EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With Spinal Cord Injury (SCI)

NCT01701388 | Active Not Recruiting DMC

• 1 other identifier: NU59727
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to test the safety and efficacy of the Esko device in SCI population and in populations with similar neurological weakness to the SCI population. The device can currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as follows:

• Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance while wearing the device as noted by subject's ability to safely achieve standing balance for 30 sec without loss of balance.
• Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to safely ambulate 10 meters to be assessed using the 10 meter walk test.
• Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift in both static and dynamic activities as determined by a trained physical therapist.
• Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with training of the device as noted by subjective questionnaires that will be assessed following each training session.

Conditions

Spinal Cord Injuries or Similar Neurological Weakness

Keywords

Ekso; Exoskeleton; Spinal Cord Injury; Motor Complete Incomplete

Outcome Measures

Primary Outcomes (2)

• Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE), and oxygen uptake

  The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The instructions are "Walk continuously if possible, but do not be concerned if you need to slow down or stop to rest." At the end of 6 minutes the participant is asked to rate their exertion level on a Borg Scale of 6 - 20 points. The maximal oxygen consumption (VO2 MAX) data is collected during the test every 10 seconds

  Testing Day 1 - 3 and follow up testing Week 6 and Week 12.

• Change in 10 meter walk test from baseline in gait speed

  Measure the time in second for and individual to walk 10 meters. The test is performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: " Please walk this distance as fast as you safely can when I say go."

  Testing Day 1 - 3 and follow up testing Week 6 and Week 12

Secondary Outcomes (3)

• Ratio of number of steps/walking time

  Testing Day 1 - 3 and follow up testing Week 6 and Week 12.

• 2 Minute Walk Test

  Testing Day 1 and follow up testing Week 6 and Week 12

• Walk time to stand time ratio on a particular assistive device

  Testing Day 1 and follow up testing Week 6 and Week 12

Other Outcomes (1)

• Psychosocial Impact of Assistive Device Scale (PIADS)

  Day 1- 3 after the first trial of the Ekso, follow up testing on Week 6 and Week 12

Study Arms (1)

Ekso Safety and Efficacy

EXPERIMENTAL

Observational study on the first time use of a robotic exoskeleton.

Device: Ekso exoskeleton

Interventions

Ekso exoskeleton DEVICE

The participants will receive 1 - 40 training sessions. The sessions will be 1 hour of device use including balance training, gait training and sit to and from stand training with rolling walker and/ or forearm crutches.

Also known as: Ekso by Eksobionics

Ekso Safety and Efficacy

Eligibility Criteria

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

You may qualify if:

• Participants must:
• have a spinal cord injury SCI between C7-S1.
• be between 18-65 years of age.
• be able to physically fit into the exoskeletal device.
• be able to tolerate upright standing for a minimum of 30 minutes.
• have joint range of motion (ROM) within normal functional limits for ambulation.
• have sufficient upper body strength to balance themselves using the walker while wearing the exoskeleton.

You may not qualify if:

• Height below 62 inches or above 74 inches
• Weight above 220 lbs.
• Joint contractures of any extremity that limits normal ROM during ambulation with assistive devices.
• Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity)
• Skin issues that would prevent wearing the device.
• Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be able to follow directions well and demonstrate learning capability.
• Significant Osteoporosis: Osteoporosis will be graded based on the T score that indicates a person's bone mineral content and is graded as follows: (14)
• T +1: Normal bone density:
• T -1 to -2.5: Low bone density of osteopenia
• T -2.5 to -3.0: osteoporosis
• T \<-3.0: Severe osteoporosis
• If the patient has severe osteoporosis and a T score of \<-3, participation in the study will be considered based upon their physicians recommendation and overall evaluation of the patient.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• United States Department of Defense: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, 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

Study Officials

• Arun Jayaraman, PhD

  RIC/Northwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: October 5, 2012
• Study Start: May 1, 2012
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

US (1)