Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs

Online since 12 September 2023, updated 218 days ago

About this trial

The loss of standing and walking capabilities in a paraplegic person is most often the result of damage to the spinal cord, either traumatic (accidental) or pathological and has both a somatic and a p...

Included participants

Gender
All
Age
18 - 60 years
Injury level
Level not specified
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    Level not specified

    What’s involved

    Type

    Observational

    Details

    The aim of this study was to test the use of the Atalante exoskeleton on 10 patients with complete motor paraplegia (ASIA A and B) with a level of injury between T6 and S1. In this multi-centric clinical trial, patients were asked to perform between 1 and 2 days of training with Atalante exoskeleton including device training and evaluations (up to 9 hours of training and 3 hours of evaluation per patient). The primary objective of this study was to assess patients' ability to walk straight- for 10 meters with the Atalante exoskeleton during 10-meters walk test (10MWT). Within-group differences between the Atalante exoskeleton and the usual walking aid used by the patient in the success rate of the 10MWT were compared by a McNemar test. The secondary objectives focused on performance evaluation with the Atalante exoskeleton. The assessments performed were: Assessment of the superiority of the Atalante exoskeleton compared to the usual aid walking assistance used by the patient on the walking, verticalization (or sit-to-stand), static and dynamic balance ability Assessment of the static and dynamic postural stability of the subject with the Atalante exoskeleton by observation of center of pressure displacement and velocity Assessment of the perceived effort by the patient Assessment of perceived safety by the patient Assessment of the overall satisfaction of patients after using the exoskeleton Comparison of the two types of walk on walking ability, perceived effort, and safety

    Potential 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
    • Ended
    • Trial start date
    • 9 Dec 2016
    • Organisation
    • Wandercraft
    • Trial recruitment status
    • Ended
    • Trial start date
    • 9 Dec 2016
    • Organisation
    • Wandercraft

    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