Skip to main content
Clinical Trials/NCT06173635
NCT06173635
Completed
N/A

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

Arjo AB1 site in 1 country21 target enrollmentDecember 20, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy Volunteers
Sponsor
Arjo AB
Enrollment
21
Locations
1
Primary Endpoint
1. Time to complete each transfer will be recorded
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 20, 2023
End Date
May 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Arjo AB
Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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.

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

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. 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 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

Study Sites (1)

Loading locations...

Similar Trials