NCT02566850

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Ekso Bionics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Ekso	powered lower extremity exoskeleton

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-07-25
• Completion: 2017-07-25
• First posted: 2015-10-02
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

1 site across 1 country: United States