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SlipsSRFDINCT07280988

Effectiveness of Slip Resistant Footwear in Dairy Industry

A study testing Environment specific safety footwear in people with Slips and Falls Prevention, run by Aalborg University at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the dairy industry, same-level falls are a major problem and a well-known challenge. At Arla's dairy in Taulov, where this RCT study is being carried out, reports of risk observations, near incidents, and workplace accidents have increased over the past five years. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Slips, Falls Prevention, Perceived Slipperiness
What is being tested?
Environment specific safety footwear
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteDenmark
Study dates
1 Sep 2025to 10 Dec 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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Full-time employed at Arla Taulov dairy facility.
  • No major injuries affecting their daily work.
  • No plans of retiring before the end of the study period.

Who cannot join

  • Surgery in the feet and under extremity within the last three months. Pregnancy.
  • Part-time workers.
  • Neurological disorders affecting gait.
  • Can read and understand Danish

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Arla Foods AMBA

    Taulov, 7000

Other trials in Denmark

About this study

Official title: The Effect of Environment Specific Slip Resistant Footwear - A Randomized Cross-Over Study From Danish Dairy Industry

In the dairy industry, same-level falls are a major problem and a well-known challenge. At Arla's dairy in Taulov, where this RCT study is being carried out, reports of risk observations, near incidents, and workplace accidents have increased over the past five years. Accident statistics further show that same-level falls are the most common incidents, with slippery floors and surfaces being by far the main cause of both near incidents and risk observations. Because of this, it is necessary to test different types of safety footwear that, based on laboratory studies, are considered particularly suitable for the working environment in a dairy.

it is hypothesized that employees, through subjective questionnaires, will rate one shoe as less slippery than the other. At the same time, it is hypothesized that employees will also subjectively find one shoe more comfortable than the other.

Read the detailed description

Slipping, tripping, and falling (STF) are the second most common risk factor for serious occupational accidents in Denmark, accounting for 18.9% of the cases. In fact, general fall accidents in 2016 were estimated to cause annual additional costs of 3.9 billion DKK due to lost productivity, and a further 4.8 billion DKK in healthcare and long-term care expenses. Similar numbers are observed in the United States, where STF is likewise reported as the second most common cause of workplace accidents. The primary cause of STF incidents is often insufficient friction between footwear and walking surfaces. In response to this issue, ASTM International in 2021 raised the minimum threshold for certified slip-resistant footwear, making it even more challenging for manufacturers to meet test requirements. Although recent years have brought advances in the understanding of mechanisms leading to STF events-particularly slipping-there is still insufficient research translating this knowledge into practical preventive measures. Data from the Danish Working Environment Authority confirm this gap, showing that reported STF accidents increased between 2016 and 2021. Moreover, the actual number of near incidents is likely even higher, as many are never formally registered. Implementing existing prevention knowledge into effective, practical interventions remains a key challenge. Analysis of gait patterns has been suggested as a way to better understand changes in walking stability, thereby enabling quantification of near-incidents occurrences.

This RCT study will, for the first time, combine multiple measurement parameters, including reported falls, near incidents, risk situations, perceived slip resistance, and gait characteristics (e.g., step length, cadence). These outcomes will be measured through both quantitative and qualitative methods. Quantitative gait data will be collected using accelerometers, with two sensors allocated to each participants foot/shoe. This system has previously been used to quantify gait patterns. Qualitative data will be collected through self-reported records. By linking spatiotemporal gait parameters with self-reported accident and near-miss data, this study will provide new insights into the relationship between objective and subjective safety outcomes. In addition, it is crucial to identify potential barriers and challenges experienced both by employees using slip-resistant footwear and by procurement decision-makers responsible for footwear acquisition. To address this, focus group interviews and surveys will be conducted among study participants as well as procurement staff at Arla in Taulov.

A power calculation estimated the required sample size at 28 participants, based on an expected α of 0.05, β of 0.20, and an effect size of 0.25. Allowing for an anticipated dropout rate of 20%, the recruitment target is set at 34 participants (17 in each study arm). Considering the number of employees working in slippery zones, it was decided that only a cross-over design will enable to recruit a sufficient number of participants. Employees at Arla's Taulov dairy will be recruited and randomized (1:1) to either start working with one pair of safety shoes while the other half will start with the other pair of safety shoes using a computer-generated minimization sequence, ensuring balance between groups in terms of sex, age, and prior fall history.

Quantitative and qualitative data will be presented descriptively. Following a thematic analysis approach, outcomes such as comfort, gait patterns, perceived safety, fall/near-fall experiences, and economic considerations (e.g., purchase costs) will be displayed in a structured format that provides an overview of participants' experiences of the intervention as well as perceived barriers and benefits. To evaluate changes over time, quantitative outcomes will be analyzed using two-way repeated measures ANOVA. Multiple imputation will be used to handle potential missing data, and differences between groups will be further assessed using post-hoc tests.

