Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03643770 |
| Other study ID # |
STU 00206035 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2018 |
| Est. completion date |
July 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Shirley Ryan AbilityLab |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
