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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05513911
Other study ID # STU00201602
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2016
Est. completion date March 25, 2019

Study information

Verified date August 2022
Source Shirley Ryan AbilityLab
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date March 25, 2019
Est. primary completion date November 8, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Shirley Ryan AbilityLab Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal Elbow Strength [Newtons] 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 30 minutes Post intervention
Secondary Biceps Brachii Muscle activation [µv] Peak electromyographic activation of the biceps brachii muscle during maximum voluntary flexion and extension tasks 30 minutes post intervention
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