Acceptability of Hip Protector Airbags in Older People

Not Applicable

Recruiting

• Conditions: Falls Risk
• Interventions: Device: Helite hip protector; Device: Wolk hip protector

• Registration Number: NCT06204471
• Lead Sponsor: Royal College of Surgeons, Ireland

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.

Study Timeline

• Study First Submitted: 2023-11-14
• Status Verified: 2024-01
• Study Start: 2024-01-02
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Airbag1	Wolk hip protector	Airbag1 worn for two months
Airbag2	Helite hip protector	Airbag2 worn for 2 months
Airbag2	Wolk hip protector	Airbag2 worn for 2 months
Airbag1	Helite hip protector	Airbag1 worn for two months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Beaumont Hospital; 🇮🇪 Dublin, Ireland