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

This study has been completed.
Sponsor:
Collaborators:
University of Florida
Wayne State University
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01272011
First received: January 5, 2011
Last updated: February 26, 2016
Last verified: February 2016
  Purpose

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).


Condition Intervention
Spinal Cord Injuries
Brown Sequard
Central Cord Syndrome
Other: Intermittent Hypoxia
Other: Locomotor Training

Study Type: Interventional
Study Design: Allocation: Non-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:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Minute Ventilation - Phase 2 [ Time Frame: Pre- versus Post-treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Ventilatory Loading - Phase 3 [ Time Frame: Pre- versus Post-treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: May 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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 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
Other: Intermittent Hypoxia
Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
Other Name: Breathing Treatment
Phase 3 Arm (Ventilatory Loading)
Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.
Other: Intermittent Hypoxia
Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
Other Name: Breathing Treatment

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   (Adult, Senior)
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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272011

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
VA Office of Research and Development
University of Florida
Wayne State University
Investigators
Principal Investigator: Nicole J Tester, PhD North Florida/South Georgia Veterans Health System
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01272011     History of Changes
Other Study ID Numbers: B7182-W 
Study First Received: January 5, 2011
Results First Received: December 18, 2015
Last Updated: February 26, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Respiration
Spinal cord injuries
Walking recovery

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Central Cord Syndrome
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 26, 2016