Acceptability of Hip Protector Airbags in Older People

Royal College of Surgeons, Ireland

Status: Enrolling

Conditions: Falls Risk

Treatments: Device: Wolk hip protector; Device: Helite hip protector

Study type: Interventional

Funder types: Other

Identifiers

NCT06204471

RFCTLR 73

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Airbag1

Experimental group

Description:

Airbag1 worn for two months

Treatment:

Device: Helite hip protector

Device: Wolk hip protector

Airbag2

Experimental group

Description:

Airbag2 worn for 2 months

Treatment:

Device: Helite hip protector

Device: Wolk hip protector