Clinical trial NCT04215081: ExoAtlet II For SCI Patients
Official title: ExoAtlet II Lower Extremity Exoskeleton Safety and Efficacy Use With Spinal Cord Injured Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Paraplegia
Lead sponsor: COSMO ROBOTICS CO., Ltd
Sponsor class: INDUSTRY
First posted: 2020-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SCI Level T4-L5 or, C7-T3 with ASIA D
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events
timeFrame: 0-8 weeks
measure: Skin integrity
timeFrame: 0-8 weeks
Secondary outcomes:
measure: 10 Meter Walk Test
timeFrame: 1 Day
measure: 6 Minute Walk Test
timeFrame: 1 Day
measure: Transfer in and out
timeFrame: 2 Days
measure: Perform Sit to Stand to Sit
timeFrame: 2 Days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institute. M.F. Vladimirsky
Study officials:
affiliation: Moscow Regional Research and Clinical Institute (MONIKI)
name: Sergey Kotov, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.