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临床试验/NCT03071393
NCT03071393已完成不适用

Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

University of Florida4 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
4
主要终点
Change in Forced Vital Capacity

研究概览

简要总结

This study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. This information may be useful in advancing rehabilitation for people with spinal cord injuries.

详细描述

Recent evidence has shown that acute intermittent hypoxia can strengthen motor pathways after spinal cord injury, and enhance walking outcomes after walking rehabilitation compared to walking rehabilitation alone. A single session of acute intermittent hypoxia has also been shown to temporarily enhance breathing and limb strength in people with spinal cord injury. Further evidence supports the hypothesis that acute intermittent hypoxia acts on all motor pathways, and thus can enhance the strength of most muscles in the body.

Spinal cord injury affects the muscles that control respiration. Decreased respiratory muscle function can lead to diseases of the respiratory system, which are the primary cause of death and significant cause of re-hospitalization after spinal cord injury. Deficits in postural muscle function affect one's ability to balance, safely maintain a seated position, or ambulate after spinal cord injury, severely impacting daily activities such as self-care and feeding skills.

This study will test the hypothesis that a single session of acute intermittent hypoxia will increase strength and activation of the muscles that control respiration and posture, leading to improved scores on functional assessments in individuals with chronic spinal cord injury. Our long term goal is to better understand the therapeutic potential of acute intermittent hypoxia combined with physical rehabilitation for individuals with chronic spinal cord injury.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Subjects will be asked to participate in two visits at least 7 days apart. Subjects will be assessed on various clinical outcomes before and after an exposure to one of two treatments. In one visit, subjects will be assessed before and after acute intermittent hypoxia, consisting of brief exposures of breathing low oxygen air, alternated with brief exposures to room air. In the other visit, subjects will be assessed before and after an exposure to a sham treatment, consisting of breathing brief exposures of normal oxygen air, alternated with brief exposures to room air. Subjects will undergo acute intermittent hypoxia or a sham treatment in a randomized order.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Forced Vital Capacity

时间窗: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.

Change in Maximal Expiratory Pressure

时间窗: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

An assessment of expiratory muscle strength.

Change in Maximal Inspiratory Pressure

时间窗: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

An assessment of inspiratory muscle strength.

Change in Mouth Occlusion Pressure (P0.1)

时间窗: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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