Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

Technology
Standing/walking/mobility
Online since 29 November 2023, updated 83 days ago

About this trial

This pilot trial is enrolling 15 individuals with spinal cord injuries, brain injuries, or acquired muscle weakness to test a new functional electrical stimulation (FES) device on leg muscle strength while cycling. FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. While using an FES cycle, stimulation is applied to leg muscles to help the user pedal. If included, participants will receive 16 30-minute sessions of either: 1) conventional physical therapy; 2) therapy with an existing FES cycling device; or 3) therapy with the new FES cycling device. Final testing will be performed after 8 weeks.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    NOT have amputations of lower limbs at any level

    What’s involved

    Type

    Technology

    Details

    - Participants will receive 16 sessions of 30 minutes. This will be either 1) conventional physical therapy, 2) therapy with an existing FES cycling device or 3) therapy with the new FES cycling device. - FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. - While using an FES cycle, stimulation is applied to the leg muscles to help the user pedal. - Final testing will be performed after 8 weeks.

    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 soon
    • Trial start date
    • 1 Jun 2023
    • Organisation
    • University of Sao Paulo General Hospital
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Jun 2023
    • Organisation
    • University of Sao Paulo General Hospital

    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