Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury

Rehabilitation
Arm/hand function
Online since 8 November 2021, updated 883 days ago

About this trial

This trial is recruiting individuals with chronic incomplete cervical (neck area) spinal cord injuries to test the safety and possible effect of acute intermittent hypoxia (AIH) in combination with arm and hand training. AIH is a procedure wherein the oxygen levels of breathed air are reduced for a short duration (less than 2 min), alternated by exposure to room air with normal oxygen levels. Previous studies have shown that AIH is safe and effective; a recent study showed that coupling AIH with overground gait (walking) training increased walking endurance and walking speed. If selected for the trial, participants will be assigned to one of four groups: 1) AIH treatment with upper extremity training (using the Armeo Spring device, a gravity support system based on an ergonomic arm exoskeleton with integrated springs); 2) AIH treatment without upper extremity training; 3) sham AIH with upper extremity Armeo training; 4) sham AIH without upper extremity training. Participants will not know about their level of oxygen, which is provided via mask. Sham AIH uses room air. The latter three groups will serve as controls for the AIH treatment with upper extremity training. This study will measure changes in upper extremity function, dexterity, and ability to complete activities of daily living.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C3 - T1
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    1 year - 75 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C3-T1
    Additionally, participants must
    NOT be dependent on a ventilator

    What’s involved

    Type

    Rehabilitation

    Details

    Acute intermittent hypoxia in combination with upper extremity training, over the time course of a month. There is no planned follow-up assessment.

    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
    • Active
    • Trial start date
    • 16 Nov 2018
    • Organisation
    • Shirley Ryan AbilityLab
    • Trial recruitment status
    • Active
    • Trial start date
    • 16 Nov 2018
    • Organisation
    • Shirley Ryan AbilityLab

    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