Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment

Study Overview
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Brief Summary
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The purpose of the study is to study the safety and health effects of using the Ekso Bionics powered exoskeleton device in a home setting over an extended period, ranging from 12-42 months.

Detailed Description
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This is a 36 month exploratory Investigational Study compliant with the NSF Human Subjects regulations (45 CFR 690) trialing a new device for the SCI populations to aid in ambulatory function in a home setting. Ekso Bionics will enable up to twelve (12) subjects with SCI to use an Ekso device in their home for a 12-month period. Qualified subjects will help Ekso Bionics determine the practical use of the device in the home environment and will enable Ekso Bionics to gather data to develop a device for use in a home environment. The study will require a trained spotter to be present at all times that the device is being used. The study will also evaluate the effectiveness of a non-medically licensed spotter to assist the subject.

Official Title
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Investigational Study of the Ekso Bionics Powered Exoskeleton for High-Dosage Use by Individuals With Spinal Cord Injury in a Non-Clinical Environment

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Ekso


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be an experienced user of the Ekso device with a minimum of 20 hours and no more than 50 hours of device use and require no greater than minimal assist (support of up to 25% body weight) for safe and consistent walking. no more than 2 episodes of balance loss per 1 hour training session that require no more than moderate assistance (support of 26% to 50% of body weight) participants with more than 50 hours of device experience must agree to a 1 month period of non-use prior to acquisition of baseline measures be between 18-65 years of age. be able to physically fit into the exoskeleton device. be able to tolerate upright standing for up to 60 minutes. have sufficient joint range of motion to fit safely within Ekso: Hip flexion contracture ≤ 15o; knee flexion contracture ≤ 10o; ankle dorsiflexion to neutral with no more than 10o of knee flexion. have sufficient upper body strength to balance themselves with two arms be fluent in English Exclusion Criteria: Height below 60 inches or above 76 inches or with physical characteristics incompatible with device and testing procedure. Weight above 220 lbs. Lower extremity joint contractures that exceed device capacity for safe use. Any medical issue that precludes full weight bearing and ambulation (e.g. osteoporosis that prevents safe standing, orthopedic injuries, pain, severe spasticity) Skin integrity issues that would prevent wearing the device. Cognitive and/or communicative disability inappropriate for testing as determined by Ekso Bionics clinician. Subjects must be able to follow directions well and demonstrate learning capability. Pregnancy (Self-reported) Colostomy Medical or environmental conditions arising after the start of the study that are deemed unsafe per Ekso Bionics discretion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ekso Users<br>SCI subjects using Ekso | Device: Ekso<br>* powered lower extremity exoskeleton<br>* Other names: Ekso GT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Study Participants With Adverse Events | evaluate the safety of a subject walking with a lay spotter in a non-clinical environment | through study completion for a maximum possible duration of 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Spinal Cord Injury Data Sets Quality of Life Basic Data Set | Consists of 3 variables: ratings of satisfaction with general quality of life, satisfaction with physical health, and satisfaction with psychological health. All variables are rated on a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied) with a total of 30 points. | through study completion for a maximum possible duration of 42 months | 
| International Spinal Cord Injury Data Sets Bowel Function Basic Data Set | evaluate the impact on subject's bowel health, subjective questionnaire. Examined time required for defecation in minutes, with shorter time being more favorable | through study completion for a maximum possible duration of 42 months | 
| International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function | evaluate the impact on subject's bladder health, subjective feedback and written answers collected, no numerical scoring is part of this exam. This data set asks the following questions: Urinary tract impairment unrelated to spinal cord lesion? Awareness of the need to empty the bladder? How does bladder emptying occur? Average number of voluntary bladder emptyings per 24 hours during the last week? Any involuntary urine leakage (urinary incontinence) within the last four weeks? Collecting appliances for urinary incontinence? Any drugs with possible influence on the urinary tract within the last four weeks? Surgical procedures on the urinary tract? Any change in lower urinary tract symptoms within the last year? | through study completion for a maximum possible duration of 42 months | 
| Spasticity as Tested by the Modified Ashworth Scale | evaluate the impact on subject's spasticity, assessed Elbow Flexors / Extensors, Wrist Flexors / Extensors, Hip Flexors / Extensors, Hip Abductors, Knee Flexors / Extensors, Ankle Plantar Flexors, Ankle Invertors and totaled spasticity for each group (0-5 for right and left) to total between 0 and 70. Higher scores for each muscle group indicate more rigid spasticity, and higher total score indicates more muscle groups involved. | through study completion for a maximum possible duration of 42 months | 
| International Spinal Cord Injury Data Sets | evaluate the impact on subject's pain. Totaled the following questions with scales from 0-10 for a total score ranging from 0-50. For each question, 0 = No interference, 10 = Extreme interference How much has pain changed your ability to take part in recreational and other social activities? How much has pain changed the amount of satisfaction or enjoyment you get from family related activities? In general, how much has pain interfered with your day to day activities in the last week? In general, how much has pain interfered with your overall mood in the past week? In general, how much has pain interfered with your ability to get a good night's sleep? | through study completion for a maximum possible duration of 42 months | 
| Spinal Cord Independence Measure (SCIM) II | evaluate the impact on subject's functional abilities in 3 domains (self care, respiration and sphicter management, mobility) on a scale from 0-100. Each of the 17 total questions have multiple options that are scored in different values. Some questions range from 0-1 points, while others range from 0-2,0-3, 0-5, 0-8, 0-6,0-10, or 0-15. Higher values for each question, and overall, indicate more independence with the task, while lower scores indicates requiring of more assistance. | through study completion for a maximum possible duration of 42 months | 
| Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam) | evaluate the impact on subject's muscle strength. Total upper and lower extremity motor scores (0-5 for right and left) for each of the following muscle groups for a total of 120 points. For each muscle group, 0 is defined as no palpable contraction, while 5 is full strength. Shoulder Flexion Shoulder Extension Elbow Flexion Elbow Extension Wrist Extension Gross Grip Strength Hip Flexion Hip Extension Hip Abduction Knee Extension Ankle Dorsiflexion Ankle Plantar Flexion | through study completion for a maximum possible duration of 42 months | 
| Borg Perceived Rate of Exertion | evaluate the impact on subject's effort while walking. Measure taken for each session on scale from 6-20. Average was taken from each participant over their total number of sessions. Higher scores on the Borg indicates the participants feels like they are working harder. | through study completion for a maximum possible duration of 42 months | 
| Length of Participation in Study | Number of months that a participant utilized the Ekso in their home with a lay spotter | through study completion for a maximum possible duration of 42 months | 
| Secondary Health Conditions | Frequency of secondary health complications as reported by participants | Through study completion for a maximum possible duration of 42 months |