Intermittent Hypoxia and Upper Extremity EMG Recordings in Individuals With Spinal Cord Injury
1 other identifier
interventional
8
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2019
CompletedFirst Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedAugust 24, 2022
August 1, 2022
9 months
August 22, 2022
August 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Biceps Brachii Muscle activation [μv]
30 minutes post intervention
Study Arms (1)
Acute intermittent Hypoxia Therapy
EXPERIMENTALThis 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Z Rymer, MD, PhD
Shirley Ryan AbilityLab
- PRINCIPAL INVESTIGATOR
Milap Sandhu, PhD
Shirley Ryan AbilityLab
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 24, 2022
Study Start
February 3, 2016
Primary Completion
November 8, 2016
Study Completion
March 25, 2019
Last Updated
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
Overall participant Data will be reported in publications