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临床试验/NCT07059468
NCT07059468已完成不适用

Relationship Between Bilateral Femoral Neck Bone Mineral Density and Clinical Parameters in Stroke Patients

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Dual X-ray absorptiometry (DXA)

研究概览

简要总结

The aim of this study was to investigate the clinical features affecting bone mineral density in plegic and non-plegic extremities in hemiplegic patients with stroke in the subacute and chronic phases.

详细描述

One of the common complications after stroke is secondary osteoporosis that develops due to stroke. The most important event that draws attention to bone health in stroke patients is fractures, the most serious of which in terms of morbidity and mortality are hip fractures. The risk of hip fracture in stroke patients is 2-4 times higher than the normal population due to the decrease in bone mineral density on the plegic side and the increased risk of falling. There is a loss of bone mineral density after stroke. This loss is faster and larger in the early stages of stroke and is greater on the plegic side. The factors affecting this loss of bone mineral density after stroke have not been well defined. The relationship between stroke-related bone mineral density loss and motor function, functional mobility, balance, and muscle mass is not clear. It is important to reveal the changes in bone structure after stroke and the factors affecting this change. The aim of this study was to investigate the clinical features affecting bone mineral density in plegic and non-plegic extremities in hemiplegic patients with stroke in the subacute and chronic phases.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 40-65 years with a unilateral stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT)
  • Patients with a cognitive status sufficient to understand the study instructions (Mini-Mental State Assessment score ≥ 23)
  • Patients with stable medical and psychological status
  • Patients willing to participate in the study

排除标准

  • Presence of hip pathologies that may lead to incorrect measurements in bone mineral density (advanced osteophytic coxarthrosis, heterotrophic ossification, internal fixator, etc.)
  • Previous hip, lumbar vertebra fractures (osteoporotic compression fractures)
  • History of multiple strokes
  • History of concomitant neurological diseases other than stroke (Parkinson, multiple sclerosis, myopathy, etc.)
  • History of diseases that may cause secondary osteoporosis (hypogonadism, primary hyperparathyroidism, thyrotoxicosis, malabsorption, etc.)

结局指标

主要结局

Dual X-ray absorptiometry (DXA)

时间窗: baseline

Bone mineral density/ Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method./ Baseline

次要结局

  • Ultrasonographic evaluation(baseline)
  • Manual muscle strength measurement/ Muscle strength(baseline)
  • Fugl-Meyer Lower Extremity Motor Subscale(baseline)
  • Functional Ambulation Classification(baseline)
  • Spasticity assessment/ Ashworth graded spasticity from 0 to 4(baseline)
  • Berg Balance Scale(baseline)
  • International Fall Activity Scale(baseline)

研究者

发起方
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuğba Atan, MD

Assoc. Prof

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

研究点 (1)

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