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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: Maxi Move 5

• Registration Number: NCT06173635
• Lead Sponsor: Arjo AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-18
• Study Start: 2023-12-20
• Primary Completion: 2024-02-28
• Study Completion: 2024-05-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maxi Move 5	Maxi Move 5	24 healthy volunteers will evaluate all 5 devices

Primary Outcome Measures

Name	Time	Method
1. Time to complete each transfer will be recorded	up to 24 months	Time to complete each activity and each task within the activity will be measured in seconds.
5 Subjective responses from the expert patient being transferred will be recorded	up to 24 months	This will be collected by the use of questionnaires
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.	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. Physical load for movement of the hoist throughout the activities for each device will be measured.	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 Collect subjective data from the caregivers that describe, comfort, ease of use, effort and willingness to adopt in practice, etc	up to 24 months	This will be collected by the use of questionnaires

Trial Locations

Locations (1)

School of Design and Creative Art at Loughborough University; 🇬🇧 Loughborough, United Kingdom