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

NCT06173635 | Completed

• 1 other identifier: MaxiMove5-MACC-001-2023
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Maxi Move 5

OTHER

24 healthy volunteers will evaluate all 5 devices

Device: Maxi Move 5

Interventions

Maxi Move 5 DEVICE

4 comparative devices will be used to evaluate the MM5 device

Maxi Move 5

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For expert patient:
• ≥18 years
• Healthy male or female
• 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.

Sponsors & Collaborators

• Arjo AB: lead
• Loughborough University: collaborator

Study Sites (1)

School of Design and Creative Art at Loughborough University

Loughborough, United Kingdom

Location

Study Officials

• Karin Hannander

  Arjo AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: December 18, 2023
• Study Start: December 20, 2023
• Primary Completion: February 28, 2024
• Study Completion: May 31, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

GB (1)