Falls RiskNCT06204471
Acceptability of Hip Protector Airbags in Older People
A study testing Helite hip protector and Wolk hip protector in people with Falls Risk, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Falls Risk
- What is being tested?
- Helite hip protector and Wolk hip protector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 2 Jan 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Acceptability of Airbag Hip Protectors in Older People
Pilot study evaluating two different airbag hip protectors to see if community-dwelling older people will wear them and find them comfortable and acceptable.
Read the 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.
- Conditions
- Falls Risk
- Being tested
- Helite hip protector, Wolk hip protector
- Keywords
- Hip protector, Airbag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helite hip protectorDevice
hip protector
Wolk hip protectorDevice
Hip protectdor
| Study group | Role | What they receive |
|---|---|---|
| Airbag1 | Experimental | Airbag1 worn for two months Receives: Device: Helite hip protector; Device: Wolk hip protector |
| Airbag2 | Experimental | Airbag2 worn for 2 months Receives: Device: Helite hip protector; Device: Wolk hip protector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 2 month period of wearing each airbag
Secondary outcomes (2)
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.
Measured: 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.
Measured: After 2 months of wearing each device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start2 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Pilot study of two months, then crossed over to the other for two months
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Beaumont Hospital
- Responsible party
- Sponsor
- Investigators
- Frances Dockery, MD, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204471
- Sponsor's protocol ID
- RFCTLR 73
- Status last verified
- Jan 2024
- First submitted
- 14 Nov 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: tbc
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Acceptability of Airbag Hip Protectors in Older People
- ClinicalTrials.gov ID
- NCT06204471
- Acronym / sponsor ID
- RFCTLR 73
- Conditions
- Falls Risk
- Keywords
- Hip protector, Airbag
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Beaumont Hospital
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study of two months, then crossed over to the other for two months
| Arm | Type | Receives |
|---|---|---|
| Airbag1 | Experimental | Device: Helite hip protector, Device: Wolk hip protectorAirbag1 worn for two months |
| Airbag2 | Experimental | Device: Helite hip protector, Device: Wolk hip protectorAirbag2 worn for 2 months |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helite hip protectorhip protector | Device | Airbag1, Airbag2 |
| Wolk hip protectorHip protectdor | Device | Airbag1, Airbag2 |
Primary outcome
Acceptability and useability of a hip protector airbag, qualitative analysis
Time frame: 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.
2 secondary outcomes
Acceptability and useability of a hip protector airbag, quantitative measure
Time frame: After 2 months of wearing each device.
Fear of falling (FoF)
Time frame: After 2 months of wearing each device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: Undecided. tbc
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Dockery, MD principal investigator
Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helite hip protector and Wolk hip protector in people with Falls Risk, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frances Dockery, MD (+35318093000, francesdockery@beaumont.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and useability of a hip protector airbag, qualitative analysis (time frame: After 2 month period of wearing each airbag). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.