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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272011
First Posted: January 7, 2011
Last Update Posted: March 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Florida
Wayne State University
Information provided by (Responsible Party):
VA Office of Research and Development
January 5, 2011
January 7, 2011
December 18, 2015
March 29, 2016
March 29, 2016
May 2010
August 2014   (Final data collection date for primary outcome measure)
Minute Ventilation - Phase 2 [ Time Frame: Pre- versus Post-treatment ]
Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects.
Minute ventilation [ Time Frame: At the end of the treatment intervention (after 2 weeks) ]
Complete list of historical versions of study NCT01272011 on ClinicalTrials.gov Archive Site
Ventilatory Loading - Phase 3 [ Time Frame: Pre- versus Post-treatment ]
Ventilatory load compensation was assessed in two ways. Mean slopes for (1) pressure vs. resistance (P vs R) and (2) airflow vs. resistance (AF vs R) were calculated for pre- and post-IH treatment.
  • Propulsion generated during stepping [ Time Frame: At the end of the treatment intervention (after 2 weeks) ]
  • Arm Swing [ Time Frame: At the end of the treatment intervention (after 2 weeks) ]
  • Volitional arm and leg movement (voluntary activation deficits) [ Time Frame: At the end of the treatment intervention (after 2 weeks) ]
Not Provided
Not Provided
 
Effects of Breathing and Walking Treatments on Recovery Post-Spinal Cord Injury
Intermittent Hypoxia and Locomotor Training: Effects Following SCI

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).

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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Spinal Cord Injuries
  • Brown Sequard
  • Central Cord Syndrome
  • Other: Intermittent Hypoxia
    Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
    Other Name: Breathing Treatment
  • Other: Locomotor Training
    Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns.
  • Experimental: Phase 1 Arm (Pilot)
    Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)
    Interventions:
    • Other: Intermittent Hypoxia
    • Other: Locomotor Training
  • Experimental: Phase 2 Arm (LTF)
    Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation
    Intervention: Other: Intermittent Hypoxia
  • Phase 3 Arm (Ventilatory Loading)
    Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.
    Intervention: Other: Intermittent Hypoxia
Tester NJ, Fuller DD, Fromm JS, Spiess MR, Behrman AL, Mateika JH. Long-term facilitation of ventilation in humans with chronic spinal cord injury. Am J Respir Crit Care Med. 2014 Jan 1;189(1):57-65. doi: 10.1164/rccm.201305-0848OC.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2014
August 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01272011
B7182-W
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
  • University of Florida
  • Wayne State University
Principal Investigator: Nicole J Tester, PhD North Florida/South Georgia Veterans Health System
VA Office of Research and Development
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP