Spinal Cord Injuries Clinical Trial
— EXOATLET2SCIOfficial title:
ExoAtlet II Lower Extremity Exoskeleton Safety and Efficacy Use With Spinal Cord Injured Individuals
Verified date | July 2023 |
Source | ExoAtlet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Moscow Regional Research Clinical Institute. M.F. Vladimirsky | Moscow |
Lead Sponsor | Collaborator |
---|---|
ExoAtlet |
Russian Federation,
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
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 |
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