Accidental FallsFLIPNCT01618786
Flooring for Injury Prevention Trial
A study testing SmartCell flooring and Plywood flooring in people with Accidental Falls and Bone Fracture, run by Dr. Stephen Robinovitch at 1 site in Canada.
Trial summary
This study will evaluate the efficacy of novel compliant flooring in reducing injuries due to falls in a long-term care facility, determine the cost effectiveness of this intervention, and assess perceptions about compliant flooring among staff, residents, and families. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Accidental Falls, Bone Fracture, Traumatic Brain Injury
- What is being tested?
- SmartCell flooring and Plywood flooring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2013to Aug 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resident rooms across four units at New Vista Society Care Home, a long-term care facility in Burnaby, BC, Canada
Who cannot join
- Resident rooms across four units at New Vista Society Care Home in which new flooring cannot be installed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Compliant Flooring to Reduce Injuries Due to Falls in Older Adults in a Long-Term Care Facility
This study will evaluate the efficacy of novel compliant flooring in reducing injuries due to falls in a long-term care facility, determine the cost effectiveness of this intervention, and assess perceptions about compliant flooring among staff, residents, and families.
The investigators hypothesize that compliant flooring will (1) reduce the incidence of injuries due to falls in long-term care residents; (2) represent an overall cost-savings when material and implementation costs are considered relative to direct and indirect costs associated with injuries due to falls; and (3) be received positively by staff, residents, and their family members.
Read the detailed description
Falls are the number one cause of unintentional injury among older adults in Canada, and are responsible for economic costs in excess of $1 billion CAD annually. In high-risk environments, such as long-term care (LTC) facilities, 60% of residents will experience at least one fall each year. Moreover, approximately 30% of falls in LTC residents result in injury, and 3 to 5% cause fractures.
A promising strategy for reducing the incidence of fall-related injuries in LTC facilities is to decrease the stiffness of the ground surface, and the subsequent force applied to the body parts at impact. Purpose-designed compliant flooring can reduce the force applied to the hip during a fall by up to 35 % (to allow a raw egg to be successfully bounced without cracking). Yet, few LTC facilities have flooring designed to reduce the impact of falls. This study will address this gap.
Resident rooms at a local LTC facility will be randomly assigned to installation of compliant flooring or control (non-compliant) flooring. Following installation, primary and secondary outcomes, including fall-related injuries and falls, will be monitored for 4 years and compared between resident rooms with and without compliant flooring. In addition, health resource utilization and their costs will be compared between resident rooms with and without compliant flooring. Perceptions about compliant flooring will be assessed among staff, residents, and their families.
- Conditions
- Accidental Falls, Bone Fracture, Traumatic Brain Injury, Head Injuries, Closed, Nursing Homes
- Being tested
- SmartCell flooring, Plywood flooring
- Keywords
- Falls, Fall injuries, Bone fracture, Hip fracture, Skull fracture, Wounds, Closed head injury, Traumatic brain injury, Concussion, Spinal cord injury, Trauma, Older adults, Long-term care, Compliant flooring, Safety floors, Balance, Injury biomechanics, Biomedical engineering, Environmental hazards, Environmental interventions
- Medical subject headings
- Fractures, Bone, Brain Injuries, Traumatic, Head Injuries, Closed, Hip Fractures, Skull Fractures, Wounds and Injuries, Brain Concussion, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartCell flooringOther
SmartCell (SATECH Inc., Chehalis, WA, USA) is a continuous rubber surface layer supported by an array of cylindrical rubber columns 14 mm in diameter, and spaced at 19 mm intervals. It has a surface hardness of 50 durometer. It has been reported to provide approximately 35% peak force attenuation during mechanical tests that simulate falls on the hip. It has also been reported to have minimal effect on balance and mobility of older women during activities of daily living. It will be covered with hospital-grade vinyl and will be inspected regularly for maintenance requirements.
Plywood flooringOther
Plywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring.
| Study group | Role | What they receive |
|---|---|---|
| Compliant Flooring (CF) | Experimental | Compliant flooring Receives: Other: SmartCell flooring |
| Control (CON) | Placebo comparator | Non-compliant flooring Receives: Other: Plywood flooring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall-related injuries
Moderate and serious injuries that result from falls in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.
Measured: 4 years
Secondary outcomes (4)
Falls
Falls in resident rooms. Assessed from incident reports at participating long-term care facility.
Measured: 4 years
Fractures
Fractures in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.
Measured: 4 years
Health resource utilization
Hospital transfers and admissions, emergency room visits, length of hospital stay, physician visits, physiotherapy and occupational therapy visits, nursing visits, diagnostic and lab procedures.
Measured: 4 years
Musculoskeletal injuries
Work-related musculoskeletal injuries experienced by staff at participating long-term care facility.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study start1 Sep 2013
- Primary completion31 Aug 2017
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Stephen Robinovitch
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Age-Well NCE Inc., Fraser Health Authority, Centre for Hip Health and Mobility, New Vista Society Care Home, Michael Smith Foundation for Health Research, Canada Research Chair Program, Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor-investigator, Dr. Stephen Robinovitch, Simon Fraser University
- Investigators
- Dawn C Mackey, PhD, Principal investigator, Simon Fraser UniversityFabio Feldman, PhD, Principal investigator, Fraser Health AuthorityAndrew C Laing, PhD, Principal investigator, University of WaterlooStephen N Robinovitch, PhD, Principal investigator, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618786
- Sponsor's protocol ID
- TIPS-001
- Other IDs
- TIR 103945
- Acronym
- FLIP
- Status last verified
- Jan 2019
- First submitted
- 11 Jun 2012
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lachance CC, Feldman F, Laing AC, Leung PM, Robinovitch SN, Mackey DC. Study protocol for the Flooring for Injury Prevention (FLIP) Study: a randomised controlled trial in long-term care. Inj Prev. 2016 Dec;22(6):453-460. doi: 10.1136/injuryprev-2016-042008. Epub 2016 Apr 4.
PubMed 27044272Mackey DC, Lachance CC, Wang PT, Feldman F, Laing AC, Leung PM, Hu XJ, Robinovitch SN. The Flooring for Injury Prevention (FLIP) Study of compliant flooring for the prevention of fall-related injuries in long-term care: A randomized trial. PLoS Med. 2019 Jun 24;16(6):e1002843. doi: 10.1371/journal.pmed.1002843. eCollection 2019 Jun.
PubMed 31233541
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Compliant Flooring to Reduce Injuries Due to Falls in Older Adults in a Long-Term Care Facility
- ClinicalTrials.gov ID
- NCT01618786
- Acronym / sponsor ID
- FLIP / TIPS-001
- Conditions
- Accidental Falls, Bone Fracture, Traumatic Brain Injury, Head Injuries, Closed, Nursing Homes
- Keywords
- Falls, Fall injuries, Bone fracture, Hip fracture, Skull fracture, Wounds, Closed head injury, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Dr. Stephen RobinovitchUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Age-Well NCE Inc., Fraser Health Authority, Centre for Hip Health and Mobility, New Vista Society Care Home, Michael Smith Foundation for Health Research, Canada Research Chair Program, Natural Sciences and Engineering Research Council, Canada
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 13 Jun 2012 (estimated)
- 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.
This study will evaluate the efficacy of novel compliant flooring in reducing injuries due to falls in a long-term care facility, determine the cost effectiveness of this intervention, and assess perceptions about compliant flooring among staff, residents, and families.
The investigators hypothesize that compliant flooring will (1) reduce the incidence of injuries due to falls in long-term care residents; (2) represent an overall cost-savings when material and implementation costs are considered relative to direct and indirect costs associated with injuries due to falls; and (3) be received positively by staff, residents, and their family members.
