Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT03262766

STU00204305

81428

81349

Ages 18-70
All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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.
Weight over 250 pounds.
Persons with known coronary artery disease, a history of myocardial infarction andknown carotid or intracerebral artery stenosis.
A medical clearance will be required if patients are taking any other investigationalagents.
Women who are pregnant or nursing will be excluded, as the potential effects ofintermittent 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 affectthe response or sensitivity to AIH,
Orthopedic injuries or recent surgeries affecting the mobility of upper extremity andshoulder 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

Study Design

June 24, 2017

October 30, 2020

Study 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 upper extremity function in individuals with chronic, incomplete SCI.

Previous work already determined that breathing low levels of oxygen for short periods of time (also known as acute intermittent hypoxia) can improve lower limb motor function in persons with spinal injury. Specifically, this study is being done to determine if pre-treatment with intermittent hypoxia can enhance the beneficial effects of upper limb training on the restoration of limb function in persons with spinal injury.

This is a blinded study, which means that the subject will not know which treatment they are receiving. They will either receive intermittent periods of low oxygen (hypoxia) or a session composed of only normal room air. They will be randomly assigned to a treatment based on chance. Neither the subject nor the researcher chooses the assigned group. They will have an equal chance of being in either group.

The participant will receive a daily 5-day intervention with either acute intermittent hypoxia (AIH) therapy or room air, either alone or coupled with task-specific training, on upper extremity function in individuals with chronic, incomplete SCI. This will be preceded by a baseline testing visit prior to the intervention, and followed by a 4 week follow up period to assess the effects of the interventions over time.

The total duration of participation in the study intervention protocol is 1 week. Including the follow up period, the subjects will participate for a total of 6 weeks.

Connect with a study center

Shirley Ryan AbilityLab
Chicago, Illinois 60610
United States
Active - Recruiting

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