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

Primary Purpose

Spinal Cord Injuries, Brown Sequard, Central Cord Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Hypoxia
Locomotor Training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Respiration, Spinal cord injuries, Walking recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Phase 1 Arm (Pilot)

Phase 2 Arm (LTF)

Phase 3 Arm (Ventilatory Loading)

Arm Description

Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)

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

Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.

Outcomes

Primary Outcome Measures

Minute Ventilation - Phase 2
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
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.

Full Information

First Posted
January 5, 2011
Last Updated
February 26, 2016
Sponsor
VA Office of Research and Development
Collaborators
University of Florida, Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT01272011
Brief Title
Effects of Breathing and Walking Treatments on Recovery Post-Spinal Cord Injury
Official Title
Intermittent Hypoxia and Locomotor Training: Effects Following SCI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Florida, Wayne State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Brown Sequard, Central Cord Syndrome
Keywords
Respiration, Spinal cord injuries, Walking recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Arm (Pilot)
Arm Type
Experimental
Arm Description
Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)
Arm Title
Phase 2 Arm (LTF)
Arm Type
Experimental
Arm Description
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
Arm Title
Phase 3 Arm (Ventilatory Loading)
Arm Type
Other
Arm Description
Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.
Intervention Type
Other
Intervention Name(s)
Intermittent Hypoxia
Other Intervention Name(s)
Breathing Treatment
Intervention Description
Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
Intervention Type
Other
Intervention Name(s)
Locomotor Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Minute Ventilation - Phase 2
Description
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.
Time Frame
Pre- versus Post-treatment
Secondary Outcome Measure Information:
Title
Ventilatory Loading - Phase 3
Description
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.
Time Frame
Pre- versus Post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole J Tester, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24224903
Citation
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.
Results Reference
derived

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

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