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

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ClinicalTrials.gov Identifier: NCT02566850
Recruitment Status : Enrolling by invitation
First Posted : October 2, 2015
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Ekso Bionics

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 a 12-36 month period.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Ekso Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : January 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ekso Users
SCI subjects using Ekso
Device: Ekso
powered lower extremity exoskeleton
Other Name: Ekso GT




Primary Outcome Measures :
  1. Number of study participants with adverse events [ Time Frame: 12-36 months ]
    evaluate the safety of a subject walking with a lay spotter in a non-clinical environment


Secondary Outcome Measures :
  1. International Spinal Cord Injury Data Sets Quality of Life Basic Data Set [ Time Frame: 12-36 months ]
    evaluate the impact on subject's perception of quality of life

  2. International Spinal Cord Injury Data Sets Bowel Function Basic Data Set [ Time Frame: 12-36 months ]
    evaluate the impact on subject's bowel health

  3. International Spinal Cord Injury Data Sets Bladder Function Basic Data Set [ Time Frame: 12-36 months ]
    evaluate the impact on subject's bladder health

  4. Spasticity as tested by the Modified Ashworth Scale [ Time Frame: 12-36 months ]
    evaluate the impact on subject's spasticity

  5. International Spinal Cord Injury Data Sets [ Time Frame: 12-36 months ]
    evaluate the impact on subject's pain

  6. Spinal Cord Independence Measure (SCIM) II [ Time Frame: 12-36 months ]
    evaluate the impact on subject's functional abilities

  7. Secondary health conditions [ Time Frame: 12-36 months ]
    evaluate the impact on subject's secondary health conditions such as pressure sores, UTIs, etc.

  8. Bone Density as measured by DEXA Scan [ Time Frame: 12-36 months ]
    evaluate the impact on subject's bone density as measured by DEXA Scan

  9. Strength via Upper and Lower Extremity Motor Scors (ISNCSCI Exam) [ Time Frame: 12-36 months ]
    evaluate the impact on subject's muscle strength

  10. Borg Perceived Rate of Exertion [ Time Frame: 12-36 months ]
    evaluate the impact on subject's effort while walking



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566850


Locations
United States, California
Ekso Bionics
Richmond, California, United States, 94804
Sponsors and Collaborators
Ekso Bionics

Responsible Party: Ekso Bionics
ClinicalTrials.gov Identifier: NCT02566850     History of Changes
Other Study ID Numbers: 13098
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries