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FLO2 for Recovery After SCI

NCT03833674 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-05-29

No results posted yet for this study

Summary

Acute intermittent hypoxia (AIH) involves short (\~1-2min) bouts of breathing low oxygen air to stimulate spinal neuroplasticity. Studies in rodents and humans indicate that AIH improves motor function after spinal cord injury (SCI). This study will use a double blind, cross-over design to test if the combination of AIH and respiratory strength training improves breathing function more than either approach alone in adults with chronic SCI.

Conditions

  • Spinal Cord Injury (SCI)

Interventions

OTHER

Daily AIH Block

Daily sessions of AIH (dAIH) with use of short episodes of low oxygen (9% O2)

OTHER

Sham dAIH Block

Daily sessions of sham dAIH which includes breathing room air (21% O2)

OTHER

Respiratory Strength Training Block

Respiratory strength training using a hand-held device that resists inspiration or expiration.

OTHER

AIH + Strength Training Block

AIH followed by respiratory strength training.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Brooks Rehabilitation

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Emily Fox, PT, PhD · University of Florida

  • Gordon Mitchell, PhD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2024-02-20
Completion
2024-02-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03833674 on ClinicalTrials.gov