Artificial Int: Neurogenic Bowel Education in Spinal Cord Injury Patients (ArtInt)

January 17, 2026 updated by: Senem Duman

Artificial Intelligence Application of Neurogenic Bowel Training in Patients With Spinal Cord Injury

The aim of this study is to evaluate the effectiveness of patient education delivered through an artificial intelligence (AI)-based mobile application in the management of neurogenic bowel dysfunction in individuals with spinal cord injury. Within the scope of the study, it will be examined whether the mobile application reduces neurogenic bowel scores, contributes to maintaining stool scores within the normal range, and improves the quality of life of individuals. Accordingly, the AI-based education model to be developed is expected to facilitate the integration of bowel management practices into daily life, prevent complications, and enhance social participation.

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Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteers who consent to participate.
  • Age over 18 years.
  • Diagnosed with spinal cord injury (SCI).
  • Diagnosed with neurogenic bowel dysfunction (NBD).
  • Not in spinal shock (return of the bulbocavernosus reflex).
  • Having received routine NBD education at the study center within the last month.

Exclusion Criteria:

  • Individuals with mental retardation.
  • Individuals with visual and/or hearing impairments.
  • Individuals with communication problems.
  • Individuals with a history of additional injuries other than SCI (e.g., head trauma, pelvic injury, pelvic surgery).
  • Individuals diagnosed with neurological disorders such as stroke, Parkinson's disease, polyneuropathy, or multiple sclerosis.
  • Individuals with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).
  • Individuals diagnosed with gastrointestinal malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group consisted of participants who only received the hospital's routine NBD education. No additional intervention was provided. The NBD education was delivered by clinical nurses. At the end of the 4th and 12th weeks, the links for the post-tests were sent to the participants in the control group via WhatsApp messages to their phones. After the completion of the study, a link to the mobile application was also provided to the control group via WhatsApp along with an explanatory note.
Experimental: intervention group
İndividuals in the intervention group will receive the same routine education as the control group. In addition to the routine education, on the day of discharge, a link will be sent to their phones through which the mobile application will be downloaded. Participants will create an account in the mobile application by entering their name, surname, and password. The purpose of installing the mobile application on the day of discharge is to prevent individuals in the control group from becoming aware of the mobile application. After discharge, participants will be followed up during the 4th and 12th weeks.
Other: Mobil Application
After discharge, the documents to be completed will be delivered to the intervention group participants via the mobile application and to the control group participants via WhatsApp. At the end of the study, after the final assessment is completed, participants will be informed of their group allocation, and those in the control group will be provided with access to the mobile application via a WhatsApp link.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neurogenic Bowel Dysfunction (NBD) Score Assessed by the Neurogenic Bowel Dysfunction Scale
Time Frame: Baseline (Week 0), Week 4, and Week 12

Neurogenic bowel dysfunction will be assessed using the Neurogenic Bowel Dysfunction (NBD) Scale, a validated questionnaire for individuals with spinal cord injury.

The scale ranges from 0 to 47 points, with higher scores indicating more severe bowel dysfunction.

The outcome measure is the change in total NBD score from baseline (Week 0) to Week 12.
Baseline (Week 0), Week 4, and Week 12
Change in Bowel Care Time Measured in Minutes
Time Frame: Baseline (Week 0), Week 4, and Week 12

Bowel care time will be measured as the average time (in minutes) required to complete bowel care management.

Time will be self-reported by participants. The outcome measure is the change in bowel care time from baseline (Week 0) to Week 12.
Baseline (Week 0), Week 4, and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fecal Incontinence Rate
Time Frame: Baseline (Week 0), Week 4, and Week 12

Fecal incontinence will be assessed based on self-reported occurrence of fecal incontinence episodes.

The outcome will be expressed as the percentage of participants experiencing fecal incontinence at baseline (Week 0), Week 4, and Week 12.
Baseline (Week 0), Week 4, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senem Duman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

August 27, 2025

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SaglikBilimleriU-1
  • Ethics Committee (Other Identifier: Marmara University Faculty of Dentistry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As the process cannot be anticipated, no plan has been established.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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