Epidural Stimulation and Resistance Training After SCI

Technology
Standing/walking/mobility
Online since 9 September 2022, updated 586 days ago

About this trial

This is a trial enrolling individuals with spinal cord injuries to test the effect of resistance training combined with spinal cord stimulation on walking function. Spinal cord stimulation is a technique for stimulating the spinal cord to modify spinal cord function. In this trial, electrodes are surgically implanted next to the spinal cord. The training program includes walking exercises in a powered wearable robotic device (exoskeleton). The study targets the additional effects of lower limb resistance training on exoskeleton-assisted walking with spinal cord stimulation. If included, individuals will randomly be assigned to one of two study groups: a) either performing the study program of exoskeleton-assisted walking with spinal cord stimulation added after 6 months; or b) performing the study program of exoskeleton-assisted walking with spinal cord stimulation along with additional resistance training of the lower extremities. Final testing will be performed after 12 months.

Included participants

Gender
All
Age
18 - 60 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    All
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T10
    Additionally, participants must
    NOT have implanted pacemakers and/or implanted defibrillator devices
    NOT have untreatable severe spasticity

    What’s involved

    Type

    Technology

    Details

    - ES (Epidural Stimulation)= electrodes are surgically implanted next to the spinal cord - EAW=Exoskeleton-assisted walking - RT= Resistance training of the lower extremities - Outcome measures throughout the study duration -EAW+ES+RT (experimental group): EAW+ES (3x/week) for 6 months followed by another 6 months of EAW+ES (3x/wk) and progressive RT 2x/week. EAW+delayed-ES+no-RT (control group): EAW 3x/week (without RT) for 6 months followed by another 6 months of EAW+ES and passive movement/stretching 2x/week.

    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

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 3 Feb 2021
    • Organisation
    • United States Department of Defense
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 3 Feb 2021
    • Organisation
    • United States Department of Defense

    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