跳至主要内容
临床试验/NCT06204471
NCT06204471招募中不适用

Evaluating the Acceptability of Airbag Hip Protectors in Older People

Royal College of Surgeons, Ireland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月2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
入组人数
40
试验地点
1
主要终点
Acceptability and useability of a hip protector airbag, qualitative analysis

研究概览

简要总结

Pilot study evaluating two different airbag hip protectors to see if community-dwelling older people will wear them and find them comfortable and acceptable.

详细描述

Traditional hip protectors are specialised pads designed to shield the greater trochanter on (fall) impact. They have uncertain benefits in reducing hip fracture risk and have very poor uptake due to discomfort. Recently, airbag technology has allowed radical change in design and wearability of hip protectors. Despite these airbags being commercially available, there is little evidence of their acceptability/wearability, and as with all hip protectors, virtually no research exists in community-dwelling people. A study of traditional hip protectors found that they may reduce fear of falling (FoF) in community dwellers but activity levels or quality of life were not assessed. A non-randomised study is ongoing of hip airbags on fractures in nursing homes, but none in community dwellers. Two Hip Protectors available in Europe are CE marked as personal protective equipment and approved for sale. There is a need to evaluate their acceptability and usefulness before considering larger clinical trials evaluating their efficacy in preventing hip fractures. This study will evaluate the two hip protectors and gain patient feedback in their use.

研究设计

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

入排标准

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

入选标准

  • •Age 65 years and older
  • •1 or more falls in the last year requiring medical attention
  • •Fear of Falling (single question Y/N)
  • •Able to give informed consent

排除标准

  • •Nursing home resident
  • •Immobile, or requires another person to assist with transfers and mobility
  • •Unable to apply or remove the hip airbag independently
  • •Waist circumference <70cm or >125cm (Helite device is sized by waist) and
  • •Hip circumference <84cm or >125cm (Wolk device sized by hip)

研究组 & 干预措施

Airbag1

Experimental

Airbag1 worn for two months

干预措施: Helite hip protector (Device)

Airbag1

Experimental

Airbag1 worn for two months

干预措施: Wolk hip protector (Device)

Airbag2

Experimental

Airbag2 worn for 2 months

干预措施: Helite hip protector (Device)

Airbag2

Experimental

Airbag2 worn for 2 months

干预措施: Wolk hip protector (Device)

结局指标

主要结局

Acceptability and useability of a hip protector airbag, qualitative analysis

时间窗: After 2 month period of wearing each airbag

Tolerance of, and psychosocial impact of wearing a hip protector airbag will be explored through a semi-structured in-depth interview at the end of each 2-month period of wearing the airbag. This will explore significant patterns and themes related to acceptability of each airbag through deductive interview content analysis.

次要结局

  • Acceptability and useability of a hip protector airbag, quantitative measure(After 2 months of wearing each device.)
  • Fear of falling (FoF)(After 2 months of wearing each device)

研究者

发起方
Royal College of Surgeons, Ireland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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