Evaluation of Usability and Human Factors in the Novus System

Technology
Standing/walking/mobility
Online since 29 October 2024, updated 88 days ago

About this trial

The Novus system intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. The pr...

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    NOT have a demand-type cardiac pacemaker, defibrillator or any electrical or metallic implant.

    What’s involved

    Type

    Technology

    Details

    The study will be carried out in two phases. Phase one (4 weeks) will focus on evaluating the usability of the Novus system. Phase two (8 weeks) will enable continued clinical follow up. The study will include sixteen (16) subjects suffering from foot drop and thigh muscles weakness due to upper motor neuron injury or disease; eight (8) subjects will be new users with no Functional Electrical Stimulation (FES) experience and the other eight (8) will be experienced Ness L300/Ness L300 Plus users. Phase two of the study will include only the new users. The primary objective of the study is to evaluate the usability of the Novus system among these patients and gain subjects' feedback regarding the device when used on a daily basis. The secondary objective is to obtain information about the performance of the system as a gait assistive device and to evaluate the subject's Quality of Life while using the system. System usability will be evaluated by adapted 5 point Likert scale usability questionnaire and patient's feedback questionnaire. Quality of life (QoL) will be measured through Participation scale questionnaire and functional ambulation assessments; modified Emory Functional Ambulation Profile (mEFAP) that will be performed with and without the system and 2 minute walk test (2MWT) with and without the system.

    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
    • Unknown
    • Trial start date
    • 1 May 2016
    • Organisation
    • Bioness Neuromodulation
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 May 2016
    • Organisation
    • Bioness Neuromodulation

    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