Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High-Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury
Sponsor:
Shirley Ryan AbilityLab
Overview: Spinal Injury can occur from multiple situations. Spinal cord injuries may result from damage to the vertebrae, ligaments, or discs of the spinal column or to the spinal cord itself. A traumatic spinal cord injury may stem from a sudden, traumatic blow to your spine that fractures, dislocates, crushes, or compresses one or more of your vertebrae. Damage to any part of the spinal cord or nerves at the end of the spinal canal. A traumatic spinal cord injury may happen because of a sudden blow or cut to the spine. A spinal cord injury often causes permanent loss of strength, sensation, and function below the site of the injury. Rehabilitation and assistive devices allow many people with spinal cord injuries to lead productive, independent lives. Treatments include drugs to reduce symptoms and surgery to stabilize the spine. Researchers are also researching new therapeutic innovations by inviting participants to clinical trials.
There are multiple approaches utilized in attempts to improve upper extremity functions such as stem cell therapy and surgical interventions. This trial is still recruiting and in its early phase 1 stage. The objective of this study is to research 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).
Rare
Fewer than 200,000 US cases per year
Treatment can help, but this condition can’t be cured
Requires a medical diagnosis
Lab tests or imaging always required
Chronic: can last for years or be lifelong
Critical: needs emergency care
This Study is actively recruiting
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Spinal Cord Injuries |
Combination Product: Upper extremity training/Armeo Spring |
Early Phase 1 |
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Study Type : |
Interventional (Clinical Trial) |
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Estimated Enrollment : |
92 participants |
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Allocation: |
Randomized |
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Intervention Model: |
Single Group Assignment |
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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 |
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Masking: |
Double (Participant, Outcomes Assessor) |
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Primary Purpose: |
Diagnostic |
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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 |
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Actual Study Start Date : |
November 16, 2018 |
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Estimated Primary Completion Date : |
February 2023 |
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Estimated Study Completion Date : |
March 2023 |
Eligibility For Participants
- 18-75 years of age
- At least 1 year post injury
- History of a non-progressive spinal cord injury, inclusive of levels of C3-T1.
- 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)