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

Ekso Bionics1 site in 1 country4 target enrollmentJanuary 2014

ConditionsSpinal Cord Injuries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injuries
Sponsor: Ekso Bionics
Enrollment: 4
Locations: 1
Primary Endpoint: Number of Study Participants With Adverse Events
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

July 25, 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ekso Bionics

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of Study Participants With Adverse Events

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

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

Secondary Outcomes

Borg Perceived Rate of Exertion(through study completion for a maximum possible duration of 42 months)
Spasticity as Tested by the Modified Ashworth Scale(through study completion for a maximum possible duration of 42 months)
International Spinal Cord Injury Data Sets Quality of Life Basic Data Set(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(through study completion for a maximum possible duration of 42 months)
International Spinal Cord Injury Data Sets(through study completion for a maximum possible duration of 42 months)
Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam)(through study completion for a maximum possible duration of 42 months)
Length of Participation in Study(through study completion for a maximum possible duration of 42 months)
International Spinal Cord Injury Data Sets Bowel Function Basic Data Set(through study completion for a maximum possible duration of 42 months)
Spinal Cord Independence Measure (SCIM) II(through study completion for a maximum possible duration of 42 months)
Secondary Health Conditions(Through study completion for a maximum possible duration of 42 months)