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Completed

NCT Number: NCT06173635

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Design and Creative Art at Loughborough University

Loughborough, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Maxi Move 5

Device

4 comparative devices will be used to evaluate the MM5 device

Primary outcomes

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

    Time frame: up to 24 months

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

  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.

    Time frame: up to 24 months

    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.

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

    Time frame: up to 24 months

    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.

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

    Time frame: up to 24 months

    This will be collected by the use of questionnaires

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

    Time frame: up to 24 months

    This will be collected by the use of questionnaires

Sponsors and collaborators

Lead sponsor

Arjo AB

Industry

Collaborators

  • Loughborough University

Registry information

Official study title

A Laboratory Trial to Explore the Benefits of the New Maxi Move 5 (MM5) Technology

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2023
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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