跳至主要内容
临床试验/NCT06842758
NCT06842758进行中(未招募)不适用

Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures

University of Palermo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Degree of Hyperkyphosis

研究概览

简要总结

Multiple vertebral fragility fractures, one of the main complications of osteoporosis, are frequently associated with thoracic hyperkyphosis, which in turn leads to significant postural alterations.

These biomechanical changes may increase fall risk, posing a critical clinical issue for elderly patients. However, the results of studies investigating the association between hyperkyphosis and fall risk are conflicting, highlighting the need for further research.

This study aims to explore the correlation between the severity of thoracic kyphotic curvature and fall risk in patients with multiple fragility fractures undergoing osteoporosis treatment.

Additionally, the study seeks to evaluate the role of physiotherapy in improving patients' functional and postural outcomes.

A retrospective observational study was conducted, supplemented by a narrative literature review to contextualize the findings. Forty patients undergoing treatment at the Functional Recovery and Rehabilitation Unit (UOC) of P. Giaccone University Hospital in Palermo were enrolled and followed up via biannual phone interviews. Data were collected between May 2023 and May 2024, with a longitudinal assessment of outcomes from T0 (baseline) to T1 (12 months).

The severity of the kyphotic curve was quantified using the Cobb method, while fall risk was assessed through the Berg Balance Scale. Participation in physiotherapy programs was analyzed to evaluate their impact on clinical and functional outcomes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Women aged ≥65 years.
  • Presence of at least three documented vertebral fragility fractures.
  • Diagnosis of thoracic hyperkyphosis

排除标准

  • History of orthopedic surgeries involving the spine or lower limbs.
  • Treatments for cerebrovascular diseases.
  • Presence of balance disorders.
  • Active oncological diseases.
  • Use of walking aids

结局指标

主要结局

Degree of Hyperkyphosis

时间窗: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);

Cobb's method by 2p radiographic examination of the whole spine

Number of falls in the last year

时间窗: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);

Evaluation of the number of falls in the last year

Balance

时间窗: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);

Assessment of balance by means of the Berg Scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof.ssa Giulia Letizia Mauro

Professor

University of Palermo

研究点 (1)

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