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

NCT ID: NCT02566850

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-07-25

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ekso Users

SCI subjects using Ekso

Group Type: EXPERIMENTAL

Ekso

Intervention Type: DEVICE

powered lower extremity exoskeleton

Interventions

Ekso

powered lower extremity exoskeleton

Intervention Type: DEVICE

Other Intervention Names

Ekso GT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ekso Bionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ekso Bionics

Richmond, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

13098

Identifier Type: -

Identifier Source: org_study_id