Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCraig Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Abdominal Functional Electrical Stimulation
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Craig Hospital
Lead sponsor
Neuroscience Research Australia
Collaborator
Source ClinicalTrials.gov