ANZCTR - Registration

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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 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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Spinal Cord Injury

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Injuries and Accidents

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]

Treatment: Other

Intervention code [2]

Treatment: Devices

Comparator / control treatment

No abdominal binder

Control group

Active

Outcomes

Primary outcome [1]

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]

6 weeks after mobilization, 3 months, 6 months, 12 months

Secondary outcome [1]

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]

6 weeks after mobilization, 3 months, 6 months, 12 months

Secondary outcome [2]

Mean arterial pressure will be calculated from blood pressure recording taken using the portable OMRON IA2

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Queensland Health Allied Health Research Scholarship

Address [1]

Princess Alexandra Hospital
Ipswich Rd, Woolloongabba 4102
QLD

Country [1]

Australia

Primary sponsor type

Hospital

Name

Princess Alexandra Hospital

Address

Ipswich Rd,
Woolloongabba 4102
Brisbane

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Queensland

Address [1]

School of Rehabilitation and Health Sciences
Sir Fred Schonnell Drive
St Lucia
Brisbane 4072

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Alexandra Hospital

Ethics committee address [1]

Ipswich Rd, Woolloongabba. Brisbane 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/02/2006

Ethics approval number [1]

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

Mrs Brooke Wadsworth

Address

Physiotherapy, Spinal Injuries Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
4102
QLD

Country

Australia

Phone

61 7 31762089

Fax

brooke@chronicpainsolutions.com.au

Contact person for public queries

Name

Brooke Wadsworth

Address

QSCIS
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba 4102

Country

Australia

Phone

61731762089

Fax

61731762009

brooke@chronicpainsolutions.com.au

Contact person for scientific queries

Name

Brooke Wadsworth

Address

QSCIS
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba 4102

Country

Australia

Phone

61731762089

Fax

61731762009

brooke@chronicpainsolutions.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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