Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001209280
Ethics application status
Approved
Date submitted
13/07/2018
Date registered
19/07/2018
Date last updated
19/07/2019
Date data sharing statement initially provided
17/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing of a patient lifting and transfer device
Scientific title
Testing of a class 1 medical device for lifting and transferring patients, to inform user-centric product development towards commercialisation
Secondary ID [1] 295554 0
None
Universal Trial Number (UTN)
U1111-1217-4510
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reduced Mobility 308817 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307749 307749 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study seeks feedback on different models of a mechanical mobility device that enables a carer to transfer a person from seat to seat. Condition, physique, age, cultural and personal preferences may influence the usability of the device for individuals. No health outcomes are to be influenced or measured in relation to the use of the device.

Researchers from the company developing the device will carry out short tests with participants taking approximately 30 minutes. Participants will use the device, either as a carer lifting a person or as a person with reduced mobility being lifted. Researchers will fill out a questionnaire with participants concerning satisfaction with the device and suggested improvements. Participants will be able to choose if they would like to participate in follow-up tests with other variations of the device, or else a longer trial.

In a longer trial, participants (patients and carers) would be loaned a device to use at the residence of the patient for a period of time to be agreed between the researchers and the participants, e.g. one week. Carers would be trained how to use the lifter at the beginning of the trial. Researchers would ask that the device be used alternative to the current equipment in situations where it was a practical alternative, for the duration of the trial. Participants would provide feedback at the end of the trial, based on a questionnaire. The questionnaire would query participant satisfaction with the lifter, how many times they used the lifter, why they might have chosen to use other devices during the trial, when the lifter worked well and when it didn't.
Intervention code [1] 301850 0
Treatment: Devices
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306738 0
A study-specific questionnaire will be used to evaluate satisfaction with the device.
Timepoint [1] 306738 0
After first use in a short test and, if applicable, immediately following a longer trial (e.g. 1 week) involving multiple uses..
Secondary outcome [1] 349396 0
A study-specific questionnaire will be used to query suggested improvements.
Timepoint [1] 349396 0
After first use in a short test and, if applicable, immediately following a longer trial (e.g. 1 week) involving multiple uses..

Eligibility
Key inclusion criteria
Either a person with reduced mobility who normally requires some assistance to move from seat to seat, or a person in a caring profession for people of reduced mobility.
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For people with reduced mobility, exclusions are made based on :
- Height greater than 190cm or weight greater than 120kg
- Unstable medical conditions, e.g. unstable heart condition
- Conditions requiring ventilation or oxygen therapy
- Conditions not allowing uprightness
- Open wounds or painful scars on the chest
- Conditions significantly decreasing sensory feedback from the skin, e.g. neuropathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/07/2018
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
250
Accrual to date
48
Final
Recruitment outside Australia
Country [1] 10644 0
New Zealand
State/province [1] 10644 0
Canterbury

Funding & Sponsors
Funding source category [1] 300130 0
Commercial sector/Industry
Name [1] 300130 0
HT Systems Ltd.
Country [1] 300130 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
HT Systems Ltd.
Address
Centre for Entrepreneurship, Level 6 Rehua, Forestry Rd, Ilam, Christchurch, 8041
Country
New Zealand
Secondary sponsor category [1] 299531 0
None
Name [1] 299531 0
Address [1] 299531 0
Country [1] 299531 0
Other collaborator category [1] 280237 0
University
Name [1] 280237 0
University of Canterbury
Address [1] 280237 0
20 Kirkwood Ave,
Christchurch,
8041
Country [1] 280237 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300968 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 300968 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 300968 0
New Zealand
Date submitted for ethics approval [1] 300968 0
21/05/2018
Approval date [1] 300968 0
12/07/2018
Ethics approval number [1] 300968 0
18/NTB/100

Summary
Brief summary
The study is being carried out to test the usability of multiple and successive prototypes of a patient lifter for care of individuals with reduced mobility. The feedback provided by participants will be used to inform product development of the device. The general concept of the lifter has been innovated as a simple, light and efficient alternative to common lifting aids such as hoists, with particular focus on being inexpensive and carer-friendly. Up to 250 participants would be recruited between July 2018 and August 2019 to test devices and provide feedback.

Participants would include those being lifted as well as carers. The majority of participants would be recruited from staff and residents in participating residential aged-care organisations. However, younger participants with disability resulting from causes such as spine injury, stroke and cerebral palsy would also be sought for recruitment, along with their carers. Feedback from test participants will be used to inform product development towards the commercialisation of the lifter. Robust feedback from a wide range of potential users will promote an optimised, user-centric solution.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85454 0
Mr Mike MacLeod
Address 85454 0
Centre for Entrepreneurship, Level 1,
Forestry Building, Forestry Rd,
Ilam,
Christchurch, 8041
Country 85454 0
New Zealand
Phone 85454 0
+64 275002006
Fax 85454 0
Email 85454 0
[email protected]
Contact person for public queries
Name 85455 0
Mr Mike MacLeod
Address 85455 0
Centre for Entrepreneurship, Level 1,
Forestry Building, Forestry Rd,
Ilam,
Christchurch, 8041
Country 85455 0
New Zealand
Phone 85455 0
+64 275002006
Fax 85455 0
Email 85455 0
[email protected]
Contact person for scientific queries
Name 85456 0
Mr Mike MacLeod
Address 85456 0
Centre for Entrepreneurship, Level 1,
Forestry Building, Forestry Rd,
Ilam,
Christchurch, 8041
Country 85456 0
New Zealand
Phone 85456 0
+64 275002006
Fax 85456 0
Email 85456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.