Nomad P-KAFO Study

Technology
General health
Online since 10 April 2023, updated 404 days ago

About this trial

The trial is enrolling individuals with neurological or neuromuscular disease (including spinal cord injuries) to test the effect of a powered knee-ankle-foot orthosis (KAFO) on walking ability. In this study, a powered KAFO (Nomad) is worn externally to assist knee movements. If included, participants will train at home with: 1) the Nomad KAFO for 3 months; and 2) their own traditional assistive device for 3 months. The order of training (Nomad first or traditional device first) will be random. Testing of walking ability, mobility, balance, frequency of falls, and quality of life will be performed after 3 months of post-training home use of each device.

Included participants

Gender
All
Age
18 - 89 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    regularly use a KAFO
    NOT have flexion contracture in the knee beyond 15 degrees
    NOT have incorrectable knee varus/valgus beyond 15 degrees

    What’s involved

    Type

    Technology

    Details

    - Home-based training with the Nomad KAFO for 3 months. - Home-based training with traditional assistive device for 3 months. - The order of training (Nomad first or traditional device first) will be random. - Final testing of walking ability will be performed 3 months after the home-based training sessions for each device.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Mental health and psychosocial factors

    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
    • Recruiting
    • Trial start date
    • 1 Mar 2024
    • Organisation
    • Shirley Ryan AbilityLab
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Mar 2024
    • 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