Status:
UNKNOWN
Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this research study is to investigate the effectiveness of a combinatorial therapy of breathing low oxygen in short bursts-acute intermittent hypoxia (AIH) and upper limb training on ar...
Detailed Description
The objective of this research project is to determine the effect of a 5-day intervention with daily acute intermittent hypoxia (AIH) therapy, either alone or coupled with task-specific training, on u...
Eligibility Criteria
Inclusion
- Motor incomplete SCI at or below C2 and above T2 with non-progressive etiology
- Age between 18 to 70 years
- More than 1 year since SCI
- Ability to close and open one's hand without assistance.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- Presence of any of the following medical conditions: congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma.
- Weight over 250 pounds.
- Persons with known coronary artery disease, a history of myocardial infarction and known carotid or intracerebral artery stenosis.
- A medical clearance will be required if patients are taking any other investigational agents.
- Women who are pregnant or nursing will be excluded, as the potential effects of intermittent hypoxia on pregnant women and fetus are unknown.
- Individuals with tracheostomy will be excluded.
- Subjects cannot pursue other research studies which may interfere with our treatment.
- Subjects with diagnosed obstructive sleep apnea will be excluded as that may affect the response or sensitivity to AIH,
- Orthopedic injuries or recent surgeries affecting the mobility of upper extremity and shoulder
- We will not include the following populations:
- Adults unable to consent, unless accompanied by a legally authorized representative.
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Key Trial Info
Start Date :
June 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03262766
Start Date
June 24 2017
End Date
October 30 2020
Last Update
February 19 2020
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60610