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Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

Rehabilitation
Standing/walking/mobility
Online since 8 November 2021, updated 1139 days ago
Curated trial

About this trial

This trial is recruiting individuals with incomplete spinal cord injuries to test the effect of an externally worn robotic device (powered exoskeleton; PE) to assist overground walking training (OLTP). The exoskeleton will be used in combination with a technique that applies electrical stimulation through the skin to nerves (functional electrical stimulation; FES). Participants will be randomly assigned to one of three interventions groups that will include OLTP/PE alone or combined with either FES or sham FES. Evaluations will include walking speed and function, plus changes in pain, spasticity and other secondary conditions of SCI.

Included participants

Gender
All
Age
18 - 64 years
Injury level
C1 - S5
  • Severity (AIS)?
    • AIS-B
    AIS-C
    AIS-D
    Time since injury
    3 days - 6 months
  • Injury type

    • Traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    be actively participating in intensive functional rehabilitation in the SCI program of the Institut de réadaptation en déficience physique de Québec
    be able to stand for more than 30 minutes.
    measure between 5'1" and 6'3" (1.50-1.90m).

    What’s involved

    Type

    Rehabilitation

    Details

    If included, the participant will receive one of the following: first 12 sessions of OLTP/PE + FES (4-6 weeks), then another 12 sessions of OLTP/P + shamFES (4-6 weeks), or first 12 sessions of OLTP/PE + shamFES (4-6 weeks), then another 12 sessions of OLTP/P + FES (4-6 weeks), or 24 sessions of OLTP/PE without FES (8-12 weeks). All participants will be re-evaluated at 3 months.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    Pain

    Spasticity

    Mechanism of action

    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
    • 10 Dec 2020
    • Organisation
    • Laval University
    View on clinicaltrials.gov
    for more details
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 10 Dec 2020
    • Organisation
    • Laval University
    View on clinicaltrials.gov
    for more details

    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

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