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

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

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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Acute Intermittent Hypoxia

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan Abilitylab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biceps Brachii Muscle activation [μv]	Peak electromyographic activation of the biceps brachii muscle during maximum voluntary flexion and extension tasks	30 minutes post intervention

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Investigators: Principal Investigator: William Z Rymer, MD, PhD, Shirley Ryan Abilitylab; Principal Investigator: Milap Sandhu, PhD, Shirley Ryan Abilitylab

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2016
• Primary Completion (Actual): November 8, 2016
• Study Completion (Actual): March 25, 2019

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Upper Extremity; Acute Intermittent Hypoxia; Motor Unit
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Signs and Symptoms, Respiratory; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Hypoxia
• Other Study ID Numbers: STU00201602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Overall participant Data will be reported in publications

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No