Safety and Feasibility of TWIICE Rise

Rehabilitation
General health
Online since 30 August 2023, updated 21 days ago

About this trial

The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury. This study is done in two p...

Included participants

Gender
All
Age
18 - 70 years
Injury level
C5 - L5
  • Severity (AIS)?
  • Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C5-L5

    What’s involved

    Type

    Rehabilitation

    Details

    The aim of this clinical trial is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton assisted ambulation in patients with a spinal cord injury. The study is thus done in two phases. The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with five patients over 6 sessions in clinic. This phase allows the manufacturer to collect data that can be used to improve the device design if necessary. The second phase of the study is being conducted with TWIICE Rise 1.0. Safety and feasibility will be assessed with 10 patients over 24 sessions in different settings (clinic, home, and community environment) to test the device intended use. The first sessions are done at the rehabilitation specialized center to benefit from the clinical settings to learn to walk with the exoskeleton. Once the patients reach sufficient ambulatory skills determined by a score of 29 in the Mobility SkillsTests, the following sessions can be done at home and community settings.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Pain

    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
    • 25 Jul 2023
    • Organisation
    • TWIICE
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 25 Jul 2023
    • Organisation
    • TWIICE

    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