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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Maxi Move 5

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Maxi Move 5; 24 healthy volunteers will evaluate all 5 devices	Device: Maxi Move 5; 4 comparative devices will be used to evaluate the MM5 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Arjo AB
• Collaborators: Loughborough University
• Investigators: Study Director: Karin Hannander, Arjo AB

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MaxiMove5-MACC-001-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No