ExoAtlet II For SCI Patients

Spinal Cord Injuries Clinical Trial

— EXOATLET2SCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215081
• Other study ID #: EA22019SCI
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: January 4, 2020

Study information

• Verified date: July 2023
• Source: ExoAtlet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 4, 2020
• Est. primary completion date: January 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Paraplegia
• Spinal Cord Injuries

Intervention

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).

Locations

Country	Name	City	State
Russian Federation	Moscow Regional Research Clinical Institute. M.F. Vladimirsky	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
ExoAtlet

Country where clinical trial is conducted

Russian Federation, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	Document and track any adverse events, both minor and major, during exoskeleton sessions.	0-8 weeks
Primary	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	10 Meter Walk Test	Assesses walking speed, in the exoskeleton, in meters per second over a distance of 10 meters	1 Day
Secondary	6 Minute Walk Test	Record the distance covered during a 6 minute walk test utilizing the exoskeleton, to evaluate users endurance	1 Day
Secondary	Transfer in and out	Percentage of patients able to successfully transfer in and out of the exoskeleton with or without assistance	2 Days
Secondary	Perform Sit to Stand to Sit	Percentage of patients that successfully completed both sit to stand and stand to sit in the exoskeleton	2 Days