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

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ClinicalTrials.gov Identifier: NCT03643770
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Zev Rymer, Shirley Ryan AbilityLab

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Upper extremity training/Armeo Spring Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 4 randomized groups: Acute Intermittent Hypoxia (AIH) treatment, AIH in combination with upper extremity training, Sham AIH therapy in combination with upper extremity training and Sham AIH therapy
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
Device: Upper extremity training/Armeo Spring
Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.

Active Comparator: 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.
Device: Upper extremity training/Armeo Spring
Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.

No Intervention: Sham AIH therapy
Sham hypoxia



Primary Outcome Measures :
  1. GRASSP [ Time Frame: 4 weeks ]
    Graded Redefined Assessment of Strength, Sensation and Prehension


Secondary Outcome Measures :
  1. 9-hole peg test [ Time Frame: 4 weeks ]
    coordination

  2. grip strength [ Time Frame: 4 weeks ]
    hand strength



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of a non-progressive spinal cord injury, inclusive of levels of C3-T1.
  • Etiology of spinal cord injury is non-progressive in nature
  • Be able to demonstrate some hand muscle activation,
  • At least 1 year post injury
  • Ability to open and close at least one hand without assistance
  • At least a 10% increase in isometric elbow flexion force above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during first screening visit
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643770


Contacts
Contact: Sneha Solanki 312-238-3647 ssolanki02@sralab.org
Contact: Zev Rymer, MD zrymer@sralab.org

Sponsors and Collaborators
Shirley Ryan AbilityLab

Responsible Party: Zev Rymer, Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT03643770     History of Changes
Other Study ID Numbers: STU 00206035
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Zev Rymer, Shirley Ryan AbilityLab:
hypoxia

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Hypoxia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms, Respiratory
Signs and Symptoms