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临床试验/NCT00594178
NCT00594178已完成不适用

Palliative Strategies in Spinal Cord Injury (SCI)

University of Arkansas2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2003年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Joint contractures and/or spasticity that would hamper upright posture or use of MBET
  • A documented blood clot in the lower extremities
  • A history of lower extremity fractures (excludes randomization to the PWBT).
  • Pregnant women

结局指标

主要结局

Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data

时间窗: 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.

次要结局

  • Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan(baseline and 3 months Post-exercise)

研究者

申办方类型
Other

研究点 (2)

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