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

NCT01272011 | Completed Results

• 1 other identifier: B7182-W
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries; Brown Sequard; Central Cord Syndrome

Keywords

Respiration; Spinal cord injuries; Walking recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre- versus Post-treatment

Secondary Outcomes (1)

• Ventilatory Loading - Phase 3

  Pre- versus Post-treatment

Study Arms (3)

Phase 1 Arm (Pilot)

EXPERIMENTAL

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; Other: Locomotor Training

Phase 2 Arm (LTF)

EXPERIMENTAL

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

Phase 3 Arm (Ventilatory Loading)

OTHER

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

Other: Intermittent Hypoxia

Interventions

Intermittent Hypoxia OTHER

Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.

Also known as: Breathing Treatment

Phase 1 Arm (Pilot); Phase 2 Arm (LTF); Phase 3 Arm (Ventilatory Loading)

Locomotor Training OTHER

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.

Phase 1 Arm (Pilot)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Florida: collaborator
• Wayne State University: collaborator

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• 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.

  PMID: 24224903 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Central Cord Syndrome; Respiratory Aspiration

Interventions

Respiratory Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Nicole Tester
• Organization: Malcom Randall VAMC

ntester@phhp.ufl.edu

352-376-1611

Study Officials

• Nicole J Tester, PhD

  North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 7, 2011
• Study Start: May 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 29, 2016
• Results First Posted: March 29, 2016

Record last verified: 2016-02

Locations

US (1)