跳至主要内容
临床试验/NCT05611775
NCT05611775招募中不适用

Real-World Functional Activity in Adult Spinal Deformity Surgery

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
50
试验地点
1
主要终点
Motion Analysis Lab - Change in function

研究概览

简要总结

The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •Diagnosis of degenerative thoracolumbar deformity
  • •Deformity correction surgery scheduled with either Dr. Elder or Dr. Fogelson, minimum 4-level fusion with fixation to the pelvis.

排除标准

  • •° Unable to return to Mayo Clinic for follow-up evaluation

研究组 & 干预措施

Activity Monitor Assessment

Other

Subjects will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester and have activity monitored in the free-living environment.

干预措施: Triaxial accelerometer (Device)

结局指标

主要结局

Motion Analysis Lab - Change in function

时间窗: Baseline, 6-12 weeks post-surgery, 1 year

Spatiotemporal measures including velocity, step/stride length, step width, single/double support times, and R/L temporal symmetriesm will be used to measure function.

Motion Analysis Lab - Change in gait

时间窗: Baseline, 6-12 weeks post-surgery, 1 year

Gait will be measured by segmental and joint range of motion, peak kinetics during walking, and changes in deviation from normal bands using sensory processing measures.

Motion Analysis Lab - Change in trunk stability

时间窗: Baseline, 6-12 weeks post-surgery, 1 year

Trunk stability will be measured by EMG frequency content and activation pattern during gait and postural sway.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin D. Elder

Principal Investigator

Mayo Clinic

研究点 (1)

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