An interventional study of Helite hip protector and Wolk hip protector in Falls Risk, sponsored by Royal College of Surgeons, Ireland. Recruiting at 1 site in Ireland. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Royal College of Surgeons, Ireland · Not applicable, Interventional, and Other
Pilot study evaluating two different airbag hip protectors to see if community-dwelling older people will wear them and find them comfortable and acceptable.
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.
Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Airbag1 worn for two months
Device: Helite hip protector · Device: Wolk hip protector
Airbag2 worn for 2 months
Device: Helite hip protector · Device: Wolk hip protector
hip protector
Hip protectdor
Acceptability and useability of a hip protector airbag, qualitative analysis
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.
Time frame: After 2 month period of wearing each airbag
Acceptability and useability of a hip protector airbag, quantitative measure
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.
Time frame: After 2 months of wearing each device.
Fear of falling (FoF)
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.
Time frame: After 2 months of wearing each device
Plan to share: Undecided — tbc
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Royal College of Surgeons, Ireland