Clinical trial NCT02566850: Investigational Study of the Ekso for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment
Official title: Investigational Study of the Ekso Bionics Powered Exoskeleton for High-Dosage Use by Individuals With Spinal Cord Injury in a Non-Clinical Environment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Ekso Bionics
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of Study Participants With Adverse Events
timeFrame: through study completion for a maximum possible duration of 42 months
Secondary outcomes:
measure: International Spinal Cord Injury Data Sets Quality of Life Basic Data Set
timeFrame: through study completion for a maximum possible duration of 42 months
measure: International Spinal Cord Injury Data Sets Bowel Function Basic Data Set
timeFrame: through study completion for a maximum possible duration of 42 months
measure: International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function
timeFrame: through study completion for a maximum possible duration of 42 months
measure: Spasticity as Tested by the Modified Ashworth Scale
timeFrame: through study completion for a maximum possible duration of 42 months
measure: International Spinal Cord Injury Data Sets
timeFrame: through study completion for a maximum possible duration of 42 months
measure: Spinal Cord Independence Measure (SCIM) II
timeFrame: through study completion for a maximum possible duration of 42 months
measure: Strength Via Upper and Lower Extremity Motor Scors (ISNCSCI Exam)
timeFrame: through study completion for a maximum possible duration of 42 months
measure: Borg Perceived Rate of Exertion
timeFrame: through study completion for a maximum possible duration of 42 months
measure: Length of Participation in Study
timeFrame: through study completion for a maximum possible duration of 42 months
measure: Secondary Health Conditions
timeFrame: Through study completion for a maximum possible duration of 42 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Ekso Bionics
state: California
Study officials:
References: