Clinical trial NCT03262766: Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI
Official title: Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Acute Intermittent Hypoxia
Upper Extremity Training
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2017-08-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Subjects will then be randomized to one of the four arms. The four arms of interventions are:

1. Acute intermittent hypoxia (AIH) therapy
2. AIH therapy + Upper extremity training
3. Sham AIH therapy + Upper extremity training
4. Sham Hypoxia
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Grip strength (Hydraulic Handheld Dynamometer)
timeFrame: 10-12 minutes
Secondary outcomes:
measure: Pinch grip (Strength gauge Dynamometry)
timeFrame: 10-12 minutes
measure: Box and Block Test (BBT)
timeFrame: 5 min, with time to instruct
measure: Nine Hole Peg Test
timeFrame: Upto 10-12 minutes, dependent on their ability to complete the test.
measure: Spinal Cord Independence Measure (SCIM III)
timeFrame: 10-15 minutes
measure: Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
timeFrame: 45-60 minutes
measure: Capabilities of Upper Extremity Questionnaire
timeFrame: 10 minutes
measure: California Verbal Learning Test
timeFrame: 45 minutes
measure: Delis-Kaplan Executive Function System (D-KEFS™)
timeFrame: 10-12 minutes
measure: N-back test
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: William Z Rymer, MD, PhD
role: STUDY_DIRECTOR
affiliation: Shirley Ryan AbilityLab
name: Milap Sandhu, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: