NCT07280988

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 29, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

occupational slipssllips trips and fallsfootwearfrictionergonomics

Outcome Measures

Primary Outcomes (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.

    Through study completion, an average of 20 working days

Secondary Outcomes (3)

  • Spatiotemporal gait characteristics

    Through study completion, an average of 20 working days

  • Slipping without falling

    Through study completion, an average of 20 working days

  • Slipping and falling

    Through study completion, an average of 20 working days

Other Outcomes (5)

  • Working hours

    through study completion, an average of 20 working days

  • Division of work

    Through study completion, an average of 20 working days.

  • Floor type

    Through study completion, an average of 20 working days.

  • +2 more other outcomes

Study Arms (2)

Sika shoe

EXPERIMENTAL
Device: Environment specific safety footwear

Airtox shoe

ACTIVE COMPARATOR
Device: Environment specific safety footwear

Interventions

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.

Airtox shoeSika shoe

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arla Foods AMBA

Taulov, 7000, Denmark

Location

Related Publications (9)

  • 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.

    PMID: 11794762BACKGROUND
  • 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.

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

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

    BACKGROUND
  • 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.

    PMID: 10643404BACKGROUND
  • 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.

    PMID: 11794760BACKGROUND
  • 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.

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

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

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not made aware of which shoe pair range the best in the laboratory studies. However, no masking of the shoes visual appearance are made.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2025

First Posted

December 15, 2025

Study Start

September 1, 2025

Primary Completion

December 10, 2025

Study Completion

December 10, 2025

Last Updated

December 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations