Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol.
Study Goal
The researchers aimed to determine whether daily acute intermittent hypoxia (AIH), alone or combined with walking practice, enhances walking recovery in individuals with subacute spinal cord injury (SCI).
Results Summary
The study protocol outlines a randomized, placebo-controlled trial to assess AIH's effects on walking recovery, but results are not yet reported in the abstract. The hypothesis suggests AIH may harness endogenous plasticity mechanisms to improve walking in both ambulatory and non-ambulatory subacute SCI patients.
Population
Individuals with traumatic, subacute SCI (<12 months post-injury), stratified into non-ambulatory and ambulatory groups.
Effective Dosage
Non-ambulatory group: 15 episodes of 90s AIH at 10.0% O₂ per day; ambulatory group: same AIH protocol combined with 30 minutes of walking practice.
Duration
10 sessions over 2 weeks.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
brief episodes of low-oxygen breathing (acute intermittent hypoxia, AIH) | increase | walking recovery | persons with chronic (> 1 year) SCI | - | may serve as an effective plasticity-inducing primer that enhances the effects of walking therapy | #1 |
repetitive (weeks) AIH treatment | increase | walking recovery | persons with more acute SCI | - | More persistent walking recovery may occur | #2 |
daily exposure (10 sessions, 2 weeks) to AIH | increase | walking recovery | ambulatory and non-ambulatory persons with subacute (< 12 months) SCI | - | will enhance walking recovery | #3 |
daily AIH (15, 90s episodes at 10.0% O2) | neutral | - | non-ambulatory group | - | - | #4 |
daily AIH, alone or in combination with task-specific walking practice | increase | walking recovery | persons with traumatic, subacute SCI | - | safely promotes persistent recovery of walking | #5 |
BACKGROUND: Restoring community walking remains a highly valued goal for persons recovering from traumatic incomplete spinal cord injury (SCI). Recently, studies report that brief episodes of low-oxygen breathing (acute intermittent hypoxia, AIH) may serve as an effective plasticity-inducing primer that enhances the effects of walking therapy in persons with chronic (> 1 year) SCI. More persistent walking recovery may occur following repetitive (weeks) AIH treatment involving persons with more acute SCI, but this possibility remains unknown. Here we present our clinical trial protocol, designed to examine the distinct influences of repetitive AIH, with and without walking practice, on walking recovery in persons with sub-acute SCI (< 12 months) SCI. Our overarching hypothesis is that daily exposure (10 sessions, 2 weeks) to AIH will enhance walking recovery in ambulatory and non-ambulatory persons with subacute (< 12 months) SCI, presumably by harnessing endogenous mechanisms of plasticity that occur soon after injury. METHODS: To test our hypothesis, we are conducting a randomized, placebo-controlled clinical trial on 85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group). The non-ambulatory group receives either daily AIH (15, 90s episodes at 10.0% O DISCUSSION: The goal of this clinical trial is to reveal the extent to which daily AIH, alone or in combination with task-specific walking practice, safely promotes persistent recovery of walking in persons with traumatic, subacute SCI. Outcomes from this study may provide new insight into ways to enhance walking recovery in persons with SCI. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02632422 . Registered 16 December 2015.