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NCT Number: NCT07369349

Artificial Int: Neurogenic Bowel Education in Spinal Cord Injury Patients

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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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neurogenic Bowel Dysfunction Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zuhal Associate Professor

CONTACT

[email protected]

+90 505 253 86 29

Sponsors and collaborators

Lead sponsor

Senem Duman

Other

Registry information

Official study title

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

Acronym: ArtInt

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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