Effect of Using Low-magnitude High Frequency Mechanical Stimulation of Bone in Persons With Subacute SCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months
研究概览
简要总结
The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.
详细描述
One of the major complications in persons with spinal cord injury (SCI) is marked bone loss because it greatly predisposes to skeletal fractures, even after minimal trauma. The use of low magnitude mechanical stimulation has been shown to be both safe and effective in improving bone mass and strength in animal studies. This modality has also been shown a beneficial effect in children with disability and in postmenopausal women. The investigators are interested in obtaining data to determine the possible benefits that mechanical intervention with vibratory stimulation may have on bone in individuals with subacute SCI (e.g., >1 month after injury but <1 year). Changes in bone density and mass of the leg and arm will be determined by dual energy X-ray absorptiometry (DXA); bone architecture of the distal leg and distal arm will be determined by peripheral quantitative computed tomography; circulating metabolic markers of bone will also be performed.
OBJECTIVES
In persons with subacute spinal cord injury:
- To determine differences in bone mineral mass and parameters of bone structural integrity of the stimulated tibia versus the unstimulated tibia.
- To determine changes in the metabolic markers of bone resorption and formation in persons with subacute spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Non-ambulatory SCI, with ASIA level A or B (ASIA A or B at the time of enrollment);
- •Neurological level of injury C3-T10;
- •Duration of injury >1 month after injury but <1 year; and 6.25(OH)D levels 30ng/ml (patients with values <30ng/ml will be supplemented with vitamin D to normalize values prior to study participation).
排除标准
- •Osteoporosis or low bone mass as determined by medical history or DXA at the baseline visit;
- •Pressure ulcer that may be exacerbated by the experimental procedure;
- •Fracture of the lower extremity within the past 5 years;
- •Active heterotopic ossification (HO);
- •History of metabolic bone disease;
- •Knee replacement(s);
- •Metal hardware in the lower extremities;
- •Bisphosphonate administration;
- •Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.);
- •Renal disease (creatinine clearance < 40 mL/min);
- •25(OH)D levels <30ng/ml;
- •Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, and/or hypogonadism);
- •Alcoholism;
- •Seizure disorders;
- •History of kidney stones; and
- •Compliance 85% for every month up to the 4-month time-point
结局指标
主要结局
Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months
时间窗: The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy
Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography
次要结局
未报告次要终点
研究者
William A. Bauman, M.D.
Director
James J. Peters Veterans Affairs Medical Center