CClinicalTrials.gg
CompletedNCT06173635Updated Aug 14, 2024

A Comparison Study of the Maxi Move 5 (MM5) Device

An interventional study of Maxi Move 5 in Healthy Volunteers, sponsored by Arjo AB. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Arjo AB · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This trial aims to evaluate the added improvements from a caregiver and patient benefit perspective.

The trial should identify the forces involved for the caregiver when manoeuvring the lift.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Arjo AB is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

For expert patient:

  • ≥18 years
  • Healthy male or female
  • 80-100 kg

    24 healthy volunteers (caregivers) will be recruited. They will require a strong working knowledge of passive floor lifts and patient positioning with the use of loop and clip slings.

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Other
    Maxi Move 5

    24 healthy volunteers will evaluate all 5 devices

    Device: Maxi Move 5

Interventions

  • DeviceMaxi Move 5

    4 comparative devices will be used to evaluate the MM5 device

06

What researchers measure

Primary outcomes

  1. 1. Time to complete each transfer will be recorded

    Time to complete each activity and each task within the activity will be measured in seconds.

    Time frame: up to 24 months

  2. 2. A detailed hierarchical task analysis (HTA) of each activity will be completed using the video recordings and experimenter field notes for each transfer to asses the number of correct placements for each device.

    Correct placement will be visually controlled with the use of markers on the subject and the final positioning device (e.g chair, toilet or bed) for each transfer. This will be reported as distance from the ideal position.

    Time frame: up to 24 months

  3. 3. Physical load for movement of the hoist throughout the activities for each device will be measured.

    Force required to complete the range of patient and hoist positioning tasks, forward, backwards, rotation movement, patient positioning etc. These forces will be used with the HTA data to calculate the amount of physical force delivered by the participants with each device and each transfer. The forces used will be presented in newton.

    Time frame: up to 24 months

  4. 4 Collect subjective data from the caregivers that describe, comfort, ease of use, effort and willingness to adopt in practice, etc

    This will be collected by the use of questionnaires

    Time frame: up to 24 months

  5. 5 Subjective responses from the expert patient being transferred will be recorded

    This will be collected by the use of questionnaires

    Time frame: up to 24 months

07

Study locations

1 site
  • School of Design and Creative Art at Loughborough University
    Loughborough, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06173635
Lead sponsor
Arjo AB
Collaborators
Loughborough University
Responsible party
Sponsor
First posted
Dec 18, 2023
Start date
Dec 20, 2023
Primary completion
Feb 28, 2024
Completion
May 31, 2024
Last update
Aug 14, 2024

Study contacts

Karin Hannander
study director · Arjo AB

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 completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion