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Completed

NCT Number: NCT00594178

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 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Translational Neuroscience #847

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motorized bicycle exercise training

Device

Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2010
First posted
Jan 15, 2008
Registry last updated
Jan 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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