Effects of Breathing and Walking Treatments on Recovery Post-Spinal Cord Injury

Completed · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injuries, Brown Sequard, Central Cord Syndrome

In brief

Change to Reflect What Was Done and reason Changes Were Made. The purpose of this study is to determine (1) if a specific breathing treatment (intermittent hypoxia) can promote changes in breathing function and (2) if pairing breathing treatments (hypoxia) with locomotor training can enhance the benefits of walking recovery observed with locomotor training alone (without breathing treatments).

Key facts

Study ID

NCT01272011

Run by

VA Office of Research and Development

People needed

16

Starts

2010-05-01

Expected to finish

2014-08-01

Last updated by the study team

2016-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults at least 18 years of age
• At least 12 months post-incomplete spinal cord injury (I-SCI), including but not limited to the following syndromes: Brown Sequard and Central Cord Syndromes
• Upper motor neuron lesion (with upper motor neuron signs (i.e. presence of clonus, spasms, and/or hyperreflexia))
• A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
• Resting oxygen saturation (SpO2) levels of 95-99%
• Individuals who ambulate independently, with an assistive device, or who can walk when provided manual assistance
• Persons using anti-spasticity medication must maintain stable medication dosage during the study
• Able to give informed consent.
• Medical approval by individual's physician

You may not qualify if…

• Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study
• History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Frederich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol
• Inappropriate or unsafe fit of the harness due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality.
• Severe spasticity that would prohibit the safe provision of training.
• Pregnancy - all women of childbearing age will be required to undergo pregnancy testing prior to enrollment
• Unstable medical condition that could interfere with safety during participation in study (i.e. symptomatic cardiopulmonary complication, osteoporosis, contractures or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with a training protocol)

Where it is running

• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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