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

Ekso Bionics4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

EksoDEVICE

powered lower extremity exoskeleton

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ekso Bionics

Richmond, California, United States

Outcomes

Primary Outcomes

Number of Study Participants With Adverse Events

evaluate the safety of a subject walking with a lay spotter in a non-clinical environment

Time frame: through study completion for a maximum possible duration of 42 months

Secondary Outcomes

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.

Time frame: 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

Time frame: 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?

Time frame: through study completion for a maximum possible duration of 42 months

Data from ClinicalTrials.gov

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