Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Spinal Cord Injuries
In brief
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 arm strength and function, and comparing it with individual treatments in persons with spinal cord injuries. The investigators hypothesize that a combinatorial intervention with AIH therapy + upper limb training will be significantly more effective in improving hand function, compared to individual treatments alone. To test this hypothesis, the investigators will determine the impact of combined daily AIH therapy and high-repetition task-specific upper extremity training on arm strength and hand dexterity in persons with spinal cord injuries.
Key facts
- Study ID
- NCT03262766
- Run by
- Shirley Ryan AbilityLab
- People needed
- 80
- Starts
- 2017-06-24
- Expected to finish
- 2020-10-30
- Last updated by the study team
- 2020-02-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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.
- 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
Where it is running
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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