II Safety and Efficacy

EXPERIMENTAL

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

Device: Gait training using ExoAtlet exoskeleton

Interventions

Gait training using ExoAtlet exoskeleton DEVICE

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).

ExoAtlet II Safety and Efficacy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• COSMO ROBOTICS CO., Ltd: lead

Study Sites (1)

Moscow Regional Research Clinical Institute. M.F. Vladimirsky

Moscow, 129110, Russia

Location

Related Publications (6)

• 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.

  PMID: 28865396 BACKGROUND

• 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.

  PMID: 27042146 BACKGROUND

• 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.

  PMID: 29434463 BACKGROUND

• 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.

  PMID: 26364278 BACKGROUND

• 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.

  PMID: 26364280 BACKGROUND

• 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.

  PMID: 31568761 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergey Kotov, MD

  Moscow Regional Research and Clinical Institute (MONIKI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SCI Level T4-L5 or, C7-T3 with ASIA D

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 2, 2020
• Study Start: November 18, 2019
• Primary Completion: January 4, 2020
• Study Completion: January 4, 2020
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)