Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)

Rehabilitation
Standing/walking/mobility
Online since 5 November 2021, updated 837 days ago

About this trial

This is a clinical trial recruiting individuals with incomplete spinal cord injuries to test the effect of a new balance training method on the frequency of falls. Incomplete SCI reduces a person’s ability to perform reactive steps to prevent falls, thus reactive balance training (RBT) is used to help with fall prevention. This training involves having individuals stand on a moveable plate while secured with a harness at waist level. Movement of the plate can provoke a loss of balance and help the individual learn to respond in a safe manner. This study will combine RBT with electrical stimulation of leg muscles, with the expectation that this may help the balance training. Functional electrical stimulation (FES) is a technique that applies stimulation through electrodes applied to the skin to activate nerves and cause contraction of weakened or paralyzed muscles. If included, participants will be assigned to one of two study groups: 1) receiving the RBT alone; or 2) receiving RBT training combined with FES. Each will complete 18 training sessions over 6 weeks (3 sessions/week). Final testing for balance and strength will be performed after a 6-month period; the frequency of falls will be monitored.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - T12
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 1 month
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T12
    Additionally, participants must
    be able to stand for >30 seconds without upper limb support or assistance
    require physical assistance or brace to ambulate 10 meters
    NOT have implanted device or other contraindication for FES, including radation, deep vein thrombisis, or pregnancy

    What’s involved

    Type

    Rehabilitation

    Details

    perform 18 training sessions over 6 weeks (3 sessions/week), involving: one-hour sessions of standing and/or walking exercises with reactive balance training electrical stimuli applied to the leg muscles through electrodes on the skin

    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
    • 27 Sep 2021
    • Organisation
    • University Health Network, Toronto
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 27 Sep 2021
    • Organisation
    • University Health Network, Toronto

    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