Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1 and 2)

Rehabilitation
Standing/walking/mobility
Online since 3 November 2021, updated 927 days ago

About this trial

This clinical trial is enrolling individuals with chronic spinal cord injuries to test whether robotic exoskeleton walking offers health benefits, including decreased pain and spasticity, improvements in bowel and bladder function, decreased body-mass index (BMI), and enhanced well-being. The study will also measure whether using an exoskeleton improves neurological or functional recovery in participants with incomplete injuries, and also whether it improves mobility — increased walking speeds, for longer distances, and across various types of surfaces in community settings. Training will be completed over an 8-week period, consisting of three 1.5 hour walking sessions per week, for a total of 24 walking sessions. Multiple outcome assessments will be done before and after each exoskeleton training, including a follow-up session 10 weeks after the end of training to measure long-term changes.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C5 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C5-S5
    Additionally, participants must
    have a body height between 1.55 - 1.92 m (5’1” – 6’3”).
    have a body weight less than 114 kg (250 lbs).
    be non-ambulatory or poorly-ambulatory (e.g. not able to walk, or can only walk short distances with or without walking aids and primary means of mobility is a wheelchair).

    What’s involved

    Type

    Rehabilitation

    Details

    1.5 hour training sessions, 3 times a week over 8 weeks. A follow-up session 10 weeks after the end of the training phase.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bladder health/function

    Bone health

    General health

    Mental health and psychosocial factors

    Spasticity

    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
    • 15 Nov 2016
    • Organisation
    • Vanderbilt University
    • Trial recruitment status
    • Ended
    • Trial start date
    • 15 Nov 2016
    • Organisation
    • Vanderbilt 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