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临床试验/NCT05207748
NCT05207748已完成不适用

The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls 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: 2022年1月27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
Bone mineral density

研究概览

简要总结

The aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute and chronic phases.

详细描述

Improving balance function is considered as an important method for reducing the risk of falling after stroke and protecting bone health. Bone mineral density, a measure of bone health, has been reported to decrease after stroke, consistent with increased bone resorption and decreased bone formation. The aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic 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
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 50 and ≤ 75 years old
  • Patients with a 10-year risk of hip fracture ≥3%, major osteoporotic fracture risk ≥20% according to the Fracture Risk Assessment Tool, FRAX, scoring
  • Patients with unilateral hemiplegia as a result of first-time stroke (onset time > 3 months)
  • Patients who can stand for at least 2 minutes independently/under supervision for measurements while standing, and who can walk at least 10 meters independently/under supervision with or without walking aid for measurements taken while walking
  • Patients whose cognitive status is able 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

  • Patients with serious cardiovascular or musculoskeletal problems that prevent walking
  • Patients with severe vision, hearing and language problems
  • Patients with other neurological (Parkinson's, epilepsy, meningitis, cerebellar disease, vertigo, dizziness, polyneuropathy, etc.) or musculoskeletal (severe low back pain, knee problems) diseases that may affect balance performance other than stroke.
  • Patients with peripheral vascular disease

结局指标

主要结局

Bone mineral density

时间窗: baseline

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

次要结局

  • Berg Balance Scale(baseline)
  • Timed up and go test(baseline)
  • Falls Self-Efficacy Scale(baseline)
  • Functional Ambulation Classification(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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