Evaluating the Acceptability of Airbag Hip Protectors in Older People
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
Airbag1 worn for two months
干预措施: Helite hip protector (Device)
Airbag1
Airbag1 worn for two months
干预措施: Wolk hip protector (Device)
Airbag2
Airbag2 worn for 2 months
干预措施: Helite hip protector (Device)
Airbag2
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)
