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

Spinal Cord Injuries Clinical Trial

Official title:

Intermittent Hypoxia and Locomotor Training: Effects Following SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272011
• Other study ID #: B7182-W
• Status: Completed
• Phase: N/A
• First received: January 5, 2011
• Last updated: September 22, 2014
• Start date: May 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brown Sequard
• Central Cord Syndrome
• Spinal Cord Injuries

Intervention

Other:
• Breathing (Hypoxia) Treatment
Hypoxia (breathing 1/3 less oxygen than what is present in normal room air) versus non hypoxia will be compared to determine whether respiratory drive can be increased following spinal cord injury.
• Breathing (Hypoxia) Treatment and Locomotor Training
Comparison of the effect of locomotor training with versus without a breathing (hypoxia) treatment. Individuals will be randomized to receiving hypoxia or normal room air. They will receive either the experimental or placebo comparator (whichever they were randomized to) preceding the locomotor training. All individuals, however, will receive locomotor training.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Florida, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minute ventilation		Post-treatment	No
Secondary	Propulsion generated during stepping		At the end of the treatment intervention (after 2 weeks)	No