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

NCT03262766 | Unknown

• 3 other identifiers: STU002043058142881349
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Acute Intermittent Hypoxia; Upper Extremity Training

Outcome Measures

Primary Outcomes (1)

• Grip strength (Hydraulic Handheld Dynamometer)

  A dynamometer measures maximum gross grasp (kg) averaged over attempt with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer

  10-12 minutes

Secondary Outcomes (9)

• Pinch grip (Strength gauge Dynamometry)

  10-12 minutes

• Box and Block Test (BBT)

  5 min, with time to instruct

• Nine Hole Peg Test

  Upto 10-12 minutes, dependent on their ability to complete the test.

• Spinal Cord Independence Measure (SCIM III)

  10-15 minutes

• Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

  45-60 minutes

Study Arms (4)

Acute intermittent hypoxia (AIH)

ACTIVE COMPARATOR

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).

Other: Acute Intermittent Hypoxia (AIH)

AIH+ Upper extremity training

EXPERIMENTAL

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®.

Other: Acute Intermittent Hypoxia (AIH); Behavioral: Upper extremity training

Sham AIH + Upper extremity training

ACTIVE COMPARATOR

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®.

Behavioral: Upper extremity training; Other: Sham Acute intermittent hypoxia

Sham Acute intermittent hypoxia

SHAM COMPARATOR

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).

Other: Sham Acute intermittent hypoxia

Interventions

Acute Intermittent Hypoxia (AIH) 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; Acute intermittent hypoxia (AIH)

Upper extremity training 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.

AIH+ Upper extremity training; Sham AIH + Upper extremity training

Sham Acute intermittent hypoxia 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 AIH + Upper extremity training; Sham Acute intermittent hypoxia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60610, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• William Z Rymer, MD, PhD

  Shirley Ryan AbilityLab

  STUDY DIRECTOR

• Milap Sandhu, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milap Sandhu, PT, PhD

CONTACT

312-238-6529; m-sandhu@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a blinded study, which means the participant 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, like a flip of a coin. Neither you nor the researcher chooses your assigned group. They will have an equal chance of being in either group. Upon acceptance into the study, subjects will be assigned an identification number. Data pertaining to each subject will only be identified by this number. Any forms/files containing the subject's personal information and their ID number will be housed in a locked office/laboratory space. The outcomes assessor will also be blinded to the intervention the subject received.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: June 24, 2017
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)