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临床试验/NCT06502301
NCT06502301已完成不适用

Evaluation of Balance With Computerized Posturography Device and Clinical Tests in Patients With Postmenopausal Osteoporosis

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2020年11月1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
95
试验地点
1
主要终点
Computed static posturography

研究概览

简要总结

Osteoporosis is defined as low bone mineral density caused by altered bone microstructure, ultimately predisposing patients to fragility fractures. Osteoporotic fractures lead to a significant decrease in quality of life, increasing morbidity, mortality, and disability. Vertebral fracture may cause sagittal imbalance which leading to postural instability and becomes a possible risk factor for falls. The cause of balance problems in osteoporotic patients is multifactorial including increased thoracic kyphosis and postural sway, however the exact relationship between vertebral fractures and balance remains unclear. The aim of the study is; to evaluate the effect of the presence of a vertebral fracture on balance and physical performance and its contribution to fall and fracture risk in patients with postmenopausal osteoporosis.

详细描述

Osteoporosis is a metabolic bone disease characterized by low bone mass, deterioration of bone tissue, and disruption of bone microarchitecture . It is known that the incidence of vertebral fractures in women with osteoporosis increases especially after the age of 50. In the United States, one in four women older than 50 years suffers at least one osteoporosis-related vertebral compression fractures. Approximately one-third of vertebral fractures become symptomatic . Vertebral fracture may cause increased dorsal kyphosis and, the center of gravity of the body moves forward. Impaired postural stability is associated with fall risk and functional disability .

Many authors argue that the osteoporotic vertebral fractures are associated with an increase in the thoracic curve. There are studies revealing that hyperkyphosis may be a clinically useful marker for history of vertebral fracture and also a risk factor for a new vertebral fracture. Postmenopausal women with vertebral fracture have a 4-fold increased risk of new fractures compared to whom without spinal fracture. Recent vertebral fractures have a strong impact on daily living activities and are significant predictors of poor performance in functional status of the patient. However this triangle among vertebral fractures, kyphosis and balance has not been well documented in the literature.

The vertebral fracture cascade phenomena raises the possibility that multiple factors, such as spinal characteristics, vertebral alignment, spinal curvature, and spinal loads, as well as low bone mineral density, may have an impact on falls and fractures. Vertebral fracture may cause sagittal imbalance which leading to postural instability and becomes a possible risk factor for falls. Especially in osteoporotic elderly; falls are associated with high morbidity and mortality. However the effect of a vertebral fracture, as a preventable risk factor on balance impairment has not been studied sufficiently. In this study, we aimed to assess the effect of the presence of a vertebral fracture on balance and physical performance and its additional contribution to fall and fracture risk in patients with postmenopausal osteoporosis.

研究设计

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

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 50 years or older
  • Diagnosis of postmenopausal osteoporosis according to WHO (World Health Organization) criteria and/or osteoporotic vertebral fractures

排除标准

  • A history of neurological and/or vestibular system disease
  • Using a medication that may affect balance and proprioception
  • The presence of a psychotic disorder
  • A history of lower extremity surgery in the last 6 months

结局指标

主要结局

Computed static posturography

时间窗: Baseline

Computerized systems play a crucial role in the quantitative and dynamic evaluation of balance function. The Tetrax device, a computerized static posturography system developed by Sunlight Medical Ltd, Israel, was utilized in our study. This device is valuable for both diagnosis and treatment purposes, offering quantitative assessment of balance. Participants underwent evaluation using the Tetrax device, which involved 32-second measurements in eight different positions. The device calculates several parameters including the Stability Index (SI), Fall Index (FI), and Fourier frequencies, providing objective measures of balance function.

次要结局

  • Tandem stance test(10 second)
  • Fracture Risk Assessment tool (FRAX)(Baseline)
  • Berg balance scale (BBS)(Baseline)
  • Timed and go test (TUG)(Baseline)
  • Tandem gait test(Baseline)
  • Dual-energy x-ray absorptiometry measurements(Baseline)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilara Okutan Kuzu

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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