Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol

BMC Neurology, 2020 · DOI: https://doi.org/10.1186/s12883-020-01851-9 · Published: July 1, 2020

Spinal Cord Injury Physiology Rehabilitation

Simple Explanation

This clinical trial aims to determine if brief, repeated exposures to low-oxygen air (acute intermittent hypoxia or AIH) can improve walking ability in people with spinal cord injuries (SCI). The study will examine if AIH, alone or combined with walking practice, can enhance walking recovery. Participants will be divided into ambulatory (able to walk) and non-ambulatory (unable to walk) groups. The non-ambulatory group will receive either AIH or a placebo (SHAM). The ambulatory group will receive walking practice (WALK), AIH + WALK, or SHAM + WALK. The primary outcomes measured will be walking speed, endurance, and balance. The study will also monitor safety measures such as pain, spasticity, blood pressure, and autonomic dysreflexia.

Study Duration

Not specified

Participants

85 study participants

Evidence Level

Level II, Randomized, placebo-controlled clinical trial

Key Findings

1
The fundamental hypothesis guiding this study is that repetitive exposure to AIH (10 sessions in 2 weeks) will enhance walking recovery in ambulatory and non-ambulatory persons with subacute SCI, presumably by augmenting neural plasticity.
2
The study aims to quantify the impact of daily AIH (alone) on restoring walking ability in persons with subacute SCI who are initially unable to walk over-ground.
3
The study also aims to determine if the benefits of daily AIH in persons with subacute SCI are without evidence of maladaptive changes and pathology.

Research Summary

This clinical trial protocol outlines a randomized, placebo-controlled study to investigate the effects of daily acute intermittent hypoxia (AIH), with or without walking practice, on walking function in individuals with subacute spinal cord injury (SCI). The study will enroll 85 participants, stratified into ambulatory and non-ambulatory groups, to receive either AIH alone, walking practice alone, AIH combined with walking practice, or a sham intervention. The primary outcome measures will assess overground walking speed, endurance, and balance, with secondary measures evaluating walking function and potential maladaptive changes such as pain and spasticity.

Practical Implications

Enhanced Walking Recovery

The study's outcomes could provide insights into enhancing walking recovery in individuals with SCI, potentially improving their functional independence and quality of life.

Clinical Utility of AIH

The results may demonstrate the clinical utility of AIH-based approaches in rehabilitation, leading to new therapeutic strategies for SCI.

Understanding Neural Plasticity

The study could provide a better understanding of how AIH influences neural plasticity within spared spinal pathways, guiding the development of targeted interventions.

Study Limitations

1
The study may be limited by recruitment challenges.
2
Potential for participant attrition could affect the statistical power of the study.
3
The generalizability of the findings may be limited by the specific inclusion and exclusion criteria.

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