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

Stopped early · Not applicable

Conditions studied: Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT02566850

Run by

Ekso Bionics

People needed

4

Starts

2014-01-01

Expected to finish

2017-07-25

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Ekso Bionics — Richmond, California, United States

Full record on ClinicalTrials.gov

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