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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ExoAtlet II Safety and Efficacy | Experimental | 20 participants with paraplegia from SCI will participate in gait training using ExoAtlet II powered exoskeleton. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 10 Meter Walk Test | Assesses walking speed, in the exoskeleton, in meters per second over a distance of 10 meters | 1 Day |
| 6 Minute Walk Test | Record the distance covered during a 6 minute walk test utilizing the exoskeleton, to evaluate users endurance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey Kotov, MD | Moscow Regional Research and Clinical Institute (MONIKI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Regional Research Clinical Institute. M.F. Vladimirsky | Moscow | 129110 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28865396 | Background | 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. | |
| 27042146 |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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SCI Level T4-L5 or, C7-T3 with ASIA D
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| 1 Day |
| Transfer in and out | Percentage of patients able to successfully transfer in and out of the exoskeleton with or without assistance | 2 Days |
| 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 |
| 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. |
| 29434463 | 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. |
| 26364278 | 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. |
| 26364280 | 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. |
| 31568761 | 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. |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |