Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000305426
Ethics application status
Approved
Date submitted
24/09/2024
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Balance and Abdominal Functional Electrical Stimulation in People with
Chronic Spinal Cord Injury
Scientific title
Evaluating the effect of Abdominal Functional Electrical Stimulation on Sitting Balance in Community Dwelling people with SCI
Secondary ID [1] 313036 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paralysis 335257 0
Spinal Cord Injury 335255 0
Tetraplegia 335256 0
Condition category
Condition code
Neurological 331828 331828 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 331829 331829 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 331830 331830 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Qualifying participants will be asked to attend two study sessions on two separate days at least 3 but no more than 10 business days apart. Participants will be asked to not alter their routines relating to exercise and will be asked to not directly practice the items related to the FIST-SCI in the interim period between assessments. Every effort will be made to schedule participants at similar times during the day to minimize variability in participant balance response from factors external to the study. Individuals who qualify for this study and provide consent will perform the Function in Sitting Test for people with SCI (FIST-SCI) in two conditions: 1) with abdominal FES and 2) with abdominal functional electrical stimulation (FES) pads applied but not turned on. Only one condition will be completed per study session. The order of condition will be randomly determined by picking out of a hat. The assessor will be blinded to the condition. A separate member of the study team will apply the electrodes and will either turn the stimulation device on (active condition) or keep the device off (sham condition) based on the randomization chosen. The stimulation device will then be put in a bag that will keep the assessor blinded to the stimulator. The unblinded study team member will record the stimulation settings of the active condition and the condition order on a case report form (CRF) that will not be accessed by the blind assessor.

For the active abdominal FES condition, electrical current will be adjusted until a strong, visible, and tolerable muscle contraction is observed (typically 50 to 100 mA) like previous studies completed by researchers at NeuRA. Stimulation will be delivered by the Empi (Continuum, Empi, 199610-001). The Empi is a clinically available stimulation device and is currently being used in an approved study (ACTRN12621000386831). The Empi device delivers electric stimulation through electrode pads place postereolaterally on the trunk. When turned on the device will cause a contraction of the underlying muscles. The device will remain on throughout one of the two full balance assessments. We anticipate the first session will take 45-60 minutes at most. We anticipate the second session will take 20-40 minutes at most.
Intervention code [1] 329673 0
Treatment: Devices
Comparator / control treatment
The electrical current will ramp up to a sub motor threshold to create a similar sensation to the active condition however it will not illicit the same response. Each participant will receive the sham and the active stimulation.
Control group
Active

Outcomes
Primary outcome [1] 339449 0
Seated balance score
Timepoint [1] 339449 0
Immediately after each of the active and sham conditions
Secondary outcome [1] 440033 0
Perception of difference in physiological balance when abdominal functional electrical stimulation is applied compared to sham intervention
Timepoint [1] 440033 0
Immediately after each of the active and sham conditions
Secondary outcome [2] 440310 0
Maximal Balance Range
Timepoint [2] 440310 0
once in each condition after the FIST-SCI.

Eligibility
Key inclusion criteria
1. At least 18 years of age
2. Non-acute SCI, community dwelling person with SCI for at least 6 months
3. Motor Level at the level of T5 or above
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-wheelchair user or regular ambulator
2. No response to abdominal functional electrical stimulation (AFES) or unable to tolerate at intensity needed to evoke a contraction
3. Physical obstacles that prevent use/placement of AFES
4. Implanted pacemaker/ defibrillator or other implanted devices that prevent placement
of electrodes
5. Unable t0 assume a sitting position due to current wound or orthostatic intolerance
6. Unable to follow three step commands or cannot comprehend the required balance tasks
7. Women who are pregnant

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation carried out by the unmasked rater
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
All participants will receive both conditions however in different order to keep the rater masked.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis using the FIST-SCI minimal detectable change for the chronic SCI population of 4, accounting for power of 90% and an alpha of 0.05, requires 32 participants. We will recruit 37 individuals to account for 15% attrition. A paired T-test will analyze the balance response to Abdominal Functional Electrical Stimulation in our sample. This is an appropriate sample size as it will allow for the recruitment of a broad spectrum of people with various neurologic levels of injury and impairment or completeness levels.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 26573 0
United States of America
State/province [1] 26573 0
Miami

Funding & Sponsors
Funding source category [1] 317478 0
Government body
Name [1] 317478 0
NSW Health
Country [1] 317478 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Country
Australia
Secondary sponsor category [1] 319770 0
None
Name [1] 319770 0
Address [1] 319770 0
Country [1] 319770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316192 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 316192 0
Ethics committee country [1] 316192 0
Australia
Date submitted for ethics approval [1] 316192 0
08/11/2022
Approval date [1] 316192 0
18/11/2022
Ethics approval number [1] 316192 0
HC220708

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137086 0
Prof Jane Butler
Address 137086 0
Neuroscience Research Australia (NeuRA), Margarete Ainsworth Building, 139 Barker Street Randwick NSW 2031
Country 137086 0
Australia
Phone 137086 0
+61 293991005
Fax 137086 0
Email 137086 0
[email protected]
Contact person for public queries
Name 137087 0
Annie Palmero
Address 137087 0
Neuroscience Research Australia (NeuRA), Margarete Ainsworth Building, 139 Barker Street Randwick NSW 2031
Country 137087 0
Australia
Phone 137087 0
+61 293991827
Fax 137087 0
Email 137087 0
[email protected]
Contact person for scientific queries
Name 137088 0
Annie Palmero
Address 137088 0
Neuroscience Research Australia (NeuRA), Margarete Ainsworth Building, 139 Barker Street Randwick NSW 2031
Country 137088 0
Australia
Phone 137088 0
+61 293991827
Fax 137088 0
Email 137088 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• All

Conditions for requesting access:
• -

What individual participant data might be shared?
• All study data

What types of analyses could be done with individual participant data?
• IPD meta-analysis

When can requests for individual participant data be made (start and end dates)?
From:
Upon publication, no end date post publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• unrestricted access via publication

Are there extra considerations when requesting access to individual participant data?
No


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.