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

Shirley Ryan AbilityLab

Status: Unknown

Conditions: Spinal Cord Injuries

Treatments: Behavioral: Upper extremity training; Other: Acute Intermittent Hypoxia (AIH); Other: Sham Acute intermittent hypoxia

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03262766

81428 (Other Grant/Funding Number)

STU00204305

81349 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Motor incomplete SCI at or below C2 and above T2 with non-progressive etiology
2. Age between 18 to 70 years
3. More than 1 year since SCI
4. Ability to close and open one's hand without assistance.
5. Ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

1. Presence of any of the following medical conditions: congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, COPD/emphysema and severe asthma.
2. Weight over 250 pounds.
3. Persons with known coronary artery disease, a history of myocardial infarction and known carotid or intracerebral artery stenosis.
4. A medical clearance will be required if patients are taking any other investigational agents.
5. Women who are pregnant or nursing will be excluded, as the potential effects of intermittent hypoxia on pregnant women and fetus are unknown.
6. Individuals with tracheostomy will be excluded.
7. Subjects cannot pursue other research studies which may interfere with our treatment.
8. Subjects with diagnosed obstructive sleep apnea will be excluded as that may affect the response or sensitivity to AIH,
9. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Acute intermittent hypoxia (AIH)

Active Comparator group

Description:

Subjects will be exposed to acute intermittent hypoxia, daily for 5 days. Each session will consist of up to 90 seconds of 9-10% Oxygen (FiO2 0.09), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for up to 45 minutes, to maintain SpO2 at 80-90%. If the SpO2 drops below 75%, hypoxia exposure will be terminated immediately. There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2).

Treatment:

Other: Acute Intermittent Hypoxia (AIH)

AIH+ Upper extremity training

Experimental group

Description:

Subjects will be exposed to acute intermittent hypoxia, daily for 5 days. Each session will consist of up to 90 seconds of 9-10% Oxygen (FiO2 0.09), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for up to 45 minutes, to maintain SpO2 at 80-90%. If the SpO2 drops below 75%, hypoxia exposure will be terminated immediately. There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2). Following the AIH protocol, subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®.

Treatment:

Behavioral: Upper extremity training

Other: Acute Intermittent Hypoxia (AIH)

Sham AIH + Upper extremity training

Active Comparator group

Description:

Subjects will be exposed to sham hypoxia daily for 5 days. Each session will consist of up to 90 seconds of 21% Oxygen (FiO2 0.21), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery will be repeated up to 18 times per session each, for a total of up to 45 minutes. There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2). Following the sham AIH protocol, subjects will receive 45 minutes of task-specific, high repetition upper extremity training. Upper extremity training will be given using an upper-limb robotic rehabilitation device, the Armeo Spring®.

Treatment:

Behavioral: Upper extremity training

Other: Sham Acute intermittent hypoxia

Sham Acute intermittent hypoxia

Sham Comparator group

Description:

Subjects will be exposed to sham hypoxia daily for 5 days. Each session will consist of up to 90 seconds of 21% Oxygen (FiO2 0.21), alternating with up to 90 seconds of 21% Oxygen (normoxic air FiO2 0.21). The delivery will be repeated up to 18 times per session each, for a total of up to 45 minutes. There is continuous monitoring of respiratory rate, heart rate and peripheral arterial oxyhemoglobin saturation (SpO2).

Treatment:

Other: Sham Acute intermittent hypoxia