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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Abdominal Functional Electrical Stimulation
BehavioralFunctional electrical stimulation electrodes will be applied to the abdomen during a bowel program to assess effects of stimulation on bowel management time.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Abdominal Functional Electrical StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Bowel Management Time (BMT)
This is measured by recording start and end time of bowel management session in study diary.
Time frame
Daily (Weeks 1-10)Secondary outcomes
1
Bowel Management Strategy
This will be measured via analysis of daily diary entries regarding bowel movements (time taken and frequency), dietary changes or inconsistencies, and use of laxatives and manual procedures. The bowel diary will be completed daily throughout the study by participants and/or their caregivers.
Time frame
Daily (Weeks 1-10)2
Stimulation Dose
This will be recorded by the participant. Participants will be asked to record the total time of active stimulation as displayed by the stimulation counter/timer and the intensity of the stimulation (milliamps) for each BM session in their bowel diary. The stimulation device will also record number of times the device button is depressed and duration in seconds, which can be downloaded at a later date by the research team providing further detail on stimulation dose.
Time frame
During active stimulation period (Weeks 3-7)3
EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
Quality of Life measure
Time frame
Week 1, Week 3, Week 7, Week 104
International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire
This instrument measures participant-reported bowel function bowel function.
Time frame
Week 1, Week 3, Week 7, Week 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Craig Hospital
Lead sponsor
Neuroscience Research Australia
Collaborator
Source ClinicalTrials.gov