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临床试验/NCT07140835
NCT07140835尚未招募不适用

A Prospective Crossover Study Evaluating the Pedal-Controlled Surgistep Platform to Improve Ergonomics in Neurosurgical Operations

Stanford University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
试验地点
1
主要终点
Rapid Entire Body Assessment (REBA) Scale Score

研究概览

简要总结

Primary Aim: Assess improvement in ergonomics and musculoskeletal discomfort with the Surgistep compared to a standard footstool.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
None

入排标准

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

入选标准

  • •Regularly perform neurosurgical procedures (cranial/spine)
  • •Willing to use both devices (multiple times each).

排除标准

  • •Severe MSK conditions preventing device usage
  • •Inability/refusal to participate in observation or surveys.

研究组 & 干预措施

SurgiStep Platform

Experimental

The surgeon will be performing the surgery by standing over the SurgiStep Platform. The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons will be using this platform for 2 weeks, after which they will be operating on standard foot stool for 2 weeks.

干预措施: SurgiStep Platform (Device)

SurgiStep Platform

Experimental

The surgeon will be performing the surgery by standing over the SurgiStep Platform. The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons will be using this platform for 2 weeks, after which they will be operating on standard foot stool for 2 weeks.

干预措施: Standard Foot stool (Device)

Standard surgical practice

Placebo Comparator

The surgeon will be performing the surgery by standing over the standard of care (foot stool). The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons use standard foot stool for 2 weeks, and switch to SurgiStep platform for 2 weeks.

干预措施: SurgiStep Platform (Device)

Standard surgical practice

Placebo Comparator

The surgeon will be performing the surgery by standing over the standard of care (foot stool). The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons use standard foot stool for 2 weeks, and switch to SurgiStep platform for 2 weeks.

干预措施: Standard Foot stool (Device)

结局指标

主要结局

Rapid Entire Body Assessment (REBA) Scale Score

时间窗: During the surgery upto 60 minutes

The REBA (Rapid Entire Body Assessment) score, used to assess the risk of musculoskeletal disorders (MSDs) in work tasks, ranges from 1 to 15. A lower REBA score indicates a lower risk, with scores below 4 considered to have minimal risk. Higher scores indicate increased risk, with scores of 8 or more indicating a high risk that requires immediate attention and intervention

Rapid Upper Limb Assessment (RULA) Scale Score

时间窗: During the surgery upto 60 minutes

The RULA (Rapid Upper Limb Assessment) scale ranges from 1 to 7, with lower scores indicating lower risk and higher scores indicating higher risk of musculoskeletal disorders.

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

Atman Desai

Clinical Professor

Stanford University

研究点 (1)

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