Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT02566850
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02566850
Study Brief:
Protocol Section:
NCT02566850