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临床试验/NCT05318508
NCT05318508已完成不适用

Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年4月10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
30
试验地点
1
主要终点
Thoracic kyphosis

研究概览

简要总结

The aim of this study is to investigate the relationship between sagittal spinopelvic parameters and low back pain and quality of life in individuals with lower extremity amputation.

详细描述

Low back pain is one of the secondary health problems that negatively affect functionality, independence and quality of life in individuals with lower extremity amputation. The prevalence of low back pain was reported to be higher in individuals with lower extremity amputation (52-89%) than in the non-amputee population (12-45%). Although the etiology of low back pain is multifactorial, changing anatomy and biomechanics after lower extremity amputation and maintaining daily activities are often associated with the development of low back pain. Postural imbalance, which is one of the musculoskeletal disorders of the spine that contributes to low back pain, is considered to cause additional load on the spinal structures.

研究设计

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

入排标准

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

入选标准

  • Patients aged ≥ 18 and ≤ 65 years
  • Patients followed for at least 12 months with lower extremity amputation
  • Patients who have been using prosthesis for at least 3 months
  • Patients with stable medical and psychological status
  • Patients willing to participate in the study

排除标准

  • Patients with serious cardiovascular, pulmonary, neurological disease or other musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery) that impair walking
  • Patients with severe vision, hearing and language problems

结局指标

主要结局

Thoracic kyphosis

时间窗: baseline

The angle between the line drawn perpendicular to the line through the T4 upper end plate and the lines drawn perpendicular to the line through the T12 lower end plate.

次要结局

  • Lumbar lordosis(baseline)
  • Cervical lordosis(baseline)
  • Pelvic tilt(baseline)
  • Pelvic incidence(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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