Being tested
Environment specific safety footwear
Keywords
occupational slips, sllips trips and falls, footwear, friction, ergonomics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Environment specific safety footwearDevice

    The participants will wear two different safety shoes (SIKA Highline and AIRTOX FW44) in the test periode (20 working days). 10 working days in each safety shoes.

Study groups in NCT07280988
Study groupRoleWhat they receive
Sika shoeExperimentalNot described
Receives: Device: Environment specific safety footwear
Airtox shoeActive comparatorNot described
Receives: Device: Environment specific safety footwear

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported feel of slipperines

    Self-rated feel of slipperiness. "To what extent did you feel the need to walk carefully today?" Rated on a continuous VAS scale (not slippey to the right and slippery to the left). Less slippery towards right and most slippery towards left. Hence, towards right is better. These are obtained with daily questionaries.

    Measured: Through study completion, an average of 20 working days

Secondary outcomes (3)
  1. Spatiotemporal gait characteristics

    Step length will be obtained using accelerometers positioned on the participants' shoes. This will be measured in meters.

    Measured: Through study completion, an average of 20 working days

  2. Slipping without falling

    "Did you experience a slip today without falling?" These are obtained with daily questionaries. Yes/No

    Measured: Through study completion, an average of 20 working days

  3. Slipping and falling

    "Did you experience a slip today resulting in a fall?" These are obtained with daily questionaries. Yes/No

    Measured: Through study completion, an average of 20 working days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start1 Sep 2025
  3. Primary completion10 Dec 2025
  4. Study completion10 Dec 2025

Resources

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
Crossover
Model description
All participants will complete two test sessions: 1) 10 working days in one pair of safety shoes followed by 2) 10 working days in another pair of safety shoes. Participants are randomized to start with one pair or the other. Participants will be instructed to resume their normal working routine throughout the study period. All participants will fill out questionnaires every day for the 20 days of testing
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07280988
Sponsor's protocol ID
20235100802
Acronym
SRFDI
Status last verified
Aug 2025
First submitted
29 Aug 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Redfern MS, Cham R, Gielo-Perczak K, Gronqvist R, Hirvonen M, Lanshammar H, Marpet M, Pai CY, Powers C. Biomechanics of slips. Ergonomics. 2001 Oct 20;44(13):1138-66. doi: 10.1080/00140130110085547.

    PubMed 11794762
  • Chang WR, Gronqvist R, Leclercq S, Myung R, Makkonen L, Strandberg L, Brungraber RJ, Mattke U, Thorpe SC. The role of friction in the measurement of slipperiness, Part 1: friction mechanisms and definition of test conditions. Ergonomics. 2001 Oct 20;44(13):1217-32. doi: 10.1080/00140130110085574.

    PubMed 11794765
  • ASTM International, "Standard Specification for Performance Requirements when Evaluating Slip Resistance of Protective (Safety) Footwear using ASTM F2913 Whole Shoe Test Method.

  • L. Strandberg and H. Lanshammar, "The dynamics of slipping accidents," J. Occup. Accid., vol. 3, pp. 153-162, 1981,

  • Hanson JP, Redfern MS, Mazumdar M. Predicting slips and falls considering required and available friction. Ergonomics. 1999 Dec;42(12):1619-33. doi: 10.1080/001401399184712.

    PubMed 10643404
  • Gronqvist R, Chang WR, Courtney TK, Leamon TB, Redfern MS, Strandberg L. Measurement of slipperiness: fundamental concepts and definitions. Ergonomics. 2001 Oct 20;44(13):1102-17. doi: 10.1080/00140130110085529.

    PubMed 11794760
  • GBD 2021 Causes of Death Collaborators. Global burden of 288 causes of death and life expectancy decomposition in 204 countries and territories and 811 subnational locations, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2100-2132. doi: 10.1016/S0140-6736(24)00367-2. Epub 2024 Apr 3.

    PubMed 38582094
  • Sundhedsstyrelsen, "Sygdomsbyrden i Danmark, Ulykker, Selvskade og Selvmord 2016," Copenhagen S, 2016.

  • Beskæftigelsesministeriet, "Et nyt og forbedret arbejdsmiljø - Bilagsrapport, Bind 1," 2018.

Questions about this trial

What is this clinical trial studying?

A study testing Environment specific safety footwear in people with Slips and Falls Prevention, run by Aalborg University at 1 site in Denmark.

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 3 inclusion and 4 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 27 Oct 2026. 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 Denmark. 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?

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?

Self-reported feel of slipperines (time frame: Through study completion, an average of 20 working days). 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 NCT07280988, which also lists 9 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 27 Oct 2026.

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