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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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).
Moscow Regional Research Clinical Institute. M.F. Vladimirsky
Moscow, Russia
Number of adverse events
Document and track any adverse events, both minor and major, during exoskeleton sessions.
Time frame: 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.
Time frame: 0-8 weeks
10 Meter Walk Test
Assesses walking speed, in the exoskeleton, in meters per second over a distance of 10 meters
Time frame: 1 Day
6 Minute Walk Test
Record the distance covered during a 6 minute walk test utilizing the exoskeleton, to evaluate users endurance
Time frame: 1 Day
Transfer in and out
Percentage of patients able to successfully transfer in and out of the exoskeleton with or without assistance
Time frame: 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
Time frame: 2 Days
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