Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury
Craig Hospital
15 participants
Apr 30, 2025
INTERVENTIONAL
Conditions
Summary
The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device.
Eligibility
Inclusion Criteria7
- Chronic SCI (\> 12 months since injury) above the level of T11
- \> 18 years of age
- a measurable and consistent start and end event is determinable for the bowel routine
- Start events include: 1) enema insertion, 2) digital stimulation, 3) hot drink or initiation of the gastrocolic reflex, 3) abdominal massage, or 4) other, as determined by the participant and research team.
- Ending events include: 1) final digital stimulation, 2) when evacuation has ceased, or 3) other, as determined by the participant and research team.
- Portable smart device with video capabilities and internet access
- Willingness to access and/or download Zoom (videoconferencing software)
Exclusion Criteria11
- American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E
- Self-reported bowel management time (BMT) of \<30 minutes
- Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis
- Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)
- Stoma or colostomy
- No response to AFES (e.g., lower motor neuron impairment)
- History of gastrointestinal surgery within the past 3 months
- Severely obese participants (\>40 BMI)
- Primary language other than English
- Previous history of uncontrolled, recurrent episodes of AD
- Resting systolic blood pressure (BP) reported as \>140 mmHg
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Interventions
Functional electrical stimulation electrodes will be applied to the abdomen during a bowel program to assess effects of stimulation on bowel management time.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06345781