Randomized Controlled Trial on Robotic Exoskeleton in Spinal Cord Injury: Clinical Outcomes and Cortical Plasticity

Technology
Standing/walking/mobility
Online since 3 November 2021, updated 946 days ago

About this trial

This trial is enrolling individuals with chronic incomplete spinal cord injuries to test the effect of gait (walking) training with a robotic exoskeleton. Walking training with the exoskeleton (EKSO-GT) will be accompanied by standard locomotor rehabilitation (treadmill stepping). In addition to potential improvements in walking, the trial will use techniques including MRI imaging and EEG signaling during sleep to measure changes in the brain as a result of the training. Researchers want to know if exoskeleton training causes the brain or spinal cord to initiate an adaptive or remodeling response. There are two groups in the study. If selected for the trial, participants will either receive 1) standard locomotor training 2.5 hours per day, 5 days per week over 8 weeks; or 2) the same amount of locomotor training plus 30-40 minute sessions of exoskeleton training, 3 times per week during the first 4 weeks.

Included participants

Gender
All
Age
18 - 65 years
Injury level
T1 - L1
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    1 year - 5 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    T1-L1
    Additionally, participants must
    have some functional gait ability (also with braces or orthoses).
    have a body height between 157 and 188 cm (5’18-6’2 feet).
    have a body weight below 100 kg (220 lbs).

    What’s involved

    Type

    Technology

    Details

    8-week study period: Standard neurorehabilitation walking training, 5 times per week, twice a day, for a total of about 2.5 hours per day. If assigned to the experimental arms using the robotic exoskeleton: Additional training sessions during the first 4 consecutive weeks of the study period. Each rehabilitation session with EKSO-GT will last (operating time) 30-40 minutes. Such training will be carried out for 3 sessions per week.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    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
    • Unknown
    • Trial start date
    • 10 Dec 2020
    • Organisation
    • Azienda Usl di Bologna
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 10 Dec 2020
    • Organisation
    • Azienda Usl di Bologna

    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