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

NCT ID: NCT03262766

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-24
• Study Completion Date: 2020-10-30

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acute intermittent hypoxia (AIH)

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).

Group Type: ACTIVE_COMPARATOR

Acute Intermittent Hypoxia (AIH)

Intervention Type: OTHER

This will consist of up to 90 seconds of 9-10% O2 (FiO2 0.09), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes.

AIH+ Upper extremity training

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®.

Group Type: EXPERIMENTAL

Acute Intermittent Hypoxia (AIH)

Intervention Type: OTHER

This will consist of up to 90 seconds of 9-10% O2 (FiO2 0.09), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes.

Upper extremity training

Intervention Type: BEHAVIORAL

Subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®. Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs. It cradles the entire arm, from shoulder to the hand, and counterbalances the weight of the user's arm. Therefore, it enhances any residual function and neuromuscular control, and assists in active movement across a large 3-D workspace. The Armeo software contains an extensive library of game-like movement exercises supported by a virtual-reality training environment that displays the functional task along with immediate performance feedback.

Sham AIH + Upper extremity training

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®.

Group Type: ACTIVE_COMPARATOR

Upper extremity training

Intervention Type: BEHAVIORAL

Subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®. Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs. It cradles the entire arm, from shoulder to the hand, and counterbalances the weight of the user's arm. Therefore, it enhances any residual function and neuromuscular control, and assists in active movement across a large 3-D workspace. The Armeo software contains an extensive library of game-like movement exercises supported by a virtual-reality training environment that displays the functional task along with immediate performance feedback.

Sham Acute intermittent hypoxia

Intervention Type: OTHER

This will consist of up to 90 seconds of 21% O2 (FiO2 0.21), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of alternating normoxic air will be repeated up to 18 times per session each, for a total of up to 45 minutes.

Sham Acute intermittent hypoxia

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).

Group Type: SHAM_COMPARATOR

Sham Acute intermittent hypoxia

Intervention Type: OTHER

This will consist of up to 90 seconds of 21% O2 (FiO2 0.21), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of alternating normoxic air will be repeated up to 18 times per session each, for a total of up to 45 minutes.

Interventions

Acute Intermittent Hypoxia (AIH)

This will consist of up to 90 seconds of 9-10% O2 (FiO2 0.09), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes.

Intervention Type: OTHER

Upper extremity training

Subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®. Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs. It cradles the entire arm, from shoulder to the hand, and counterbalances the weight of the user's arm. Therefore, it enhances any residual function and neuromuscular control, and assists in active movement across a large 3-D workspace. The Armeo software contains an extensive library of game-like movement exercises supported by a virtual-reality training environment that displays the functional task along with immediate performance feedback.

Intervention Type: BEHAVIORAL

Sham Acute intermittent hypoxia

This will consist of up to 90 seconds of 21% O2 (FiO2 0.21), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of alternating normoxic air will be repeated up to 18 times per session each, for a total of up to 45 minutes.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Milap Sandhu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Z Rymer, MD, PhD

Role: STUDY_DIRECTOR

Shirley Ryan AbilityLab

Milap Sandhu, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Milap Sandhu, PT, PhD

Role: CONTACT

m-sandhu@northwestern.edu

312-238-6529

Facility Contacts

Milap Sandhu, PT, PhD

Role: primary

m-sandhu@northwestern.edu

312-238-6529

Other Identifiers

81428

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

81349

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU00204305

Identifier Type: -

Identifier Source: org_study_id