Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000797976
Ethics application status
Approved
Date submitted
26/07/2011
Date registered
29/07/2011
Date last updated
7/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Can patients reproduce partial weight bearing orders?
Scientific title
Partial weight bearing in orthopaedic in-patients: ability to reproduce partial weight bearing orders, factors influencing this and effect on clinical outcomes.
Secondary ID [1] 262699 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthopaedic inpatients who are prescribed partial weight bearing as part of their management 270403 0
Condition category
Condition code
Musculoskeletal 270545 270545 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants will receive standard medical, nursing and allied health care during and after their hospital admission. This care, including instruction in partial weight bearing during mobilisation by physiotherapists, will not change as a result of participation in the current study. Our physiotherapists currently use the hand-under-foot or bathroom scale method to instruct patients in partial weight bearing, with the method chosen at the discretion of the treating physiotherapist. Instruction is repeated until the patient and physiotherapist are confident that the patient can reproduce the partial weight bearing orders. Further instruction on subsequent episodes of mobilisation is undertaken as deemed necessary. Additionally, when mobilising patients, physiotherapy staff observe the patient’s style of mobilisation and estimate whether partial weight bearing to the prescribed level is occurring. Repeated instruction is provided for patients when over-loading is suspected.
Instruction in partial weight bearing status will occur only during the period of hospitalisation.
Intervention code [1] 267047 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269290 0
Maximum difference between the target load and actual load will be recorded (in kg) using the SmartStep monitor.
Timepoint [1] 269290 0
Daily weekday basis during the period of hospitalisation.
Primary outcome [2] 269291 0
Mean (standard deviation) weight during the period of mobilisation will also be recorded using the SmartStep monitor.
Timepoint [2] 269291 0
Daily weekday basis during the period of hospitalisation.
Secondary outcome [1] 279312 0
In order to investigate factors that could potentially impact on patients' ability to reproduce partial weight bearing orders, descriptive data will be collected. These data will include age, sex, body mass index, primary diagnosis, medical conditions that could affect patients' ability to perform partial weight bearing (eg, musculoskeletal or neurological conditions), conditions that could affect patients' ability to understand partial weight bearing instructions (eg, English as a second language, cognitive impairment) and pain at the time of mobilisation (measured on a verbal analogue scale where 0 = no pain and 10 = worst pain imaginable). These data will collected by one of the investigators (SK, TM or CJ) from medical records or by questioning the patient.
Timepoint [1] 279312 0
Daily weekday basis during the period of hospitalisation.
Secondary outcome [2] 279313 0
Broad clinical outcomes will be retrieved from data routinely recorded on a form which is completed by orthopaedic surgeons/registrars when patients attend Orthopaedic Outpatient clinics. This form includes information about patients' ability to walk, pain, range of motion, complications and xray findings. Importantly, the latter two points (ie, complications and xray findings) will indicate whether there has been a clinically important loss of fracture reduction and/or implant loosening, which would be the most important adverse effects that might result from excessive weight bearing during the period of fracture healing and/or recovery from orthopaedic surgery.
Timepoint [2] 279313 0
Three months post-injury.

Eligibility
Key inclusion criteria
Adult patients admitted to the Royal Adelaide Hospital with an orthopaedic problem/condition where the management includes the prescription of partial weight bearing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to participate

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
22/02/2012
Date of last participant enrolment
Anticipated
Actual
19/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
47
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267519 0
Hospital
Name [1] 267519 0
Royal Adelaide Hospital Allied Health Research Grant
Country [1] 267519 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 266561 0
None
Name [1] 266561 0
Address [1] 266561 0
Country [1] 266561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269485 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 269485 0
Research Ethics Committee
Level 3, Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 269485 0
Australia
Date submitted for ethics approval [1] 269485 0
26/07/2011
Approval date [1] 269485 0
26/07/2011
Ethics approval number [1] 269485 0
110711

Summary
Brief summary
The main purpose of this study is to determine objectively whether orthopaedic in-patients are able to reproduce partial weight bearing orders by assessing dynamic weight bearing using a highly accurate insole monitor. The study also seeks to investigate factors that influence patients’ ability to accurately reproduce partial weight bearing orders. Finally, the study will investigate, in a preliminary manner, whether the ability to accurately reproduce partial weight bearing orders affects clinical outcomes.
Trial website
Trial related presentations / publications
Publication:
Yu S, McDonald T, Jesudason C, Stiller K, Sullivan T (2014) Orthopedic in-patients’ ability to accurately reproduce partial weight bearing orders. Orthopedics 37:e10-e18.

Presentation:
October 2013; Yu S, McDonald T, Jesudason C, Stiller K, Sullivan T (2013)
Orthopaedic in-patients’ ability to reproduce partial weight bearing orders: factors influencing this and effect on clinical outcomes. An observational study. Australian Physiotherapy Association Physiotherapy Conference, Melbourne, Australia.
Public notes

Contacts
Principal investigator
Name 32923 0
Dr Kathy Stiller
Address 32923 0
Physiotherapy Department Royal Adelaide Hospital North Terrace Adelaide South Australia 5000
Country 32923 0
Australia
Phone 32923 0
61 8 82225334
Fax 32923 0
61 8 82224279
Email 32923 0
[email protected]
Contact person for public queries
Name 16170 0
Dr Kathy Stiller
Address 16170 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 16170 0
Australia
Phone 16170 0
61 8 82225334
Fax 16170 0
61 8 82224279
Email 16170 0
[email protected]
Contact person for scientific queries
Name 7098 0
Dr Kathy Stiller
Address 7098 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 7098 0
Australia
Phone 7098 0
61 8 82225334
Fax 7098 0
61 8 82224279
Email 7098 0
[email protected]

No information has been provided regarding IPD availability


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.