Spinal Cord InjuryArtIntNCT07369349
Artificial Int: Neurogenic Bowel Education in Spinal Cord Injury Patients
A study testing Mobil Application in people with Spinal Cord Injury and Neurogenic Bowel Dysfunction, run by Senem Duman.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Neurogenic Bowel Dysfunction
- What is being tested?
- Mobil Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
-
- Conditions
- Spinal Cord Injury, Neurogenic Bowel Dysfunction
- Being tested
- Mobil Application
- Keywords
- spinal cord injury, neurogenic bowel dysfunction, Artificial Intelligence
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobil ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mobil Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0), Week 4, and Week 12
Secondary outcomes (1)
Change in Fecal Incontinence Rate
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.
Measured: Baseline (Week 0), Week 4, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start20 Feb 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senem Duman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senem Duman, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369349
- Sponsor's protocol ID
- SaglikBilimleriU-1
- Other IDs
- Ethics Committee
- Acronym
- ArtInt
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the process cannot be anticipated, no plan has been established.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Application of Neurogenic Bowel Training in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07369349
- Acronym / sponsor ID
- ArtInt / SaglikBilimleriU-1
- Conditions
- Spinal Cord Injury, Neurogenic Bowel Dysfunction
- Keywords
- spinal cord injury, neurogenic bowel dysfunction, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Senem DumanUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
-
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Mobil Applicationİndividuals 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobil ApplicationAfter 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. | Other | intervention group |
Primary outcome
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.
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.
1 secondary outcome
Change in Fecal Incontinence Rate
Time frame: Baseline (Week 0), Week 4, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. As the process cannot be anticipated, no plan has been established.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mobil Application in people with Spinal Cord Injury and Neurogenic Bowel Dysfunction, run by Senem Duman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zuhal Associate Professor (+90 505 253 86 29, zuhalozisler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neurogenic Bowel Dysfunction (NBD) Score Assessed by the Neurogenic Bowel Dysfunction Scale (time frame: Baseline (Week 0), Week 4, and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.