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Palliative Strategies in Spinal Cord Injury (SCI)
This study is ongoing, but not recruiting participants.
Study NCT00594178   Information provided by University of Arkansas
First Received: January 3, 2008   Last Updated: September 12, 2008   History of Changes

January 3, 2008
September 12, 2008
October 2003
July 2008   (final data collection date for primary outcome measure)
H-reflex modulation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00594178 on ClinicalTrials.gov Archive Site
  • Bone density via DEXA scan [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Muscle mass via MRI data [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
 
Palliative Strategies in Spinal Cord Injury (SCI)
Palliative Strategies in Spinal Cord Injury (SCI)

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 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 BMET 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.

 
 
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Spinal Cord Injury
Device: Motorized bicycle exercise training
Experimental: Exercise group
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
20
October 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00594178
Edgar Garcia-Rill, Director, Center for Translational Neuroscience
24179, PRN # 12903 NIH
University of Arkansas
 
Principal Investigator: Thomas S. Kiser, MD Center for Translational Neuroscience, UAMS
Study Director: Edgar Garcia-Rill, PhD Center for Translational Neuroscience, UAMS
University of Arkansas
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP