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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acute Intermittent Hypoxia
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Acute Intermittent Hypoxia, Motor Unit, Upper Extremity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute intermittent Hypoxia Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Biceps Brachii Muscle activation [μv]
Peak electromyographic activation of the biceps brachii muscle during maximum voluntary flexion and extension tasks

Full Information

First Posted
August 22, 2022
Last Updated
August 22, 2022
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT05513911
Brief Title
Intermittent Hypoxia and Upper Extremity EMG Recordings in Individuals With Spinal Cord Injury
Official Title
Intermittent Hypoxia and Upper Limb Training in Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2016 (Actual)
Primary Completion Date
November 8, 2016 (Actual)
Study Completion Date
March 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Acute Intermittent Hypoxia, Motor Unit, Upper Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Every participant in this study will receive the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute intermittent Hypoxia Therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Acute Intermittent Hypoxia
Other Intervention Name(s)
AIH
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximal Elbow Strength [Newtons]
Description
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
Time Frame
30 minutes Post intervention
Secondary Outcome Measure Information:
Title
Biceps Brachii Muscle activation [μv]
Description
Peak electromyographic activation of the biceps brachii muscle during maximum voluntary flexion and extension tasks
Time Frame
30 minutes post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Z Rymer, MD, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Milap Sandhu, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Overall participant Data will be reported in publications

Learn more about this trial

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

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