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

Spinal Cord Injuries Clinical Trial

Official title:

Intermittent Hypoxia and Upper Limb Training in Individuals With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05513911
• Other study ID #: STU00201602
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hypoxia
• Spinal Cord Injuries
• Wounds and Injuries

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