Powered Exoskeleton for Spinal Cord Injury (EKSO Trial)

Palo Alto (17 mi)

Overseen byArun Jayaraman, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Shirley Ryan AbilityLab

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-65 with spinal cord injury (SCI) levels C7-S1 or similar neurological weakness, who can fit into and tolerate the Ekso exoskeleton. They must stand for 30 minutes and have upper body strength to use a walker. Excluded are those with skin issues, cognitive impairments, extreme height/weight, joint contractures limiting movement, severe osteoporosis without physician approval.

Treatment Details

The EKSO Trial tests the safety and effectiveness of an Ekso powered exoskeleton in helping individuals with SCI walk again. It evaluates balance improvement while standing, ability to walk 10 meters safely, better weight shifting during movement as assessed by therapists, and user feedback on device training success.

1Treatment groups

Experimental Treatment

Group I: Ekso Safety and EfficacyExperimental Treatment1 Intervention

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