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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Colorado
Craig Hospital
RECRUITING
Englewood
Contact Information
Primary
Candy Tefertiller
ctefertiller@craighospital.org
303-789-8000
Backup
Bria Mellick
bmellick@craighospital.org
303-789-8757
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2025-12
Participants
Target number of participants: 15
Treatments
Experimental: Abdominal Functional Electrical Stimulation
All participants enrolled will receive the intervention.
Related Therapeutic Areas
Sponsors
Leads: Craig Hospital
Collaborators: Neuroscience Research Australia

This content was sourced from clinicaltrials.gov