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

NCT01701388 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-04

No results posted yet for this study

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

Interventions

DEVICE

Ekso exoskeleton

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Arun Jayaraman, PhD · RIC/Northwestern

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701388 on ClinicalTrials.gov