ClinicalTrials.gg
Status unknownNCT05551143Updated Sep 22, 2022

R2P Field Test of the EMS LiftKit: Validating Usability, Usefulness, Desirability, and Effects on Musculoskeletal Injuries in EMS Providers

An interventional study of LiftKit in Musculoskeletal Disorder, sponsored by Ohio State University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-22.

Sponsored by Ohio State University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The long-term goal of our research program is to reduce the high incidence of musculoskeletal injury associated with person-handling tasks performed by EMS providers/responders (NORA Public Safety Industry Sector). The literature shows the significant burden of these injuries, many of which affect the back and are debilitating. There is a need for effective ergonomic tools that can assist EMS providers in the patient handling tasks encountered in patient homes, particularly those patient handling situations that include restricted or tight spaces. To address this need, our prior work identified a set of potential ergonomic solutions, using a participatory process with EMS providers, for physically challenging and frequently occurring patient handling tasks that occur in patient homes. A final product of this prior work was the development of the LiftKit, which is a collection of seven tools that were shown in biomechanical validation studies with EMS providers to effectively reduce physical demands during simulated patient handling tasks in a laboratory setting. The overall objective of this proposed research-to-practice application is to evaluate the LiftKit's seven patient handling tools (interventions) in the field to assess their usability, usefulness, and desirability, as well as their impact with regards to preventing musculoskeletal injuries incurred during EMS patient handling tasks. In this field study, 30 LiftKits will be placed on EMS vehicles that service urban, suburban, and rural communities. Given the three-shift operation used by fire-service based EMS departments, there is the potential to recruit between 180 and 270 EMS providers for the study. Immediately following the training on how to use the tools and at 4, 8, and 12 months following the training, participants will be interviewed and questioned about each tools' usability, usefulness, and desirability. Frequency of each tool's use will be assessed with a questionnaire at the time of the interview and a daily Run-Use survey tool. Musculoskeletal injury data due to patient handling tasks during the 12 month follow-up period will be compared with injury data from the three-year period prior to study initiation. The final product of this work will provide the important evidence needed to widely promote the adoption of the ergonomic tools within the LiftKit, in order to reduce MSD injury risk to EMS providers associated with common patient handling tasks.

02

Conditions studied

  • Musculoskeletal Disorder

Keywords

  • EMS
  • Ergonomics
  • Musculoskeletal Disorders
  • Back Injury
  • Firefighter
03

In context

Musculoskeletal Diseases

668 studies on the registry are indexed under Musculoskeletal Diseases; 161 are open to participants now.

This study's planned enrollment of 180 is above the median of 73 across 442 interventional studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Ohio State University is the lead sponsor of 658 studies on the registry; 145 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Working EMS providers

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    LiftKit Intervention

    All participants will have access to the LiftKit that provides them with a set of tools that should reduce the physical demands experienced by EMS providers when lifting and moving patients in their homes, thereby reducing the risk of musculoskeletal disorders (MSDs).

    Other: LiftKit

Interventions

  • OtherLiftKit

    The LiftKit contains 7 tools that could assist EMS providers when lifting/moving patients. These tools are: 1. Simple Strap - A sling to lift a seated patient 2. Strap and slide stick - A strap system for raising a supine patient to a sitting posture. 3. Slip Preventer- An envelope that goes over the patients feet with high friction straps for the EMS providers to stand on that prevent the patient from sliding forward when lifted. 4. Drag Straps - straps with handles that can be clipped on tarps used to drag patients 5. The Binder Lift - a vest with handles that allow EMS providers to easily get hold of patient they need to lift. 6. Patient Turning Straps - a way to log-roll a patient that in on the floor while in a standing posture. 7. The ELK - an inflatable seat cushion that can raise a patient who in the floor to chair level

06

What researchers measure

Primary outcomes

  1. Reported Musculoskeletal Injuries

    Injuries that are due to patient handling tasks within the patient's home.

    Time frame: 12 months

Secondary outcomes

  1. Usability, Usefulness, and Desirability of the tools within the LiftKit

    Survey assessments

    Time frame: 12 months

07

Study locations

1 site
  • The Ohio State University
    Columbus, Ohio 43210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2022; primary completion for Oct 2024, 24 months later.

Of 245 non-industry interventional studies with no phase under Musculoskeletal Diseases, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 40. This study's planned 24 months is above that.

Counting every sponsor, half of 258 studies reached it within 15 months; a quarter within 5 and three quarters within 38.

Musculoskeletal Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2022
First posted
Sep 22, 2022
StartEst.
Oct 1, 2022
Primary completionEst.
Oct 31, 2024
CompletionEst.
Oct 31, 2024
Last update
Sep 22, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05551143
Responsible party
Steve Lavender (Associate Professor, Ohio State University) — Principal investigator
First posted
Sep 22, 2022
Start date
Oct 1, 2022 (estimated)
Primary completion
Oct 31, 2024 (estimated)
Completion
Oct 31, 2024 (estimated)
Last update
Sep 22, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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