Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting

Technology
Standing/walking/mobility
Online since 11 November 2021, updated 27 days ago

About this trial

This is a clinical trial to test the use of an exoskeleton on walking function after spinal cord injury. An exoskeleton is an externally worn, powered, robotic device to assist movement. This study uses a commercial device (ABLE Human Motion) that is more compact and lightweight than other such devices (per the research team). The study will assess the usability of the device, including assistance needed to put the device on and take it off and performance of activities required for the study. If included, the participant will undergo 12 training sessions using the exoskeleton. Final testing will be performed after up to 8 weeks, measuring potential effects of the training on walking, general health status, user satisfaction, and quality of life.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 70 years
  • Injury type
  • Traumatic

    Non-traumatic

    Ischemia

    Healthy volunteers
    Yes
    C1-S5
    Additionally, participants must
    have sufficient arm strength to support body weight on a walking frame
    be receiving treatment at one of the investigational sites

    What’s involved

    Type

    Technology

    Details

    wear the robotic exoskeleton "ABLE" for the training sessions. undergo a training program taking place 3 times a week for 4-6 weeks for a total of 12 sessions. undergo tests for walking and activities of daily living

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    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

    • Recruitment
    • Unknown
    • Trial start date
    • 3 Nov 2020
    • Organisation
    • ABLE Human Motion S.L.
    • Recruitment
    • Unknown
    • Trial start date
    • 3 Nov 2020
    • Organisation
    • ABLE Human Motion S.L.

    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