A Multi-Center Clinical Trial in Individuals With Spinal Cord Injury

Rehabilitation
Arm/hand function
Online since 8 November 2021, updated 834 days ago

About this trial

This trial is enrolling individuals with chronic incomplete spinal cord injuries to test usage of daily acute intermittent hypoxia (dAIH), combined with two methods of hand training (massed practice, a high number of activity repetitions; or use of a hand exoskeleton). AIH is a procedure wherein the oxygen levels of breathed air are reduced for a short duration (<2 min), alternated by exposure to room air with normal oxygen levels. Previous studies have shown that AIH is a reasonably safe and promising technique. It has been shown to influence muscle activation, within 60-120 minutes of administration. This study examines the effects of dAIH in combination with two different methods of upper extremity training: 1) dAIH and massed practice training, which addresses gross upper extremity movements, grip and pinch strength, and coordination with the goal of 300 repetitions per training session. 2) dAIH therapy and training with a virtual reality hand exoskeleton rehabilitation device (Rapael Glove). Participants will be randomly assigned to one of five groups, including: • massed practice training with dAIH • massed practice training with sham dAIH • Rapael glove with dAIH • Rapael glove with sham dAIH • no training with dAIH Participants will not be informed about their oxygen levels; the sham treatment is normal air. The study will measure changes in strength, sensation, and functional tasks in the upper extremity/hand.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C2 - T1
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    6 months - 75 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C2-T1
    Additionally, participants must
    NOT have had a botox injection to upper extremities in last 3 months

    What’s involved

    Type

    Rehabilitation

    Details

    Daily acute intermittent hypoxia (dAIH): A session takes a total of up to 45 minutes. Massed practice training or training with the Rapael Smart Glove. Participation in treatment and outcome assessments will continue for up to 3 months.

    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
    • 1 Jul 2018
    • Organisation
    • Shirley Ryan AbilityLab
    • Trial recruitment status
    • Active
    • Trial start date
    • 1 Jul 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