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Abdominal Functional Electrical Stimulation to reduce respiratory complications in spinal cord injury

Abdominal Functional Electrical Stimulation to reduce respiratory complications in spinal cord injury: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000214235
Enrollment
105
Registered
2018-02-09
Start date
2018-08-20
Completion date
2025-10-15
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 hypothesi

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.

Sponsors

Neuroscience Research Australia
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026