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

This study is currently recruiting participants.
Verified January 2013 by Department of Veterans Affairs
Sponsor:
Collaborators:
University of Florida
Wayne State University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01272011
First received: January 5, 2011
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention
Spinal Cord Injuries
Brown Sequard
Central Cord Syndrome
 Other: Breathing (Hypoxia) Treatment
Other: Breathing (Hypoxia) Treatment and Locomotor Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Intermittent Hypoxia and Locomotor Training: Effects Following SCI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Minute ventilation [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Propulsion generated during stepping [ Time Frame: At the end of the treatment intervention (after 2 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: May 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Those exposed to hypoxia with elevated levels of carbon dioxide
 Other: Breathing (Hypoxia) Treatment
Hypoxia (breathing 1/3 less oxygen than what is present in normal room air) versus non hypoxia will be compared to determine whether respiratory drive can be increased following spinal cord injury.
Experimental: Arm 2
Those exposed to hypoxia and locomotor training
 Other: Breathing (Hypoxia) Treatment and Locomotor Training
Comparison of the effect of locomotor training with versus without a breathing (hypoxia) treatment. Individuals will be randomized to receiving hypoxia or normal room air. They will receive either the experimental or placebo comparator (whichever they were randomized to) preceding the locomotor training. All individuals, however, will receive locomotor training.
Placebo Comparator: Arm 3
Those exposed to a placebo breathing treatment (breathing normal room air rather than hypoxia) and locomotor training
 Other: Breathing (Hypoxia) Treatment and Locomotor Training
Comparison of the effect of locomotor training with versus without a breathing (hypoxia) treatment. Individuals will be randomized to receiving hypoxia or normal room air. They will receive either the experimental or placebo comparator (whichever they were randomized to) preceding the locomotor training. All individuals, however, will receive locomotor training.

Detailed Description:

Spinal cord injury (SCI) is a very disabling health problem. Paralysis and paresis of limb and trunk muscles are major consequences of SCI and result in the inability to walk or difficulty walking. The most commonly stated goal by individuals with SCI during rehabilitation is the desire to walk again. Locomotor training (LT) that uses a body-weight support system and treadmill (BWST) is a task-specific rehabilitation intervention that allows practice of walking at normal speeds while loading the lower extremities, facilitating upright posture, and hip extension. Substantial improvement in ambulation can occur following locomotor training (LT) in individuals with motor incomplete spinal cord injury (iSCI). Despite these advances in activity-dependent rehabilitation, a need exists for defining complementary strategies that further amplify endogenous neuroplasticity. The proposed study will assess the therapeutic potential of (1) a respiratory training intervention (acute intermittent hypoxia, or AIH) on breathing function and (2) a combined locomotor (LT) and respiratory (AIH) training intervention for enhancing walking recovery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 at C3 or below (and above T12, 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272011

Contacts
Contact: Nicole Tester, PhD (352) 376-1611 ext 7507 Nicole.Tester@va.gov
Contact: Carolyn Hanson, PhD (352) 376-1611 ext 5110 carolyn.hanson@va.gov

Locations
United States, Florida
North Florida/South Georgia Veterans Health System Recruiting
Gainesville, Florida, United States, 32608
Contact: Nicole Tester, PhD     352-376-1611 ext 7507     Nicole.Tester@va.gov    
Principal Investigator: Nicole Tester, PhD            
Sponsors and Collaborators
Department of Veterans Affairs
University of Florida
Wayne State University
Investigators
Principal Investigator: Nicole Tester, PhD North Florida/South Georgia Veterans Health System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01272011     History of Changes
Other Study ID Numbers: B7182-W
Study First Received: January 5, 2011
Last Updated: January 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Respiration
Spinal cord injuries
Walking recovery

Additional relevant MeSH terms:
Retinitis Pigmentosa
Spinal Cord Injuries
Central Cord Syndrome
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
 Retinal Diseases
Genetic Diseases, Inborn
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013