N/A
N=16
Effects of Breathing and Walking Treatments on Recovery Post-Spinal Cord Injury
Spinal Cord Injuries · Brown Sequard · Central Cord Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01272011 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Minute Ventilation - Phase 2 — 22.0; 18.6; 22.0; 22.1 percentage of baseline — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intermittent Hypoxia (Other); Locomotor Training (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minute Ventilation - Phase 2 |
22.0; 18.6; 22.0; 22.1 | <0.001 sig |
| SECONDARY Ventilatory Loading - Phase 3 |
-0.12; -0.17; -0.003; -0.0004 | <0.05 sig |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01272011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.