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Clinical Trials/NCT03071393
NCT03071393
Completed
Not Applicable

Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury

University of Florida2 sites in 1 country17 target enrollmentJuly 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
University of Florida
Enrollment
17
Locations
2
Primary Endpoint
Change in Forced Vital Capacity
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2017
End Date
September 1, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Forced Vital Capacity

Time Frame: 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

Time Frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

An assessment of expiratory muscle strength.

Change in Maximal Inspiratory Pressure

Time Frame: Change between baseline and 30 minutes post-intermittent hypoxia or sham.

An assessment of inspiratory muscle strength.

Change in Mouth Occlusion Pressure (P0.1)

Time Frame: 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.

Study Sites (2)

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