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

Description

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.

Conditions

Spinal Cord Injuries, Neurogenic Bowel

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Englewood

Craig Hospital, Englewood, Colorado, United States, 80113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Chronic SCI (\> 12 months since injury) above the level of T11
  • 2. \> 18 years of age
  • 3. 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.
  • 4. Portable smart device with video capabilities and internet access
  • 5. Willingness to access and/or download Zoom (videoconferencing software)
  • 1. American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E
  • 2. Self-reported bowel management time (BMT) of \<30 minutes
  • 3. Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis
  • 4. Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)
  • 5. Stoma or colostomy
  • 6. No response to AFES (e.g., lower motor neuron impairment)
  • 7. History of gastrointestinal surgery within the past 3 months
  • 8. Severely obese participants (\>40 BMI)
  • 9. Primary language other than English
  • 10. Previous history of uncontrolled, recurrent episodes of AD
  • 11. Resting systolic blood pressure (BP) reported as \>140 mmHg

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Craig Hospital,

Study Record Dates

2025-12