Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06345781

Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury

Led by Craig Hospital · Updated on 2026-03-31

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Craig Hospital

Lead Sponsor

N

Neuroscience Research Australia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of abdominal functional electrical stimulation (FES) to improve bowel management time for people living with chronic spinal cord injury (SCI). The study aims to assess whether this stimulation can also enhance bowel-related quality of life, participant-reported bowel function, bowel management strategies, bladder symptoms, and reduce unplanned hospital admissions. Participants' experiences and perspectives about the stimulation sessions and device use will also be explored. All participants in this trial will receive abdominal functional electrical stimulation, where electrodes are applied to the abdomen during bowel routines to assess its effects. The intervention lasts for 10 weeks, with daily monitoring of bowel management time and safety. Stimulation dose is tracked during weeks 3 to 7, and participants complete various questionnaires at weeks 1, 3, 7, and 10 to evaluate quality of life, bowel function, bladder symptoms, and intervention acceptability. Participants will be involved in daily bowel management assessments and safety monitoring over the 10-week period. They will complete several questionnaires about their bowel and bladder symptoms, quality of life, and intervention experience at specific weeks. The study uses video-enabled smart devices and videoconferencing software to support data collection. The primary outcome measured is bowel management time, with multiple secondary outcomes to understand the broader impact of the stimulation.

CONDITIONS

Brief Title

Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic spinal cord injury above the T11 level for more than 12 months
  • Age 18 years or older
  • Measurable and consistent start and end events for bowel routine (e.g., enema insertion, digital stimulation, hot drink, abdominal massage)
  • Access to a portable smart device with video and internet capabilities
  • Willingness to access or download Zoom videoconferencing software
Not Eligible

You will not qualify if you...

  • American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E
  • Self-reported bowel management time of less than 30 minutes
  • Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis
  • Physical obstacles preventing abdominal functional electrical stimulation (e.g., pregnancy, abdominal trauma, cardiac pacemaker, implanted electromedical devices)
  • Presence of stoma or colostomy
  • No response to abdominal functional electrical stimulation (e.g., lower motor neuron impairment)
  • Gastrointestinal surgery within the past 3 months
  • Severe obesity (BMI greater than 40)
  • Primary language other than English
  • Previous uncontrolled, recurrent episodes of autonomic dysreflexia
  • Resting systolic blood pressure over 140 mmHg

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - 10 weeks

Participants receive abdominal functional electrical stimulation during their bowel program to assess effects on bowel management time.

Daily sessions during Weeks 1 to 10, with stimulation applied during Weeks 3 to 7

Trial Site Locations

Total: 1 location

1

Craig Hospital

Englewood, Colorado, United States, 80113

Actively Recruiting

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Research Team

C

Candy Tefertiller

B

Bria Mellick

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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