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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intermittent Hypoxia and Locomotor Training: Effects Following SCI

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 Summary: 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.
Sponsor: VA Office of Research and Development

Current Primary Outcome: Minute Ventilation - Phase 2 [ Time Frame: Pre- versus Post-treatment ]

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.


Original Primary Outcome: Minute ventilation [ Time Frame: At the end of the treatment intervention (after 2 weeks) ]

Current Secondary Outcome: Ventilatory Loading - Phase 3 [ Time Frame: Pre- versus Post-treatment ]

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.


Original Secondary Outcome:

  • Propulsion generated during stepping [ Time Frame: At the end of the treatment intervention (after 2 weeks) ]
  • Arm Swing [ Time Frame: At the end of the treatment intervention (after 2 weeks) ]
  • Volitional arm and leg movement (voluntary activation deficits) [ Time Frame: At the end of the treatment intervention (after 2 weeks) ]


Information By: VA Office of Research and Development

Dates:
Date Received: January 5, 2011
Date Started: May 2010
Date Completion:
Last Updated: February 26, 2016
Last Verified: February 2016