Falls Risk
Conditions
Keywords
Hip protector, Airbag
Brief summary
Pilot study evaluating two different airbag hip protectors to see if community-dwelling older people will wear them and find them comfortable and acceptable.
Detailed 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.
Interventions
DEVICEHelite hip protector
hip protector
DEVICEWolk hip protector
Hip protectdor
Sponsors
Beaumont Hospital
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot study of two months, then crossed over to the other for two months
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and useability of a hip protector airbag, qualitative analysis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and useability of a hip protector airbag, quantitative measure | After 2 months of wearing each device. | SUS (System Usability Scale): The SUS is adapted for the purposes of this study, from similar in the literature and consists of 10 questions each uses a 10 point Likert scale rating factors such as ease of use, charging the device, appearances etc. A high score (100 max score) means highly rated, and 10 (lowest score) means poorly rated. |
| Fear of falling (FoF) | After 2 months of wearing each device | FoF will be assessed using the FES1 (Falls Efficacy Scale International 1) questionnaire. This uses a 4 point scale for subjective level of concern for 16 questions related to falls and activity. Maximum scores is 64 for highest level of concern or fear of falling. |
Countries
Ireland
Contacts
Primary ContactFrances Dockery, MD
Outcome results
None listed