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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Spinal Cord Injury

Tetraplegia

Paralysis

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Injuries and Accidents

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]

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]

Seated balance score

Timepoint [1]

Immediately after each of the active and sham conditions

Secondary outcome [1]

Perception of difference in physiological balance when abdominal functional electrical stimulation is applied compared to sham intervention

Timepoint [1]

Immediately after each of the active and sham conditions

Secondary outcome [2]

Maximal Balance Range

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Miami

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Health

Address [1]

Country [1]

Australia

Primary sponsor type

Other

Name

Neuroscience Research Australia

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

http://www.newcastle.edu.au/research/research-services/human-ethics/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/11/2022

Approval date [1]

18/11/2022

Ethics approval number [1]

HC220708

Summary

Brief summary

The goal of this project to is explore the immediate response of sitting balance and trunk stability to electrical stimulation used to activate the abdominal muscles in people with chronic SCI. This type of electrical stimulation, called functional electrical stimulation, is used on the abdomen or other areas of the body to help people with SCI and other neurological conditions to perform tasks, cough, work out, or strengthen muscles. We plan to study whether functional electrical stimulation activating or turning on the abdominal muscles can alter the sitting balance response compared to having no functional electrical stimulation. We are targeting the abdominal muscles because they are part of the core musculature and play an important role in balance control. Improving balance and trunk stability is a high priority for people with SCI. Balance and trunk stability are crucial to independence in functional activities or activities that people perform every day like dressing, grooming, eating, toileting, and completing transfers. If there is a positive response to abdominal functional electrical stimulation during balance activities, it could be implemented into daily routines of people with SCI because it is a safe and relatively low-cost intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Jane Butler

Address

Neuroscience Research Australia (NeuRA), Margarete Ainsworth Building, 139 Barker Street Randwick NSW 2031

Country

Australia

Phone

+61 293991005

Fax

[email protected]

Contact person for public queries

Name

Annie Palmero

Address

Neuroscience Research Australia (NeuRA), Margarete Ainsworth Building, 139 Barker Street Randwick NSW 2031

Country

Australia

Phone

+61 293991827

Fax

[email protected]

Contact person for scientific queries

Name

Annie Palmero

Address

Neuroscience Research Australia (NeuRA), Margarete Ainsworth Building, 139 Barker Street Randwick NSW 2031

Country

Australia

Phone

+61 293991827

Fax

[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?

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

Documents added manually

Documents added automatically