Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT

Technology
Standing/walking/mobility
Online since 13 December 2022, updated 439 days ago

About this trial

This trial is enrolling individuals with chronic incomplete spinal cord injuries to test the effect of combining functional electrical stimulation (FES) and overground training using an externally worn powered robotic device (EksoNR powered exoskeleton ) on walking. FES is a technique that applies electrical stimulation through the skin to nerves that cause contraction of weakened muscles. If included, participants will train for 8 weeks, 3 times per week for 30 minutes (24 sessions in total) with either: 1) EksoNR with FES; or 2) EksoNR without FES. Researchers want to see if the addition of FES to powered exoskeleton walking improves outcomes more than exoskeleton walking alone. Testing will include walk speed, endurance, balance, muscle strength, cardio-respiratory function and quality of life.

Included participants

Gender
All
Age
≥ 18 years
Injury level
Level not specified
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    Level not specified
    Additionally, participants must
    have the capacity to stand up and perform a 10MWT with or without medical aids
    be partially wheelchair dependent
    NOT suffer severe spasticity

    What’s involved

    Type

    Technology

    Details

    - Participants will train for 8 weeks, 3 times per week (i.e. 24 sessions in total) for 30 minutes with either 1) EksoNR with FES or 2) EksoNR without FES. - Final testing will be performed after 3 months after training is completed.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    Mental 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
    • 18 Mar 2022
    • Organisation
    • Swiss Paraplegic Research, Nottwil
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 18 Mar 2022
    • Organisation
    • Swiss Paraplegic Research, Nottwil

    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