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

Rehabilitation
General health
Online since 2 November 2021, updated 889 days ago

About this trial

This study is recruiting individuals with spinal cord injuries to test the Ekso Bionics powered exoskeleton device in a home setting. The robotic device powers lower extremities, enabling the movement of paralyzed legs. The study hopes to determine the practical use of the device in the home environment. The study requires a spotter (e.g. caregiver) to be trained and be present at all times the device is used. The study will also evaluate the effectiveness of a non-medically licensed spotter to assist the user. Participants will receive the exoskeleton and the training needed for its use at home. The study time will be 12-36 months.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    1 month - 65 years
  • Injury type
  • Non-traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    have a body height between 152 and 193cm (5’-6’33 feet)
    have a body weight of less than 100kg (<200 lbs)
    have a prior experience or be willing to train on 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. 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

    What’s involved

    Type

    Rehabilitation

    Details

    Usage of the Ekso Bionic exoskeleton in the home setting for 12-36 months. Supervision of the usage by a trained spotter (caregiver). Outcome assessments throughout the 12-36 months.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Bladder health

    Bone health

    Bowel health

    Mental health

    Pain

    Skin health

    Spasticity

    Standing/walking/mobility

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Jan 2014
    • Organisation
    • Ekso Bionics
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Jan 2014
    • Organisation
    • Ekso Bionics

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more