ACTive Exoskeleton for Unilaterally-Assisted Locomotion (ACTUAL)

Rehabilitation
Standing/walking/mobility
Online since 2 January 2024, updated 59 days ago

About this trial

Walking difficulties are common symptoms after stroke, significantly reducing quality of life. Walking recovery is therefore one of the main priorities of rehabilitation. Wearable powered exoskeletons...

Included participants

Gender
All
Age
30 - 75 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    Yes
    C1-S5

    What’s involved

    Type

    Rehabilitation

    Details

    The aim of the study was to identify the end-users needs and to develop a user-centered-based control system for the TWIN lower limb exoskeleton to provide post-stroke rehabilitation. The investigators thus carry out the development and validation of TWIN-Acta: a novel control suite for TWIN, specifically designed for gait rehabilitation of persons post stroke through use of typical physiological movement patterns. The study will be carried out in two phases. In the first user-centered developmental phase data on usability, acceptability, and limitations to system usage will be collected from clinical experts and persons with stroke through questionnaires and semi-structured interviews.This developmental phase will follow a user-centered approach: it will be based on focus group sessions with clinical and biomechanical experts to define the design specifications for the new control modality of the exoskeleton; consequently evaluation sessions consisting of physical testing of the TWIN-Acta will be carried out by healthy clinical experts and persons with stroke to evaluate TWIN-Acta usability, acceptability, and barriers of usage. In the second phase of the study a pilot study including 20 sessions of gait rehabilitation of persons at least three month post stroke will be carried out in clinic with the TWIN exoskeleton including the TWIN-Acta control suite. Outcomes will be verified at baseline and following the intervention through feasibility measures, patient reported outcomes, clinical measures of gait ability and through EMG and 3D gait analysis. The quantitative values will be compared to data of healthy controls walking in the exoskeleton in one session but not receiving any intervention.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    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
    • 12 Apr 2021
    • Organisation
    • Fondazione Don Carlo Gnocchi Onlus
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 12 Apr 2021
    • Organisation
    • Fondazione Don Carlo Gnocchi Onlus

    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