Motor & Autonomic Concomitant Health Improvements With Neuromodulation & Exercise Training: An SCI RCT

Technology
Standing/walking/mobility
Online since 6 November 2021, updated 943 days ago

About this trial

This is a clinical trial recruiting individuals with spinal cord injuries to measure the effect of training in a robotic exoskeleton with and without electrical spinal cord stimulation on voluntary motor function. An exoskeleton is an externally worn powered robotic device to assist movement; this study uses a Lokomat model. Spinal cord stimulation is a technique for activating spinal cord nerve networks, in this case by way of skin-surface electrodes, applied at the lower back. If selected, participants will receive activity-based therapy three sessions/week for 12 weeks; this includes balance and gait training with complete assistance of the exoskeleton. All participants will use the exoskeleton, and will be assigned to one of two study groups: 1) performing the activity-based therapy with spinal cord stimulation; or performing the activity-based therapy with sham (inactive) spinal cord stimulation (participant will not know if the stimulation is on or not). Researchers will assess voluntary muscle contractions, balance, blood pressure, cardiovascular effects, bowel, bladder and sexual function, fatigue, and quality of life effects. Final testing will be performed after 14 weeks.

Included participants

Gender
All
Age
18 - 60 years
Injury level
C1 - T6
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    1 year - 60 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T6
    Additionally, participants must
    be between 1.58m and 1.88m (5.1 and 6.1 feet)
    be less than 136kg (300 pounds)
    be a resident of British Columbia, Canada with active provincial medical services plan

    What’s involved

    Type

    Technology

    Details

    Three 50-minute therapy sessions per week, for 12 weeks Therapy sessions include balance and gait training while wearing a robotic exoskeleton AND surface electrodes on the lower back Testing before and after the 12 weeks of therapy

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bladder health/function

    Bowel health

    General health

    Mental health and psychosocial factors

    Sexual health

    Spasticity

    Mechanism of action

    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
    • 22 Jul 2022
    • Organisation
    • University of British Columbia
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 22 Jul 2022
    • Organisation
    • University of British Columbia

    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