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โ† Trials
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Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury

RecruitingNAAges 18 Years - anyAllCraig Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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) Exclusion Criteria: 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
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What it tests

  • Abdominal Functional Electrical Stimulation
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Where

1 site
Craig Hospital
Englewood, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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