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NCT03643770 · ClinicalTrials.gov registry record · Early Phase 1
Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury
A Early Phase 1 study, sponsored by Shirley Ryan AbilityLab.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 58
- Enrollment target
NCT03643770 is a Early Phase 1 study that has completed, run by Shirley Ryan AbilityLab. The registered enrollment target is 58 participants.
The verdict
NCT03643770, a Early Phase 1 study, has completed, sponsored by Shirley Ryan AbilityLab.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 58 participants
- Enrollment target
Study 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.
Interventions
- COMBINATION_PRODUCT Upper extremity training/Armeo Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2018-11-16 |
| Est. Completion | 2025-06-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03643770
The ClinicalTrials.gov registry entry for NCT03643770 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shirley Ryan AbilityLab, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Upper extremity training/Armeo Spring is the first listed.
NCT03643770 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03643770 about?
NCT03643770 is a clinical study titled "Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury". 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, functiona...
What is the current status of trial NCT03643770?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 58 participants. The study started on 2018-11-16. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT03643770?
The interventions under investigation include: Upper extremity training/Armeo Spring (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03643770?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
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