Healthy VolunteersNCT06173635
A Comparison Study of the Maxi Move 5 (MM5) Device
A study testing Maxi Move 5 in people with Healthy Volunteers, run by Arjo AB at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Maxi Move 5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Dec 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Design and Creative Art at Loughborough University
Loughborough
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- Maxi Move 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxi Move 5Device
4 comparative devices will be used to evaluate the MM5 device
| Study group | Role | What they receive |
|---|---|---|
| Maxi Move 5 | Other | 24 healthy volunteers will evaluate all 5 devices Receives: Device: Maxi Move 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start20 Dec 2023
- Primary completion28 Feb 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arjo AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Loughborough University
- Responsible party
- Sponsor
- Investigators
- Karin Hannander, Study director, Arjo AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173635
- Sponsor's protocol ID
- MaxiMove5-MACC-001-2023
- Status last verified
- Aug 2024
- First submitted
- 23 Oct 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Laboratory Trial to Explore the Benefits of the New Maxi Move 5 (MM5) Technology
- ClinicalTrials.gov ID
- NCT06173635
- Acronym / sponsor ID
- MaxiMove5-MACC-001-2023
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Arjo ABIndustry (pharma, biotech, devices)
- Collaborators
- Loughborough University
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maxi Move 5 | Other | Device: Maxi Move 524 healthy volunteers will evaluate all 5 devices |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxi Move 54 comparative devices will be used to evaluate the MM5 device | Device | Maxi Move 5 |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Hannander study director
Arjo AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxi Move 5 in people with Healthy Volunteers, run by Arjo AB at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Time to complete each transfer will be recorded (time frame: up to 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.