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Comparing Digitally and Traditionally Made Ankle Foot Orthoses

Technology
Standing/walking/mobility
Online since 4 September 2025, updated 7 days ago
Curated trial

About this trial

This trial is enrolling 50 participants with mobility impairments due to conditions such as spinal cord injury or stroke to test the feasibility of 3D-printed ankle-foot orthoses (AFOs) compared to tradtional AFOs manually fabricated from a plaster cast of the participant's leg. AFOs are devices used to support the lower limbs during walking. If included, participants will be randomly assigned to wear either traditional or digital AFOs first for 3 weeks, then switch to the other type for another 3 weeks. This is followed by an 8-week long-term wear period with one randomly assigned AFO type. Final assessment of feasibility will be performed after 14 weeks.

Included participants

Gender
All
Age
≥ 8 years
Injury level
C1 - S5
  • Severity (AIS)?
    • Time since injury
    All
    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    Require the use of an AFO to improve physical functioning
    Be able to ambulate independently
    Meet requirements for AFO funding by the Assistive Device Program in Ontario, Canada

    What’s involved

    Type

    Technology

    Details

    - Participants will be randomly assigned to wear either traditional or digital ankle-foot orthoses (AFOs) first for 3 weeks, then switch to the other type for another 3 weeks. This is followed by an 8-week long-term wear period with one randomly assigned AFO type. - AFOs are devices used to support the lower limbs during walking. - Final assessment of feasibility will be performed after 14 weeks.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    Mental health and psychosocial factors

    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 Mar 2025
    • Organisation
    • Holland Bloorview Kids Rehabilitation Hospital
    View on clinicaltrials.gov
    for more details
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Mar 2025
    • Organisation
    • Holland Bloorview Kids Rehabilitation Hospital
    View on clinicaltrials.gov
    for more details

    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

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