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临床试验/NCT05156944
NCT05156944已完成不适用

Effect of Physiotherapy in Patients Presenting to the Emergency Department After a Fall. A Brief Intervention Focusing on Patient Reported Outcomes

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2022年1月6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
104
试验地点
2
主要终点
Change in short International Falls efficacy scale (sFES-I)

研究概览

简要总结

The aim of this monocentric, block-randomized, controlled, open-label, parallel-group study is to assess whether patients presenting to the emergency department (ED) with a fall within the past 7 days would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at the time of ED presentation. Primary objective of this study is to assess "fear of falling" 7 days after ED presentation with versus without a physiotherapy intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • Written informed consent
  • History of falls within the last 7 days
  • Presentation to the ED of the University Hospital Basel

排除标准

  • Inpatient disposition after ED work-up
  • Immobilizing fractures of the lower extremities
  • Inability or contraindications to undergo the investigated intervention or follow the study procedures, e.g. due to certain neurological disorders (such as parkinsonism, hemiplegia, severe multiple sclerosis), language problems, psychological disorders, cognitive impairment
  • Prior enrolment in this trial

结局指标

主要结局

Change in short International Falls efficacy scale (sFES-I)

时间窗: At Day 0 and Day 7 ± 7 days

Change in the fear of falling between groups at day 7, measured by the short International Falls efficacy scale (sFES-I). It is a 7-item questionnaire where individuals are instructed to score their concern of falling during an activity on a 4 point Likert scale with 1 as not concerned at all and 4 as very concerned. The item scores are summed up to obtain a total, with a higher score indicating a higher fear of falling.

次要结局

  • Occurence of falls(Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
  • Feasibility of the intervention(At Day 0)
  • Change in short International Falls efficacy scale (sFES-I)(At Day 0, Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
  • Utilization of medical resources(Day 7 ± 7 days, Day 21 ± 3 days, Day 42 ± 3 days)
  • Satisfaction with ED work-up(Day 7 ± 7 days)
  • Objective functional levels in the intervention group(At Day 0 and Day 7 ± 7 days)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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