ExoAtlet II For SCI Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Spinal Cord Injuries, Paraplegia

Intervention / Treatment
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* Device: Gait training using ExoAtlet exoskeleton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years of age or older in general good health Weight, no more than 220lbs (100kg) Skin must be healthy where it touches the ExoAtlet 2.0 Able to stand using a device such as a standing frame Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker Have good control of upper body 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 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 Hip width no greater than 18 (46 cm) measured when sitting. Femur length between 37 cm and 49 cm measured between mid patellar tendon and the floor. In general, good health and able to tolerate moderate levels of activity. 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: Spinal cord injury level higher than T4 or C7 ASIA D Severe muscle stiffness/tightness Significant spasticity (Modified Ashworth Scale score of 3 or above) Trunk or lower extremity pressure ulcer Open Wounds/tissue hypersensitivity Unstable spine, un-healed limbs, or fractures Severe sensitivity to touch Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints Joint instability, dislocation, moderate to severe hip dysplasia Significant scoliosis (>40 degrees) Hardware, implant, or any external device impeding with safe fitting or use of ExoAtlet 2.0 Femoral or tibial rotation deformity (>15 degrees) Significant flexion contractures limited to 35º at the hip and 20º at the knee Uncontrolled seizures, musculoskeletal injury, fracture or lower-limb surgery in past year. Known history of pulmonary disease limiting exercise tolerance or history of cardiac disease Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton. Severe concurrent medical diseases, illness, systemic or peripheral infection Dizziness or headache with standing History of autonomic dysreflexia Orthostatic Hypotension: Decrease in Systolic BP > 20, Diastolic BP > 10 upon standing from a seated position. Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: SCI Level T4-L5 or, C7-T3 with ASIA D
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ExoAtlet II Safety and Efficacy<br>20 participants with paraplegia from SCI will participate in gait training using ExoAtlet II powered exoskeleton. | Device: Gait training using ExoAtlet exoskeleton<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |