Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000790842
Ethics application status
Approved
Date submitted
1/04/2021
Date registered
23/06/2021
Date last updated
4/10/2022
Date data sharing statement initially provided
23/06/2021
Date results information initially provided
7/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The acceptability and accessibility of magnetic walking aids when used in hospital: a randomised trial
Scientific title
A hospital-based parallel randomized trial assessing the acceptability and accessibility of Magnetics walking aids (MWAs) compared to standard walking aids (SOCs) in patients following joint replacement.
Secondary ID [1] 303802 0
Nil
Universal Trial Number (UTN)
Trial acronym
MWAT - Magnetic Walking Aid Trial
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
In Hospital Falls 321308 0
Joint replacement surgery 321868 0
Condition category
Condition code
Injuries and Accidents 319097 319097 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 319594 319594 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Title: Magnetic walking aid attachments (MWA) for walking sticks and elbow crutches.
WHY: Patients require walking aids post joint replacement. Failure to use these aids, or difficulty accessing the aid, Can lead to adverse outcomes such as inappropriate weight-bearing, loss of balance and falls. This study will investigate whether a MWA's enables simpler, safer and more secure access to a mobility assistive device and increases walking aid acceptability within the hospital after joint replacement compared to standard walking aids, i.e., the normal standard of care (SOC). Standard of care (SOC) in the context of the this trial includes participants using non magnetics walking aids. All participants will receive hospital level standard of care including medications, hospital facilities and multidisciplinary care.
WHAT: Magnetic rubber-coated discs with a velcro strap to allow the magnet to be fastened to walking sticks and elbow crutches. Thin metal plates (iron) 10cm by 10cm with double-sided tape to be placed on the wall in standardised locations to provide a ferromagnetic surface for the MWA's.
WHO PROVIDED: Magnetic walking aids to be prescribed by a Physiotherapist along with standard walking aid prescription. Standard walking aid prescription involves measuring the walking aid to the patients requirements and providing a demonstration on how to use walking aid safely by a trained physiotherapist.
MODE: In-person face to face during initial physiotherapy mobility assessment
WHERE: The intervention is used throughout participants in-hospital stay. Including the hospital wards and physiotherapy treatment area.
FREQUENCY: The participants that have been allocated to the intervention group are to use their prescribed MWA for the duration of their hospital stay (approximately 8 days).
MEASUREMENT: Mobility aid accessibility will be measured by the number of times the walking aid was dropped on the floor with self-reported logbooks. Mobility aid acceptability will be measured using a follow-up questionnaire at the end of the participant's hospital stay.
TAILORED: N/A
PLANNED: MWA's have been anecdotally trialled with real patients to assess practicality
ACTUAL: The anecdotal study showed people were open to MWA's
Intervention code [1] 320105 0
Treatment: Devices
Intervention code [2] 320106 0
Prevention
Comparator / control treatment
NAME: The control group
WHAT: A standardised elbow crutch and walking stick made of aluminium with no magnetic attachment (SOC).
PROCEDURE: Standard mobility aid prescription by a physiotherapist on how to use an elbow crutch and walking stick. Standard walking aid prescription involves measuring the walking aid to the patients requirements and providing a demonstration on how to use walking aid safely by a trained physiotherapist.
WHO PROVIDED: Provided by a physiotherapist.
MODE: In-person face to face during initial physiotherapy mobility assessment.
WHERE: 'SOC' throughout participants in-hospital stay. Including the hospital wards and physiotherapy treatment area.
FREQUENCY: The participants that have been allocated to the control group are to use their prescribed SOC for the duration of their hospital stay (approximately 8 days).
MEASUREMENT: Mobility aid accessibility will be measured by the number of times the walking aid was dropped on the floor with self-reported logbooks. Mobility aid acceptability will be measured using a follow-up questionnaire at the end of the participants hospital stay.
Control group
Active

Outcomes
Primary outcome [1] 327057 0
Patient acceptability of the magnetic walking aids (MWA) compared to the standard walking aid (SOC), as assessed with a patient questionnaire and staff survey. For example, question 11 on the Follow-up patient questionnaire.
Timepoint [1] 327057 0
Patient acceptability of the MWA to be assessed by patient questionnaire on discharge (approx. 8xdays)

.
Primary outcome [2] 327998 0
Patient accessibility of the MWA compared to the SOC, as assessed with a patient questionnaire and the ‘number of times walking aid dropped’ form. For example, question 6 on the follow up patient questionnaire.
Timepoint [2] 327998 0
Patient accessibility of the MWA to be documented daily during the course of the patients admission on the self reported form 'number of times walking aid dropped' and submitted on discharged.
Primary outcome [3] 327999 0
Staff acceptability of the MWA compared to the SOC, as assessed with staff survey.
Timepoint [3] 327999 0
Staff acceptability of the MWA to be assessed by staff survey at the conclusion of the study once all 40 participants have completed the study.
Secondary outcome [1] 393646 0
The number of occasions MWA's come to rest on the floor accidentally compared to the SOC as reported in the 'number of times walking aid dropped’ form
Timepoint [1] 393646 0
To be documented daily during the course of the admission on the self reported form 'number of times walking aid dropped' and submitted on discharged.

Eligibility
Key inclusion criteria
Inpatient Requiring a Walking stick or Elbow crutch to mobilize.
Total hip or total knee replacement within the last 4 weeks.
Exclude cognitively impaired, nil stroke, nil Parkinson’s Disease.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitively impaired based on past medical history on admission.
Not mobilizing with either a walking stick, elbow crutch or axillary crutch prior to admission hospital.
Does not have the strength to pull the magnetic walking aid off the wall.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants are randomly allocated by an individual external from the study. This external person selects an envelope at random from 40 concealed black envelopes. Inside each black envelop are 20 envelopes labelled ‘MWA’ and 20 envelopes labelled ‘SOC’.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a coin toss to allocate subjects into groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Primary: Descriptive statistics from the completed questionnaires and logbooks will be used to explore the acceptability and accessibility of the MWAs compared to the SOC. For continuous data, independent samples t-tests will be used to compare between the MWA and SOC groups.

Secondary: The number of times the walking aid is dropped will be compared between groups using independent samples t-tests.
A comparison between Control (SOC) and Intervention group (MWA) in the parallel trial, in terms of the number of times per day a walking stick comes to rest accidentally on the floor. This will be filled out each day on self-reported questionnaires completed by the study participants. Regression analysis will be used to determine which patient characteristics are most significant in predicting the number of drops as well as to predict how well the MWA is accepted. For logistic regression this will be expressed in terms of odds ratios.
Acceptability of the MWAs from the staff perspective will be explored using descriptive statistics from the completed staff questionnaire.
Any falls during the intervention period will be collected from the medical record to inform a power calculation for a future large-scale trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2021
Actual
13/08/2021
Date of last participant enrolment
Anticipated
30/09/2021
Actual
8/04/2022
Date of last data collection
Anticipated
30/09/2021
Actual
17/04/2022
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19050 0
Wolper Jewish Hospital - Woollahra
Recruitment postcode(s) [1] 33598 0
2025 - Woollahra

Funding & Sponsors
Funding source category [1] 308200 0
Hospital
Name [1] 308200 0
Wolper Jewish Hospital
Country [1] 308200 0
Australia
Primary sponsor type
Hospital
Name
Wolper Jewish Hospital
Address
8 Trelawney St, Woollahra NSW 2025
Country
Australia
Secondary sponsor category [1] 309404 0
None
Name [1] 309404 0
Address [1] 309404 0
Country [1] 309404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308181 0
Wolper Jewish Hospital Medical Advisory Commitee
Ethics committee address [1] 308181 0
8 Trelawney St, Woollahra NSW 2025
Ethics committee country [1] 308181 0
Australia
Date submitted for ethics approval [1] 308181 0
06/04/2021
Approval date [1] 308181 0
05/05/2021
Ethics approval number [1] 308181 0
X000001

Summary
Brief summary
The goal of this innovation is to reduce in hospital trip hazards, improve nursing staff utilisation on the wards, increase mobility aid adherence, increase adherence to post-operative orthopaedic precautions. With the bottom-line to reduce the number of risk factors that lead to in hospital falls. To test the effectiveness of this innovation I would like to propose a pilot study with hospital-based intervention research design. With a follow-up questionnaire to allow for comparisons to be made between the intervention and the control group.
Trial website
n/a
Trial related presentations / publications
N/A
Public notes
n/a

Contacts
Principal investigator
Name 109830 0
Mrs Alexander Roberts
Address 109830 0
Wolper Jewish Hospital
8 Trelawney St, Woollahra NSW 2025
Country 109830 0
Australia
Phone 109830 0
+61435754766
Fax 109830 0
Email 109830 0
[email protected]
Contact person for public queries
Name 109831 0
Mrs Alex Roberts
Address 109831 0
Wolper Jewish Hospital
8 Trelawney St, Woollahra NSW 2025
Country 109831 0
Australia
Phone 109831 0
+61435754766
Fax 109831 0
Email 109831 0
[email protected]
Contact person for scientific queries
Name 109832 0
Mrs Alex Roberts
Address 109832 0
Wolper Jewish Hospital
8 Trelawney St, Woollahra NSW 2025
Country 109832 0
Australia
Phone 109832 0
+61435754766
Fax 109832 0
Email 109832 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
IPD will not be shared for this trial as the goal of the trial is to look at the broader affect of magnetic walking aids on reducing falls and increasing mobility adherence.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11258Study protocol    381693-(Uploaded-30-09-2022-18-29-27)-Study-related document.docx
11259OtherPatient Follow Up questionnaire MWA   Patient Follow Up questionnaires Staff Follow up ... [More Details] 381693-(Uploaded-07-09-2021-19-00-17)-Study-related document.docx
11619OtherStaff Follow up survey    Patient Follow Up questionnaires Staff Follow up ... [More Details] 381693-(Uploaded-07-09-2021-19-13-02)-Study-related document.docx
11620OtherPatient daily logbook: Number of Times Walking Aid Dropped Form    Patient Follow Up questionnaires Staff Follow up ... [More Details] 381693-(Uploaded-09-05-2021-17-56-51)-Study-related document.pdf
11628Ethical approval    381693-(Uploaded-10-05-2021-09-15-18)-Study-related document.pdf
16327OtherPatient Follow Up questionnaire SWA   Patient Follow Up questionnaires Staff Follow up ... [More Details] 381693-(Uploaded-07-09-2021-19-13-02)-Study-related document.docx



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.