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Palliative Strategies in Spinal Cord Injury (SCI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00594178
First Posted: January 15, 2008
Last Update Posted: January 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Arkansas
  Purpose
Spinal cord injury (SCI) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that decrease quality of life and prevent effective rehabilitation. Previous findings from our labs found that a passive cycling exercise program, motorized bicycle exercise training (MBET), in adult spinally transected animals reduced muscle atrophy and normalized hyperreflexia. We found that MBET could prevent the onset of hyperreflexia after spinal transaction, that MBET could also be used to rescue from hyperreflexia once it had set in, and that MBET could induce savings in normalization of reflexes after MBET ceased. We also demonstrated that MBET was effective in rescuing from hyperreflexia in a chronic ASIA B SCI patient, and that short-term MBET could lead to brief savings in normalization of reflexes once MBET ceased. The proposed studies will test the ability to MBET to prevent the onset of hyperreflexia in a group of acute SCI patients trained before hyperreflexia has had a chance to set in. In addition, the proposed research will attempt to confirm the possibility that long-term MBET in chronic SCI patients will rescue from hyperreflexia once it has set in, and also produce significant savings in normalization of reflexes if carried out for long periods of time. We will also test the possibility that MBET in acute and/or chronic SCI patients could reduce or prevent muscle atrophy. The experimental design calls for assessing muscle mass using MRI scans, bone density using Dual-Energy X-ray Absortiometry (DEXA) scans, spasticity measures and electrophysiological measurements to determine low frequency habituation of the H-reflex. Assessments will be carried out before MBET, during a 25 week MBET block of time, and during a 12 week post MBET monitoring period. Changes in muscle mass, bone density, spasticity scales and H-reflex habituation will be compared across these interventions and between treated SCI victims and a group of control acute and chronic SCI victims undergoing standard of care during the same period.

Condition Intervention
Spinal Cord Injury Device: Motorized bicycle exercise training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Palliative Strategies in Spinal Cord Injury (SCI)

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data [ Time Frame: baseline and 3 months ]
    Lean muscle mass was measured with Dual-Energy X-ray Absortiometry (DEXA) scan, which uses low dose radiation to assess bone density and soft tissue density. pre and post, three month exercise protocol on a passivie motorized exercise bicycle.


Secondary Outcome Measures:
  • Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan [ Time Frame: baseline and 3 months Post-exercise ]
    Bone mineral density was measured with Dual-Energy X-ray Absortiometry (DEXA) scan pre and post, three month exercise protocol on a passive motorized exercise bicycle.


Enrollment: 17
Study Start Date: October 2003
Study Completion Date: September 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Exercise group
Device: Motorized bicycle exercise training
Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. An incomplete spinal cord injury at a level of C4 to T12.
  • 2. 18 to 70 years of age.

Exclusion Criteria:

  • 1. Joint contractures and/or spasticity that would hamper upright posture or use of MBET
  • 2. A documented blood clot in the lower extremities
  • 3. A history of lower extremity fractures (excludes randomization to the PWBT).
  • 4. Pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594178


Locations
United States, Arkansas
Center for Translational Neuroscience #847
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Thomas S. Kiser, MD Center for Translational Neuroscience, UAMS
Study Director: Edgar Garcia-Rill, PhD Center for Translational Neuroscience, UAMS
  More Information

Responsible Party: Edgar Garcia-Rill, Director, Center for Translational Neuroscience
ClinicalTrials.gov Identifier: NCT00594178     History of Changes
Other Study ID Numbers: 24179
PRN # 12903 NIH
First Submitted: January 3, 2008
First Posted: January 15, 2008
Results First Submitted: October 1, 2010
Results First Posted: January 13, 2011
Last Update Posted: January 13, 2011
Last Verified: December 2010

Keywords provided by University of Arkansas:
spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System