Detailed description
Falls are the number one cause of unintentional injury among older adults in Canada, and are responsible for economic costs in excess of $1 billion CAD annually. In high-risk environments, such as long-term care (LTC) facilities, 60% of residents will experience at least one fall each year. Moreover, approximately 30% of falls in LTC residents result in injury, and 3 to 5% cause fractures.
A promising strategy for reducing the incidence of fall-related injuries in LTC facilities is to decrease the stiffness of the ground surface, and the subsequent force applied to the body parts at impact. Purpose-designed compliant flooring can reduce the force applied to the hip during a fall by up to 35 % (to allow a raw egg to be successfully bounced without cracking). Yet, few LTC facilities have flooring designed to reduce the impact of falls. This study will address this gap.
Resident rooms at a local LTC facility will be randomly assigned to installation of compliant flooring or control (non-compliant) flooring. Following installation, primary and secondary outcomes, including fall-related injuries and falls, will be monitored for 4 years and compared between resident rooms with and without compliant flooring. In addition, health resource utilization and their costs will be compared between resident rooms with and without compliant flooring. Perceptions about compliant flooring will be assessed among staff, residents, and their families.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compliant Flooring (CF) | Experimental | Other: SmartCell flooringCompliant flooring |
| Control (CON) | Placebo comparator | Other: Plywood flooringNon-compliant flooring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident rooms across four units at New Vista Society Care Home, a long-term care facility in Burnaby, BC, Canada
Key exclusion criteria (1 listed)
- Resident rooms across four units at New Vista Society Care Home in which new flooring cannot be installed
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 |
|---|---|---|
| SmartCell flooringSmartCell (SATECH Inc., Chehalis, WA, USA) is a continuous rubber surface layer supported by an array of cylindrical rubber columns 14 mm in diameter, and spaced at 19 mm intervals. It has a surface hardness of 50 durometer. It has been reported to provide approximately 35% peak force attenuation during mechanical tests that simulate falls on the hip. It has also been reported to have minimal effect on balance and mobility of older women during activities of daily living. It will be covered with hospital-grade vinyl and will be inspected regularly for maintenance requirements. | Other | Compliant Flooring (CF) |
| Plywood flooringPlywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring. | Other | Control (CON) |
Primary outcome
Fall-related injuries
Time frame: 4 years
Moderate and serious injuries that result from falls in resident rooms. Assessed from incident and follow-up reports at participating long-term care facility.
4 secondary outcomes
Falls
Time frame: 4 years
Fractures
Time frame: 4 years
Health resource utilization
Time frame: 4 years
Musculoskeletal injuries
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Background: PubMed 27044272Lachance CC, Feldman F, Laing AC, Leung PM, Robinovitch SN, Mackey DC. Study protocol for the Flooring for Injury Prevention (FLIP) Study: a randomised controlled trial in long-term care. Inj Prev. 2016 Dec;22(6):453-460. doi: 10.1136/injuryprev-2016-042008. Epub 2016 Apr 4.
- Derived from this study: PubMed 31233541Mackey DC, Lachance CC, Wang PT, Feldman F, Laing AC, Leung PM, Hu XJ, Robinovitch SN. The Flooring for Injury Prevention (FLIP) Study of compliant flooring for the prevention of fall-related injuries in long-term care: A randomized trial. PLoS Med. 2019 Jun 24;16(6):e1002843. doi: 10.1371/journal.pmed.1002843. eCollection 2019 Jun.
- Technology for Injury Prevention in Seniors (TIPS)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Dawn C Mackey, PhD principal investigator
Simon Fraser University
Fabio Feldman, PhD principal investigator
Fraser Health Authority
Andrew C Laing, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartCell flooring and Plywood flooring in people with Accidental Falls and Bone Fracture, run by Dr. Stephen Robinovitch at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 May 2022. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall-related injuries (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01618786, which also lists 2 linked publications.
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 4 May 2022.