Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury

NCT ID: NCT03643770

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2025-06-30

Brief Summary

Currently, there are a variety of approaches utilized in attempts to improve upper extremity function, including: traditional therapy, neuroprostheses, botulinum toxin injections, or surgical interventions. In addition, regenerative and restorative therapies, such as: epidural stimulation, functional electrical stimulation, and stem cell therapies, show promise in animal models, but are not ready for clinical translation. Subsequently, there is a clear need to develop new strategies that can stimulate spinal plasticity and strengthen existing synaptic connections in order to maximize the benefits of training paradigms.

This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in combination with upper extremity training, over the course of a month, to evaluate changes in upper extremity function, dexterity, and ability to complete activities of daily living. The use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (~21% inspired oxygen).

Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.

Detailed Description

This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in combination with upper extremity training, over the course of a month, to evaluate changes in upper extremity function, dexterity, and ability to complete activities of daily living. The use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (~21% inspired oxygen).

Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Acute Intermittent Hypoxia (AIH) treatment

The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask. The mask is designed to couple with a universal mask circuit connecting to the air mixture system. The purpose of the mask will be to minimize room air entrainment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

AIH in combination with upper extremity training

The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask. The mask is designed to couple with a universal mask circuit connecting to the air mixture system. The purpose of the mask will be to minimize room air entrainment. In addition to this upper extremity training will be given using an upper-limb robotic rehabilitation device.

Group Type: ACTIVE_COMPARATOR

Upper extremity training/Armeo Spring

Intervention Type: COMBINATION_PRODUCT

Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.

Sham AIH therapy in combination with upper extremity training

Sham hypoxia followed by upper extremity training will be given using an upper-limb robotic rehabilitation device (Armeo Spring®, Hocoma AG, Switzerland). Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.

Group Type: ACTIVE_COMPARATOR

Upper extremity training/Armeo Spring

Intervention Type: COMBINATION_PRODUCT

Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.

Sham AIH therapy

Sham hypoxia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Upper extremity training/Armeo Spring

Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• History of a non-progressive spinal cord injury, inclusive of levels of C1-T1.
• Etiology of spinal cord injury is non-progressive in nature
• Be able to demonstrate some hand muscle activation, or use of a tenodesis grasp (wrist extension)
• At least 6 months post injury
• Participants do NOT have to stop taking antispasticity medications to participate in the study.
• Must be tested for anemia with a value of at least 10g/dl (for both men and women).
• Patients will be recommended to their primary care physician to correct anemia if low levels are detected
• Blood pressure must fall within this range- high: 160/110mmHg low: 85/55 mmHg
• Must be asymptomatic (no dizziness, lightheadedness, etc)

Exclusion Criteria

• Medical conditions, including: congestive heart failure, cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known carotid/intracerebral artery stenosis.
• Women who are currently pregnant or planning on becoming pregnant
• Current tracheostomy placement
• Utilization of mechanical ventilator for breathing
• Current diagnosis of obstructive sleep apnea
• Orthopedic injuries or surgeries that would limit participation
• Concurrent participation in another research study or therapy services
• Comorbid traumatic brain injury or other neurologic injuries that would impact cognition

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Zev Rymer

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Countries

United States

Other Identifiers

CDMRP-SC160072

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU 00206035

Identifier Type: -

Identifier Source: org_study_id