Patient-centered Assessment of the Effects of Powered Exoskeleton Use in People With Spinal Cord Injury

Rehabilitation
Mental health
Online since 8 September 2023, updated 165 days ago

About this trial

This trial is enrolling 18 individuals with chronic spinal cord injuries (above T5) to test the effect of using an exoskeleton (externally worn powered robotic device to assist movement) on quality of life. If included, participants will undergo either: 1) exoskeleton use at home for 24 months; or 2) an intense 1-week exoskeleton training session in a clinical setting, every three months. Every six months, all participants (both home and clinical settings) will attend a single-day session consisting of walking activities with the exoskeleton, compilation of questionnaires, and physical examinations made by a physiatrist. Final testing will be performed after 24 months.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - T4
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C1-T4

    What’s involved

    Type

    Rehabilitation

    Details

    Participants will undergo either - 1) exoskeleton use at home for 24 months - 2) an intense 1-week exoskeleton training session in a clinical setting, every three months. - Every six months, all individuals (both home and clinical setting) will attend a single-day session consisting of walking activities with the exoskeleton, compilation of questionnaires, sub-maximal effort test with arm-ergometer, and physical examinations made by a physiatrist.

    Potential benefits

    Main benefits

    Mental health

    Additional benefits

    Pain

    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
    • Recruiting soon
    • Trial start date
    • 1 Jan 2024
    • Organisation
    • Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Jan 2024
    • Organisation
    • Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

    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