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Behavioural Intervention

Breathing Therapy for Spinal Cord Injury

N/A
Recruiting
Led By Emily Fox, DPT, MHS, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Incomplete SCI based on residual sensory or motor function below the level of the injury, or injury classification of B, C, D at initial screening, according to the American Spinal Injury Association Impairment Classification, and the International Standards for the Neurological Classification of SCI
Adults 18-70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and 45-60 minutes after intervention on aih day, aihh day, and sham aih day
Awards & highlights

Study Summary

This trial tests a therapy of breathing low oxygen air to stimulate spinal neuroplasticity, to see if it improves motor function after spinal cord injury. It also tests if genetics play a role.

Who is the study for?
This trial is for adults aged 18-70 with chronic spinal cord injury (SCI) at or below C-3 to T-12, who have had the condition for over a year and show some impairment in breathing strength. It's not open to those with other neurological conditions, severe pain, major illness, certain metal implants, or uncontrolled medical issues like hypertension.Check my eligibility
What is being tested?
The study tests two types of breathing treatments: AIH which uses low oxygen air and AIHH that adds slightly more carbon dioxide. Participants will also do task-specific training. The goal is to see if these can improve respiratory function after SCI and if genetics affect the outcome.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing a mask during treatment sessions and possible dizziness or shortness of breath due to changes in oxygen levels. However, specifics on side effects are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have some feeling or movement below my spinal injury.
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I am between 18 and 70 years old.
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I have had a spinal cord injury for over a year, between my neck and mid-back.
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My spinal cord injury is not getting worse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and 45-60 minutes after intervention on aih day, aihh day, and sham aih day
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and 45-60 minutes after intervention on aih day, aihh day, and sham aih day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in maximal expiratory pressure
Change in maximal inspiratory pressure
Change in motor evoked potential

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single-session testing daysExperimental Treatment3 Interventions
Participants will complete three separate single-session testing days. Baseline testing will be performed, then on each day, participants will receive AIH, AIHH, and sham AIH in random order. Post-testing will occur after each intervention.
Group II: Respiratory strength training blocksExperimental Treatment3 Interventions
Participants will complete three separate respiratory strength training blocks. In each block, participants will receive 5 days of AIH, 5 days of AIHH, and 5 days of sham AIH in random order, followed by respiratory strength training. Each block will include 5 days of intervention and training, and post-testing 1, 3, and 7 days after intervention and training has concluded.

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Who is running the clinical trial?

University of FloridaLead Sponsor
1,349 Previous Clinical Trials
719,838 Total Patients Enrolled
U.S. Army Medical Research Acquisition ActivityFED
20 Previous Clinical Trials
1,929 Total Patients Enrolled
Emily Fox, DPT, MHS, PhDPrincipal InvestigatorUniversity of Florida & Brooks Rehabilitation
~41 spots leftby Jul 2027
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