Artificial Int: Neurogenic Bowel Education in Spinal Cord Injury Patients

NCT07369349 | Not Yet Recruiting DMC

• 2 other identifiers: SaglikBilimleriU-1Ethics Committee
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. \-

Conditions

Spinal Cord Injury; Neurogenic Bowel Dysfunction

Keywords

spinal cord injury; neurogenic bowel dysfunction; Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

• Change in Neurogenic Bowel Dysfunction (NBD) Score Assessed by the Neurogenic Bowel Dysfunction Scale

  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

  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 Outcomes (1)

• Change in Fecal Incontinence Rate

  Baseline (Week 0), Week 4, and Week 12

Study Arms (2)

Control Group

NO INTERVENTION

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.

intervention group

EXPERIMENTAL

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

Interventions

Mobil Application OTHER

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.

intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Senem Duman: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Zuhal Associate Professor

CONTACT

+90 505 253 86 29; zuhalozisler@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: January 27, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share