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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06173635
• Other study ID #: MaxiMove5-MACC-001-2023
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: Arjo AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: May 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Maxi Move 5
4 comparative devices will be used to evaluate the MM5 device

Locations

Country	Name	City	State
United Kingdom	School of Design and Creative Art at Loughborough University	Loughborough

Sponsors (2)

Lead Sponsor	Collaborator
Arjo AB	Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 24 months
Primary	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.	up to 24 months
Primary	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.	up to 24 months
Primary	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	up to 24 months
Primary	5 Subjective responses from the expert patient being transferred will be recorded	This will be collected by the use of questionnaires	up to 24 months