Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000144213
Ethics application status
Approved
Date submitted
17/08/2008
Date registered
6/03/2009
Date last updated
15/01/2019
Date data sharing statement initially provided
15/01/2019
Date results information initially provided
15/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Abdominal Binder effect on breathing, speech and blood pressure in spinal cord injuries.
Scientific title
Is breathing, speech and blood pressure improved with the use of an abdominal binder in people who have suffered an acute spinal cord injury?
Secondary ID [1] 297078 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 4140 0
Condition category
Condition code
Injuries and Accidents 3727 3727 0 0
Other injuries and accidents
Injuries and Accidents 4343 4343 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will all wear an abdominal binder throughout the study period (there will NOT be two groups with one wearing the AB and one group not). However, testing with and without the abdominal binder will be randomised in order of testing for each time point according to a computer generated randomisation order list of binder on/off. An elastic binder is an elastic garment that wraps around a patients abdomen extending from the bottom of the ribs to just above the hip. It is used when a patient assumes an upright position. Patients are provided with an abdominal binder when they first commence sitting up in a wheelchair after acute injury. Patients are advised to continue the use of an abdominal binder if they have no motor activation of the abdominal muscles. Outcome measures will be collected over 4 points in time during the subjects first 12 months after a spinal cord injury.
Intervention code [1] 3284 0
Treatment: Other
Intervention code [2] 3853 0
Treatment: Devices
Comparator / control treatment
No abdominal binder
Control group
Active

Outcomes
Primary outcome [1] 4630 0
Respiratory function-
Vital capacity (VC), forced vital capacity in one second (FEV1), Peak expiratory flow (PEF) will be measured using a handheld SpiroPro machine.

Maximum expiratory pressure (MEP)and maximum inspiratory pressure (MIP) will be measured using a Micro Medical MicroRPM machine
Timepoint [1] 4630 0
6 weeks after mobilization, 3 months, 6 months, 12 months
Secondary outcome [1] 7826 0
Speech function - Sustained phonation, loudness range, conversational speech quality will be measured using the Edirol device. Data analysis will be carried out by trained blinded Speech Pathologists.
Timepoint [1] 7826 0
6 weeks after mobilization, 3 months, 6 months, 12 months
Secondary outcome [2] 8805 0
Mean arterial pressure will be calculated from blood pressure recording taken using the portable OMRON IA2
Timepoint [2] 8805 0
6 weeks after mobilization, 3 months, 6 months, 12 months

Eligibility
Key inclusion criteria
Acute spinal cord injury above T12, Amercian Spinal Injuries Association (ASIA) classification system of ASIA classification A or B which indicates complete motor dennervation below level.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pressure sore of stage 2 or greater, active respiratory disease

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Within subject design, Subjects will have outcomes collected with and without abdominal binder in place when seated.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
1/07/2009
Date of last data collection
Anticipated
Actual
7/07/2010
Sample size
Target
20
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 4309 0
Government body
Name [1] 4309 0
Queensland Health Allied Health Research Scholarship
Country [1] 4309 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Ipswich Rd,
Woolloongabba 4102
Brisbane
Country
Australia
Secondary sponsor category [1] 3881 0
University
Name [1] 3881 0
The University of Queensland
Address [1] 3881 0
School of Rehabilitation and Health Sciences
Sir Fred Schonnell Drive
St Lucia
Brisbane 4072
Country [1] 3881 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6356 0
Princess Alexandra Hospital
Ethics committee address [1] 6356 0
Ipswich Rd, Woolloongabba. Brisbane 4102
Ethics committee country [1] 6356 0
Australia
Date submitted for ethics approval [1] 6356 0
Approval date [1] 6356 0
23/02/2006
Ethics approval number [1] 6356 0
2005/079

Summary
Brief summary
Patients who experience spinal cord injury loose normal function of respiratory muscles leaving them particularly vulnerable to respiratory complications, loss of optimal speech function and potential development of secondary postural deformities. Gravity, in conjunction with increased abdominal muscle compliance, pulls downward on the diaphragm resulting in flattening of the diaphragm, which reduces its ability to drive respiration. Abdominal binders limit abdominal wall distension when against gravity (sitting in wheelchair) by replacing the non-functioning abdominal muscle (innervated T5-T12) role. The restoration of diaphragm position may assist with improved respiration, speech and blood pressure when a patient is sitting in his/her wheelchair.
This study will investigate the effect of an abdominal binder on breathing, speech and blood pressure in newly injured patients admitted to the Spinal Injuries Unit of Princess Alexandra Hospital. Those patients that have suffered an injury resulting in damage to T12 level or above and presenting as a complete injury will be approached.

The current practice in the Spinal Injuries Unit is to wean the abdominal binder once the cardiovascular system has adapted and postural hypotension is no longer a concern. However, the abdominal binder has been shown to have an effect on respiratory function.

Respiratory, speech and blood pressure measurements will be taken with and without the binder on in sitting at 6weeks post initial mobilizing,12 weeks,24weeks ,and 48 weeks after this point. The results of this study will be analyzed to determine the effect of binder use on outcomes collected. These results will direct further practice and use of the abdominal binder.
Trial website
Trial related presentations / publications
http://www.archives-pmr.org/article/S0003-9993%2812%2900433-9/pdf
Public notes

Contacts
Principal investigator
Name 28853 0
Mrs Brooke Wadsworth
Address 28853 0
Physiotherapy, Spinal Injuries Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
4102
QLD
Country 28853 0
Australia
Phone 28853 0
61 7 31762089
Fax 28853 0
Email 28853 0
brooke@chronicpainsolutions.com.au
Contact person for public queries
Name 12010 0
Mrs Brooke Wadsworth
Address 12010 0
QSCIS
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba 4102
Country 12010 0
Australia
Phone 12010 0
61731762089
Fax 12010 0
61731762009
Email 12010 0
brooke@chronicpainsolutions.com.au
Contact person for scientific queries
Name 2938 0
Mrs Brooke Wadsworth
Address 2938 0
QSCIS
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba 4102
Country 2938 0
Australia
Phone 2938 0
61731762089
Fax 2938 0
61731762009
Email 2938 0
brooke@chronicpainsolutions.com.au

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.