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临床试验/NCT07333157
NCT07333157已完成不适用

Effects of Wearable Passive Back Support Suit on Back Pain in Caregivers

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月21日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in the Korean Oswestry Low Back Pain Disability Questionnaire(K-ODI) score

研究概览

简要总结

The physical demands of patient transport, including lifting and transferring patients, are significant contributors to the high risk of musculoskeletal disorders. Previous studies have demonstrated that these workers frequently experience musculoskeletal pain. Although current prevention strategies primarily consist of passive education on posture, there is a clear need for more active, assistive methods. The emergence of wearable passive back support suits as a potential solution is noteworthy; however, robust clinical research on the effectiveness of these devices in real-world care giving environments is currently lacking.

The objective of this study is to investigate the effects of a wearable passive back support suit on reducing and preventing the incidence of back pain in patient transporters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male adults aged 19 years or older
  • Patient transport staff at Samsung Medical Center
  • Able to wear a wearable passive back support suit
  • Height: 156cm-188cm
  • Chest circumference: 80cm-120cm
  • Thigh circumference: 36cm-62cm

排除标准

  • Severe musculoskeletal disorders of the spine
  • Severe musculoskeletal disorders of the lower extremities
  • Contractures limiting the range of motion of the spine and lower extremities
  • Fractures, open wounds, or unhealed ulcers on the spine or lower extremities
  • Difficulty using a lumbar support device due to severe medical conditions, such as cardiovascular or pulmonary diseases
  • History of osteoporotic fractures
  • Neurological disorders affecting gait (e.g., stroke, Parkinson's disease, multiple sclerosis, etc.)
  • Any other cases where the investigator determines that participation in this study is inappropriate

研究组 & 干预措施

wearable passive back support suit

Experimental

干预措施: wearable passive back support suit (Device)

traditional lumbosacral orthosis

Active Comparator

干预措施: traditional lumbosacral orthosis (Device)

结局指标

主要结局

Change in the Korean Oswestry Low Back Pain Disability Questionnaire(K-ODI) score

时间窗: baseline, Week 2(after period 1), week 4(after washout) and week 6 (after period 2)

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

Won Hyuk Chang

professor

Samsung Medical Center

研究点 (1)

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