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

NCT02566850 | Terminated Results

• 1 other identifier: 13098
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Number of Study Participants With Adverse Events

  evaluate the safety of a subject walking with a lay spotter in a non-clinical environment

  through study completion for a maximum possible duration of 42 months

Secondary Outcomes (10)

• International Spinal Cord Injury Data Sets Quality of Life Basic Data Set

  through study completion for a maximum possible duration of 42 months

• International Spinal Cord Injury Data Sets Bowel Function Basic Data Set

  through study completion for a maximum possible duration of 42 months

• International Spinal Cord Injury Data Sets Bladder Function Basic Data Set - Number of Participants Who Reported Changes in Bladder Function

  through study completion for a maximum possible duration of 42 months

• Spasticity as Tested by the Modified Ashworth Scale

  through study completion for a maximum possible duration of 42 months

• International Spinal Cord Injury Data Sets

  through study completion for a maximum possible duration of 42 months

Study Arms (1)

Ekso Users

EXPERIMENTAL

SCI subjects using Ekso

Device: Ekso

Interventions

Ekso DEVICE

powered lower extremity exoskeleton

Also known as: Ekso GT

Ekso Users

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ekso Bionics: lead

Study Sites (1)

Ekso Bionics

Richmond, California, 94804, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Katherine Strausser PhD
• Organization: Ekso Bionics

kstrausser@eksobionics.com

(510) 529-2529

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 2, 2015
• Study Start: January 1, 2014
• Primary Completion: July 25, 2017
• Study Completion: July 25, 2017
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Locations

US (1)