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Trial registered on ANZCTR


Registration number
ACTRN12618000214235
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
9/02/2018
Date last updated
15/11/2019
Date data sharing statement initially provided
29/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Abdominal Functional Electrical Stimulation to reduce respiratory complications in spinal cord injury
Scientific title
Abdominal Functional Electrical Stimulation to reduce respiratory complications in spinal cord injury: a randomised controlled trial
Secondary ID [1] 293942 0
None
Universal Trial Number (UTN)
U1111-1208-8261
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 306439 0
Condition category
Condition code
Neurological 305525 305525 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 305526 305526 0 0
Other physical medicine / rehabilitation
Respiratory 305527 305527 0 0
Other respiratory disorders / diseases
Injuries and Accidents 305561 305561 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The abdominal muscles are the primary muscle group used during forced exhalation. We have shown that surface Functional Electrical Stimulation (FES) of the abdominal muscles, termed Abdominal FES, can improve respiratory function and assist weaning from mechanical ventilation in spinal cord injury. While respiratory function is directly linked to likelihood of respiratory complications in spinal cord injury, evidence that Abdominal FES reduces respiratory complications is anecdotal. We hypothesise that Abdominal FES will reduce the likelihood of respiratory complications in the acute (<6 weeks post injury) stage of spinal cord injury.

Two hundred and forty participants will be recruited to this multi-site randomised, placebo controlled pilot trial. Participants with a new cervical spinal cord injury will be recruited 5-10 days post injury. 120 patients will be randomly allocated to receive Abdominal FES and 120 will receive a placebo. In the Abdominal FES group, Abdominal FES will be applied for 45 minutes per day, 5 days per week, for 5 weeks.

Specifically, Abdominal FES will be delivered, via electrodes placed over the posterolateral surface of the abdomen. The stimulation amplitude will initially be set to 60 mA (50 Hz), which corresponds to 90% of the maximum amplitude that was tolerated by healthy volunteers in a previous study. If this amplitude results in discomfort to the patient (based on clinical judgement) then it will be reduced as necessary.Stimulation amplitude will be evaluated every 5 minutes to ensure that stimulation is still tolerable and causing a suitable muscle contraction. Stimulation will be applied by a local physiotherapist at each site.
Intervention code [1] 300209 0
Treatment: Devices
Comparator / control treatment
Participants in the placebo group will receive sham Abdominal FES for 45 minutes per day, five days per week, for 5 weeks. Placebo Abdominal FES will be similar to active FES in all respects except for the simulation intensity, which will be kept to a level which does not cause a muscle contraction.

Specifically, stimulation pulses will be delivered at a frequency of 10 Hz and at a low current amplitude (< 10 mA) that does not cause abdominal muscle contraction. These settings were chosen so that participants experience the sensation of Abdominal FES without an abdominal muscle contraction. The placebo will be applied by a local physiotherapist at each site.
Control group
Placebo

Outcomes
Primary outcome [1] 304652 0
proportion of patients suffering a respiratory complication (pneumonia, atelectasis, pleural effusion) in the first six weeks of tetraplegia, as reported by the patient's clinican
Timepoint [1] 304652 0
six weeks post cervical spinal cord injury
Secondary outcome [1] 342671 0
Forced Vital Capacity, measured using spirometry
Timepoint [1] 342671 0
one, three, six and 12 weeks post injury
Secondary outcome [2] 342672 0
Quality of life, measured using SF-36 Survey
Timepoint [2] 342672 0
one, six and 12 weeks post injury
Secondary outcome [3] 342673 0
Mortality, recorded from patient's medical record
Timepoint [3] 342673 0
12 weeks post cervical spinal cord injury
Secondary outcome [4] 342788 0
Forced Expiratory Volume in one Second, measured using spirometry
Timepoint [4] 342788 0
one, six and 12 weeks post injury
Secondary outcome [5] 342789 0
Peak Expiratory Flow, measured using spirometry
Timepoint [5] 342789 0
one, six and 12 weeks post injury
Secondary outcome [6] 342790 0
Maximum Inspiratory Pressure, measured using spirometry
Timepoint [6] 342790 0
one, six and 12 weeks post injury
Secondary outcome [7] 342791 0
Maximum Expiratory Pressure, measured using spirometry
Timepoint [7] 342791 0
one, six and 12 weeks post injury

Eligibility
Key inclusion criteria
5-10 days post cervical spinal cord injury (i.e. tetraplegia)
post definitive spinal surgery, where indicated
no respiratory complications in previous 24 hours (screening out iatrogenic complications)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- mechanical ventilation dependency
- American Spinal Injuries Association Impairment Scale D
- progressive neurological disease or chronic respiratory disease
- physical obstacles that prevent Abdominal FES (e.g. pregnancy, abdominal trauma, pacemaker)
- no response to Abdominal FES (e.g. lower motor neuron impairment)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be randomly assigned to active or placebo Abdominal FES in a 1:1 ratio using a random, secure, web-based program (REDCap) by an independent investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A Chi-squared test to determine the effect of Abdominal FES on respiratory complications

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 9930 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [2] 9931 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 14320 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 15165 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 18741 0
2031 - Randwick
Recruitment postcode(s) [2] 18742 0
2065 - St Leonards
Recruitment postcode(s) [3] 27322 0
6150 - Murdoch
Recruitment postcode(s) [4] 28467 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 9546 0
United Kingdom
State/province [1] 9546 0
Scotland
Country [2] 9547 0
Thailand
State/province [2] 9547 0
Chang Mai
Country [3] 9549 0
India
State/province [3] 9549 0
Delhi, Vellore
Country [4] 22117 0
Canada
State/province [4] 22117 0
Alberta, Hamilton
Country [5] 22118 0
New Zealand
State/province [5] 22118 0
Auckland

Funding & Sponsors
Funding source category [1] 298570 0
Government body
Name [1] 298570 0
National Health and Medical Research Council
Address [1] 298570 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 298570 0
Australia
Funding source category [2] 299411 0
Charities/Societies/Foundations
Name [2] 299411 0
Wings for Life
Address [2] 299411 0
Fürstenallee 4
5020 Salzburg
Austria
Country [2] 299411 0
Austria
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 297721 0
None
Name [1] 297721 0
Address [1] 297721 0
Country [1] 297721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299536 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 299536 0
Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Ethics committee country [1] 299536 0
Australia
Date submitted for ethics approval [1] 299536 0
29/03/2018
Approval date [1] 299536 0
28/05/2018
Ethics approval number [1] 299536 0
18/086

Summary
Brief summary
The primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can reduce the rate of respiratory complications in acute tetraplegia. The secondary objectives of this study are to analyse whether this intervention also affects: (1) respiratory function, (2) quality of life and (3) mortality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80766 0
Dr Euan McCaughey
Address 80766 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 80766 0
Australia
Phone 80766 0
+61293991827
Fax 80766 0
Email 80766 0
e.mccaughey@neura.edu.au
Contact person for public queries
Name 80767 0
Dr Euan McCaughey
Address 80767 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 80767 0
Australia
Phone 80767 0
+61293991827
Fax 80767 0
Email 80767 0
e.mccaughey@neura.edu.au
Contact person for scientific queries
Name 80768 0
Dr Euan McCaughey
Address 80768 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 80768 0
Australia
Phone 80768 0
+61293991827
Fax 80768 0
Email 80768 0
e.mccaughey@neura.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Upon publication, with no end limit
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
Through supplementary information in open access publication
What supporting documents are/will be available?
No other documents available
Summary results
No Results