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Palliative Strategies in Spinal Cord Injury (SCI)

This study is currently recruiting participants.
Verified by University of Arkansas, January 2008

Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00594178
  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 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.


Condition Intervention
Spinal Cord Injury
Device: Motorized bicycle exercise training

MedlinePlus related topics:   Exercise and Physical Fitness    Nuclear Scans    Spinal Cord Injuries   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:   Palliative Strategies in Spinal Cord Injury (SCI)

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • H-reflex modulation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   20
Study Start Date:   August 2003
Estimated Study Completion Date:   August 2008
Estimated Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Exercise group
Device: Motorized bicycle exercise training
Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594178

Contacts
Contact: Thomas S Kiser, MD     (501) 221-1311     kiserthomass@uams.edu    
Contact: Robert D Skinner, PhD     (501) 686-5183     skinnerrobertd@uams.edu    

Locations
United States, Arkansas
Center for Translational Neuroscience #847     Recruiting
      Little Rock, Arkansas, United States, 72205
      Contact: Linda Luster     501-686-5166     lusterlindad@uams.edu    
      Contact: Robert D Skinner, PhD     (501) 686-5183     skinnerrobertd@uams.edu    
      Principal Investigator: Thomas S. Kiser, MD, MPH            
      Sub-Investigator: Robert D Skinner, PhD            

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:   Director, Center for Translational Neuroscience ( Edgar Garcia-Rill )
Study ID Numbers:   24179, PRN # 12903 NIH
First Received:   January 3, 2008
Last Updated:   January 3, 2008
ClinicalTrials.gov Identifier:   NCT00594178
Health Authority:   United States: NIH;   United States: Institutional Review Board

Keywords provided by University of Arkansas:
spinal cord injury  

Study placed in the following topic categories:
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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