Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Spasticity Assessments
研究概览
简要总结
This study will enroll people with SCI who have spasticity and some ability to walk. The goal is to understand if standing on a platform and receiving WBV results in decreased spasticity and improved walking ability. Published article is available (PMID: 29959653)
详细描述
Phase 1 of this study has been successfully completed. The results of Phase 1 indicate that a single session of WBV lasting for a total of 6 minutes (delivered in eight 45-sec bouts) at a high-frequency (50Hz) was associated with the largest decrease in spasticity (as measured by the pendulum test). The goal for Phase 2 is to determine whether longer doses of WBV result in greater reductions in spasticity as well as improvements in walking ability. Two different doses of WBV, a short dose and a long dose, will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Masked allocation and intervention
入排标准
- 年龄范围
- 16 Years 至 72 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have spinal cord injury of at least 6 months duration; be between the ages of 16 - 72 years old; be able to sit at the edge of the mat without the assistance of another person; be able to tolerate standing; have at least mild spasticity affecting the lower extremity muscles; be able to understand and provide own consent; you may participate if you use prescription medications, including baclofen pump for control of spasticity, as the dosage is stable; obtain medical clearance for standing if you have been injured more than 1 year and are not regularly walking or standing.
排除标准
- •progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord; neurologic level below spinal level T12; history of cardiovascular irregularities; problems following instructions; orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
研究组 & 干预措施
Short duration
Short Duration WBV consists of 8 45-sec bouts of 50Hz WBV followed by a 1-minute seated rest
干预措施: Short Duration (Procedure)
Long duration
Long Duration WBV consists of 16 bouts 45-sec of 50Hz WBV followed by a 1-minute seated rest
干预措施: Long Duration (Procedure)
结局指标
主要结局
Spasticity Assessments
时间窗: Estimated 1 hour
Pendulum test, Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Questionnaire, Electrophysiological testing (Soleus H-reflex)
次要结局
- Ankle Clonus Test/Foot(Estimated 15 minutes)
- Strength(Estimated 20 minutes)
- Upper Extremity Tests(Estimated 5 minutes)
- Walking ability(Estimated 30 minutes)
- Pain perception(Estimated 20 minutes)