Early FES Cycling in Acute Spinal Cord Injury for Neuromuscular Preservation and Neurorecovery

Rehabilitation
Standing/walking/mobility
Online since 18 October 2022, updated 636 days ago

About this trial

This trial is enrolling individuals with acute spinal cord injuries (14 to 21 days since injury) to test the effect of functional electrical stimulation (FES) leg cycling on leg muscle atrophy, pain, spasticity, and neurological outcomes. FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. In this case FES is applied in order to determine if it prevents muscle wasting, pain, and spasticity and improves recovery if begun early following spinal cord injury. . If included, participants will be randomly assigned to one of three study groups: a) receive standard care only; b) receive the FES cycling program in the first three months of the study; or c) receive the FES cycling program in the second three months of the study. Final testing will be performed after 6 months.

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - L5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    14 days - 21 days
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-L5
    Additionally, participants must
    NOT be able to walk without assistive devices
    NOT have contraindications for Transcranial Magnetic Stimulation (TMS)
    NOT have autonomic dysreflexia

    What’s involved

    Type

    Rehabilitation

    Details

    Assigned to one of three study arms: 1. Standard of care 2. Electrical stimulation of weakened or paralyzed muscles of the legs in an FES cycling program for 6 months beginning 14-21 days post injury 3. Electrical stimulation of weakened or paralyzed muscles of the legs in an FES cycling program for 3 months beginning 3 months after enrollment - Outcome measures throughout the study, up to 6 months

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    General health

    Mental health and psychosocial factors

    Pain

    Sensory function

    Spasticity

    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
    • Ended
    • Trial start date
    • 21 Apr 2021
    • Organisation
    • University of Alberta
    • Trial recruitment status
    • Ended
    • Trial start date
    • 21 Apr 2021
    • Organisation
    • University of Alberta

    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