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

NCT ID: NCT01272011

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2014-08-31

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.

Conditions

Spinal Cord Injuries; Brown Sequard; Central Cord Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Intermittent Hypoxia

Intervention Type: OTHER

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

Locomotor Training

Intervention Type: 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 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

Group Type: EXPERIMENTAL

Intermittent Hypoxia

Intervention Type: OTHER

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

Phase 3 Arm (Ventilatory Loading)

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

Group Type: OTHER

Intermittent Hypoxia

Intervention Type: OTHER

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

Interventions

Intermittent Hypoxia

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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Breathing Treatment

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole J Tester, PhD

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System

Locations

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24224903 (View on PubMed)

Other Identifiers

B7182-W

Identifier Type: -

Identifier Source: org_study_id