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临床试验/NCT04087551
NCT04087551已完成不适用

Incidence of Near-falls and the Development of the Balance Recovery Falls-efficacy Scale (BRFES) for the Community-dwelling Older Adults.

Queen Margaret University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Development of the Balance Recovery Falls-Efficacy Scale (BRFES)

研究概览

简要总结

The first phase of the study aims to study the incidence of near-falls. The second phase will be to develop a scale which operationalize balance recovery confidence in the older adults. This study will determine the incidence of near-falls in a sample of community-dwelling older adults and will develop the Balance Recovery Falls-Efficacy scale (BRFES) for the community-dwelling older adults using the COSMIN method. This scale will be used to measure the confidence level of the community-dwelling older adults in their ability to execute balance recovery maneuvers in common, everyday functional activities to prevent a fall.

详细描述

This study will progress through two phases

The first phase will recruit 30 older adults from ages of 65 and older living in the community. A study administrator will contact the participants daily over a 21-day period to obtain frequency and type of event experienced e.g. no fall, fall, near fall (hand), near-fall (leg) or near-fall (other). No other details of the event will be ascertained because this preliminary study will be to determine the incidence of near-falls in a sample of community-dwelling seniors.

The second phase will be to develop a scale which operationalize balance recovery confidence in community-dwelling older adults. In the first stage of the study, twelve older adults will be recruited to develop a comprehensive list of relevant items for the scale. Purposive sampling will be used to invite participants from the earlier study. This approach will ensure sample representativeness of the population and to include participants who have had demonstrated an understanding of near-falls and balance recovery maneuvres in the previous study to develop the scale. An exhaustive list of scale items will be generated from two focus group formed by six participants using a nominal group technique. This consensus-based technique ensures that all items in the scale are relevant and comprehensible to the community-dwelling older adults to discriminate the confidence level in one's ability to perform balance recovery maneuvres. The scale will then be sent to a panel of 50 experts including healthcare professionals as well as a new group of community-dwelling older adults to determine the appropriateness of items ensuring that the scale is relevant, comprehensive and comprehensible. Delphi technique will be adopted as the method to obtain a consensus among experts to finalize the Balance Recovery Falls-Efficacy Scale (BRFES).

研究设计

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

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

  • 65-year-old and above
  • Ability to read, write and communicate in English
  • History of at least one near-fall or one fall within the last 12 months
  • Living independently in the community with or without the use of a walking aid
  • Not having any cognitive dysfunction by achieving a score of 7 or less in the 6-item cognitive impairment test (6CIT)
  • Able to walk 6 meters within 12 seconds by performing the Timed Up and Go (TUG) test
  • Able to catch a 30cm ruler by each hands using the ruler drop test

排除标准

  • Requiring any physical assistance from another person to walk within home
  • Known active malignant conditions
  • Cardiovascular conditions e.g. neurally mediated syncope, cardiac syncope, structural heart diseases e.g. aortic stenosis or hospitalization for myocardial infarction or heart surgery within 3 months
  • Pulmonary conditions e.g. serious chronic obstructive pulmonary disease or oxygen dependence
  • Musculoskeletal conditions e.g. moderate to severe osteoarthritis that could affect balance control and muscle function e.g. self-reported pain or dysfunction of the trunk and extremities, fractures or injuries in the extremities in the last 6 months
  • Neurological conditions such as Parkinson's Disease, sequelae of stroke, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS) or severe Dementia or epilepsy
  • Legal blindness, severe visual impairment, severe hearing impairment or legal deafness

结局指标

主要结局

Development of the Balance Recovery Falls-Efficacy Scale (BRFES)

时间窗: 9 months

To develop and validate the Balance Recovery Falls-Efficacy Scale (BRFES). The construct measured is the confidence in one's ability to execute balance recovery manoeuvres in common, everyday functional activities to prevent a fall. The scale response option ranged from 1 to 10 with a higher score reflecting higher confidence. The scale would have 16 items indicating a total score range of 16 to 160. A higher total score value represent a better outcome.

Incidence of near-falls

时间窗: 6 months

To determine the incidence of near-falls

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

Shawn Leng-Hsien Soh

Principal Investigator

Queen Margaret University

研究点 (2)

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