TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia.

Technology
Arm/hand function
Online since 6 July 2022, updated 642 days ago

About this trial

This is a usability trial to test a home-use device (called Tetragrip II) that delivers functional electrical stimulation (FES) for hand function after cervical spinal cord injury. FES is a technique that applies electrical stimulation through the skin to nerves to activate weakened or paralyzed muscles. This study will investigate the Tetragrip II that is being developed for use in the home without clinical supervision, for hand and arm movements in people with tetraplegia. If included, the participant will complete 10 weeks of Tetragrip II training in the clinic, followed by 8 weeks of unsupervised home use.

Included participants

Gender
All
Age
0 - 90 years
Injury level
C4 - C7
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 90 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C4-C7
    Additionally, participants must
    NOT have shoulder pain
    NOT have an implanted device such as cardiac pacemaker, defibrillator, etc.
    NOT known to suffer from significant autonomic dysreflexia in response to FES

    What’s involved

    Type

    Technology

    Details

    - Electrodes attached to the hand, arm and shoulder in order to activate muscles and record their activity. - Gradually increasing daily hand/arm/shoulder exercises in the clinic from 30 to 60 minutes, with and without the device, over a 4 week period - Testing of upper extremity function before clinical training (i.e. baseline) and after 10 weeks of Tetragrip II training in the clinic. - Testing of upper extremity function after 8 weeks (e.g. week 18) of unsupervised home-use of Tetragrip II.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    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
    • 26 Oct 2021
    • Organisation
    • Bournemouth University
    • Trial recruitment status
    • Ended
    • Trial start date
    • 26 Oct 2021
    • Organisation
    • Bournemouth University

    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