Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI

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

About this trial

This is a trial to test the effect of repeatedly breathing air with low oxygen content for brief periods, alternating with breathing room air with normal oxygen content (acute intermittent hypoxia: AIH) in combination with training on arm strength and function. If included in this trial, the participant will undergo a 5-day intervention with either 1) a 45 minute session of AIH alone, 2) 45 minute session of AIH followed by 45 minutes of arm training, 3) a 45 minute inactive intervention session (sham AIH: breathing normal room air) alone - not intended to have a therapeutic effect - used in a controlled trial for comparison to an active intervention, or 4) a 45 minute session of sham AIH followed by a 45 minute arm training. The study takes a total of 6 weeks, including initial tests (3-4 hours) before the intervention and final tests for 4 weeks after the intervention.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C2 - T1
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    1 year - 70 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C2-T1
    Additionally, participants must
    have a spinal cord injury for at least 1 year.
    have a neurological level of injury between C2 and T1.
    have one of the following ASIA impairment scale (AIS):

    What’s involved

    Type

    Observational

    Details

    Study participation lasts a total of 6 weeks, including 1) 3-4 hours of initial tests (i.e., arm strength, manual dexterity, etc.) before the intervention, 2) the intervention and 3) final tests for 4 weeks after the intervention. The intervention includes a 5-day intervention with either 1) a 45 minute session of AIH alone, 2) 45 minute session of AIH followed by 45 minutes of arm training, 3) a 45 minute inactive intervention session (sham AIH: breathing normal room air) alone - not intended to have a therapeutic effect - used in a controlled trial for comparison to an active intervention, or 4) a 45 minute session of sham AIH followed by a 45 minute arm training. Participants will be randomly assigned to one of four described treatment arms. Neither the participants nor the outcome assessor will know the assigned (AIH vs sham AIH) intervention.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Standing/walking/mobility

    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
    • 24 Jun 2017
    • Organisation
    • Shirley Ryan AbilityLab
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 24 Jun 2017
    • 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