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Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury

NCT02274116 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-20

No results posted yet for this study

Summary

The purpose of this study is to determine how the nervous system controlling leg muscles is altered following spinal cord injury and how they may be affected by brief periods of low oxygen inhalation over time.

The investigators hypothesize:

* Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength in persons with incomplete cervical spinal cord injury (SCI)
* AIH exposure will increase multijoint reflex excitability of leg muscles in persons with incomplete cervical SCI
* AIH exposure will increase walking performance in persons with incomplete cervical SCI

Conditions

  • Spinal Cord Injuries

Interventions

OTHER

SHAM - Intermittent Room Air - room air mixture

Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.21±0.02 (normoxia). Participants will receive treatment 5 times per week for 2 weeks.

OTHER

AIH - Intermittent Hypoxia - hypoxia air mixture

Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.10±0.02 (hypoxia). Participants will receive treatment 5 times per week for 2 weeks.

Sponsors & Collaborators

  • Foundation Wings For Life

    collaborator OTHER

  • Spaulding Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Randy D Trumbower, PT, PhD · Spaulding Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2027-08-31
Completion
2027-11-30

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 NCT02274116 on ClinicalTrials.gov