Safety and Feasibility of TWIICE Rise

Rehabilitation
General health
Online since 19 December 2023, updated 111 days ago

About this trial

This pilot trial is enrolling 15 individuals with chronic spinal cord injuries to test the safety and feasibility of two versions of the TWIICE Rise, a lower-limb exoskeleton designed to enhance walking function. An exoskeleton is an externally worn powered robotic device to assist movement. If included, participants will undergo a training program with the exoskeleton. In the first phase, 5 participants will undergo 6 sessions for up to 6 weeks using TWIICE Rise 0 in a clinical setting. In the second phase, 10 participants will undergo 24 sessions for up to 20 weeks using an improved device, TWIICE Rise 1, in different settings (clinic, home, and community environment). Final assessment of safety and feasibility will be done after up to 26 weeks.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C5 - L5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C5-L5
    Additionally, participants must
    have a height of 160 to 180 cm (phase 1) and 160 to 190 cm (phase 2)
    NOT have a history of other severe neurological injuries
    NOT have coronary artery disease

    What’s involved

    Type

    Rehabilitation

    Details

    - Participants will undergo a training programme with one of two versions of the TWIICE Rise. - The TWIICE Rise is a lower-limb overground robotic exoskeleton designed to enhance walking function. - Phase 1: 5 participants will undergo a total of 6 sessions for up to 6 weeks in a clinic. - Phase 2: 10 participants will undergo a total of 24 sessions for up to20 weeks in different settings (clinic, home, and community environment). - Final assessment of safety and feasibility of the TWIICE Rise will be done after up to 26 weeks.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Pain

    Skin health

    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