FES-assisted Gait Intervention in People With Spinal Cord Injury - Pilot Study

Technology
General health
Online since 30 November 2023, updated 82 days ago

About this trial

This pilot trial is enrolling, by invitation, 5 individuals with chronic, incomplete spinal cord injury to assess the feasibility and safety of walking training in combination with functional electrical stimulation (FES). FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. The trial will also assess the effects of FES-assisted walking training on walking function. If included, participants will walk with assistance from FES (and possible body weight support) on a treadmill for 30 minutes each time, twice per week over 10 weeks. Final walking testing will be performed after 11 weeks and after 21 weeks for safety.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    NOT have cardiac arrhythmias or cardiac disease
    NOT have a neurostimulator or pacemaker
    be able to walk on a treadmill for 30 minutes (with support)

    What’s involved

    Type

    Technology

    Details

    - Participants will walk with functional electrical stimulation (FES) on a treadmill for 30 minutes each time, twice per week over 10 weeks. - FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. - Final walking testing will be performed after 11 weeks and after 21 weeks for safety.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Standing/walking/mobility

    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
    • By invitation
    • Trial start date
    • 10 May 2023
    • Organisation
    • Stichting Reade
    • Trial recruitment status
    • By invitation
    • Trial start date
    • 10 May 2023
    • Organisation
    • Stichting Reade

    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