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

Running, not enrolling · Not applicable

Conditions studied: Spinal Cord Injuries or Similar Neurological Weakness

In brief

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.

Key facts

Study ID

NCT01701388

Run by

Shirley Ryan AbilityLab

People needed

40

Starts

2012-05-01

Expected to finish

2025-12-31

Last updated by the study team

2024-12-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• have a different neurological weakness than SCI but fit the other inclusion criteria above

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.

Where it is running

• Rehabilitation Institute of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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