Intermittent Hypoxia and Upper Extremity EMG Recordings in Individuals With Spinal Cord Injury

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Completed
CT.gov ID
NCT05513911
Collaborator
(none)
8
1
1
37.7
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Study Details

Study Description

Brief Summary

In this current study, the examiners examine some of the mechanisms of how Acute Intermittent Hypoxia (AIH) effects the upper extremity of survivors of spinal cord injury. This is accomplished both with the use of a load cell to determine elbow strength changes and high density grid electromyography (EMG) to record bicep muscle activations before and after bouts of AIH

Condition or Disease Intervention/Treatment Phase
  • Other: Acute Intermittent Hypoxia
N/A

Detailed Description

It has been shown previously that there is an increase in strength in survivors of spinal cord injury after brief bouts of Acute Intermittent Hypoxia. In this study, participants are fitted with a high density EMG electrode on the biceps brachii, and attached to a load cell at the wrist, they are asked to flex and extend their elbow at various levels of intensity. This is performed before and after the 30 minute session of AIH. The investigators hope to identify specific types of motor units of the upper extremity of survivors of spinal cord injury after AIH to help further our understanding of what mechanisms may be causing the known increase in muscle strength post AIH

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Every participant in this study will receive the interventionEvery participant in this study will receive the intervention
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intermittent Hypoxia and Upper Limb Training in Individuals With Spinal Cord Injury
Actual Study Start Date :
Feb 3, 2016
Actual Primary Completion Date :
Nov 8, 2016
Actual Study Completion Date :
Mar 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acute intermittent Hypoxia Therapy

This group will receive the acute intermittent hypoxia therapy (9% O2) for 30 minutes. Before and after the intervention the participant will perform flexion of the elbow at various levels of intensity

Other: Acute Intermittent Hypoxia
Acute Intermittent Hypoxia is administered in 30-60 second bouts of 9% O2 concentration, followed by 60-90 seconds of normoxic air concentrations (21% O2, room air). This procedure is repeated 15 times for a 30 minute session
Other Names:
  • AIH
  • Outcome Measures

    Primary Outcome Measures

    1. Maximal Elbow Strength [Newtons] [30 minutes Post intervention]

      Recordings of the elbow joint torque are taken while the participant is asked to flex and extend the elbow voluntarily at a maximum level of intensity

    Secondary Outcome Measures

    1. Biceps Brachii Muscle activation [μv] [30 minutes post intervention]

      Peak electromyographic activation of the biceps brachii muscle during maximum voluntary flexion and extension tasks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • History of Spinal Cord Injury from C3-T4

    • Non-progressive spinal cord injury

    • More than 6 months since initial Spinal Cord injury

    • Ability to understand and willingness to sign written informed consent

    Exclusion Criteria:
    • Presence of any of the following medical conditions: Congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma

    • Persons with known coronary artery disease, a history of myocardial infarction, or known carotid or intracerebral artery stenosis

    • Medical clearance will be required if participant is taking any other investigational agents

    • Women who are pregnant or nursing

    • Individuals with tracheostomy

    • Cannot pursue other research studies which may interfere

    • Unable to consent

    • Individuals who are not yet adults (infants, children, teenagers)

    • Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shirley Ryan AbilityLab Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Shirley Ryan AbilityLab

    Investigators

    • Principal Investigator: William Z Rymer, MD, PhD, Shirley Ryan AbilityLab
    • Principal Investigator: Milap Sandhu, PhD, Shirley Ryan AbilityLab

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Milap Sandhu, Principal Investigator, Shirley Ryan AbilityLab
    ClinicalTrials.gov Identifier:
    NCT05513911
    Other Study ID Numbers:
    • STU00201602
    First Posted:
    Aug 24, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Milap Sandhu, Principal Investigator, Shirley Ryan AbilityLab
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022