Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Home and Community Setting (SC140121 Study 3)

Rehabilitation
Standing/walking/mobility
Online since 4 November 2021, updated 895 days ago

About this trial

This trial is enrolling individuals with chronic spinal cord injuries to investigate the benefits of an externally worn powered robotic device (exoskeleton) to assist movement. This study will use the Parker Indego exoskeleton. Researchers want to see if exoskeleton use offers improved mobility, neurological recovery, and health benefits. If selected for the trial, participants will use the exoskeleton in the home and community environment over an 8-week period under the supervision of a trained companion. The study will measure gait speed, functional independence (the need for assistance) and several health factors (e.g. improvements in muscle strength, bone health, pain, spasticity, bowel and bladder function). User compliance, the extent the exoskeleton is used beyond the minimum required for the study, will also be measured.

Included participants

Gender
All
Age
≥ 18 years
Injury level
T3 - L5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T3-L5
    Additionally, participants must
    have previously participated in Study 1 of Study 2 of this project
    be able to walk short distances
    have upper extremity strength and coordination to balance using appropriate stability aids, such as a rolling walker or forearm crutches

    What’s involved

    Type

    Rehabilitation

    Details

    Take home the exoskeleton for an 8-week period Use the exoskeleton for walking with supervision of a specially trained companion (in accordance with the user assessment and training certification program) Complete follow-up measures at 18 weeks. Follow-up measures assess walking ability with and without the exoskeleton, difficulty walking, how much help is needed to walk, spasticity, balance, muscle strength, and sensation.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bone health

    General health

    Spasticity

    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 May 2020
    • Organisation
    • Vanderbilt University
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 May 2020
    • Organisation
    • Vanderbilt University

    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