Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation

Technology
Standing/walking/mobility
Online since 15 March 2025, updated 85 days ago

About this trial

This trial is enrolling 20 participants with chronic spinal cord injury who have an implanted spinal cord stimulation (SCS) unit to test the effect of a robotic trainer, the Tethered Pelvic Assist Device (TPAD), in combination with SCS on balance. TPAD is a lightweight, cable-driven robotic stand trainer that assists movement with corrective forces and applies controlled perturbations to the trunk and pelvis during standing. SCS is a technique for stimulating the spinal cord with an implanted electrode placed next to the spinal cord to modify spinal cord function. If included, participants will undergo assessments with and without SCS. Additionally, they will either receive TPAD training over 4 months, or only undergo assessments over 3 weeks. Final testing of balance and muscle function will be performed after 4 months.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    have an implanted spinal cord epidural stimulation unit that is eligible for software upgrade as part of a previous study.
    be willing to discontinue anti-spasticity medications

    What’s involved

    Type

    Technology

    Details

    - Participants will undergo assessments with and without spinal cord stimulation (SCS). - SCS is a technique for stimulating the spinal cord with an implanted electrode placed next to the spinal cord to modify spinal cord function. - Additionally, they will either receive TPAD training over 4 months, or only undergo assessments over 3 weeks. - The TPAD is a lightweight, cable-driven robotic stand trainer that assists movement with corrective forces and applies controlled perturbations to the trunk and pelvis during standing. - Final testing of balance and muscle function will be performed after 4 months.

    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
    • 1 Nov 2024
    • Organisation
    • Kessler Foundation
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Nov 2024
    • Organisation
    • Kessler Foundation

    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