C-Brace II Spinal Cord Injury

Technology
Standing/walking/mobility
Online since 4 November 2021, updated 926 days ago

About this trial

This trial is enrolling individuals with spinal cord injuries to test a new knee-ankle-foot orthosis (KAFO) and its effect on walking function. Traditionally, KAFOs are used to support unstable walking (gait) during the rehabilitation process. The C-Brace II KAFO is controlled by a micro-processor. If selected for the study, participants will randomly be assigned to one of two groups, using either a traditional KAFO or the C-Brace II. The functional outcome differences over a 3-month home trial will be analyzed between the two devices. Measurements will include walking speed, balance, muscle strength, and muscle spasticity.

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    3 months - 24 months
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    require orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally.
    have a body weight lower than 275 lbs (=125 kg).

    What’s involved

    Type

    Technology

    Details

    3-6 orthoses sessions for clinical evaluation and fitting. 10-20 one-hour training sessions over 1-2 months in the lab. Fine-tuning to the needs and preferences. First training sessions. Home-use for a 3-month period, with an activity-monitor. Outcome assessments at 3, 6, 12 months after receiving the brace for testing.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bladder health/function

    General health

    Mental health and psychosocial factors

    Spasticity

    Mechanism of action

    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
    • 16 Apr 2019
    • Organisation
    • Shirley Ryan AbilityLab
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 16 Apr 2019
    • Organisation
    • Shirley Ryan AbilityLab

    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