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

Ekso Bionics

Status

Terminated

Conditions

Spinal Cord Injuries

Treatments

Device: Ekso

Study type

Interventional

Funder types

Industry

Identifiers

NCT02566850

13098

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.