NCT07745608Completed
Occupational Therapy Approach in ARX-Related Epilepsy
Evidence-Based Ketogenic Diet Applications in Individuals With ARX Gene Mutation and Epilepsy: An Occupational Therapy Perspective
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
This study evaluated the effects of medical ketogenic diet therapy combined with occupational therapy in children with ARX-related epilepsy. Twenty children were included. Ten children receiving a ketogenic diet formed the experimental group, and ten children not receiving a ketogenic diet formed the control group. Both groups received occupational therapy for 16 weeks. Assessments were performed at baseline, week 8, and week 16. Seizure frequency, motor performance, balance, sensory processing, chewing performance, eating behaviors, and health-related quality of life were evaluated.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 29 Jul 2026
- Start date
- 2 Feb 2026
- Primary completion date
- 25 May 2026
- Lead sponsor
- Uskudar University
- Diseases
- Epilepsy
- NCT number
- NCT07745608
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 2 Feb 2026 to the primary completion date, 25 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of an additional neurological or genetic disorder, other than ARX mutation and epilepsy, that could affect ketogenic diet implementation or assessment outcomes.
- Presence of a severe orthopedic or systemic medical condition that could prevent completion of follow-up and assessments.
Other
- Severe communicative or cognitive limitations that could prevent valid and reliable administration of the assessment tools.
Who the study is looking for
- Age between 4 and 7 years.
- Genetically confirmed ARX gene mutation.
- Diagnosis of drug-resistant epilepsy.
- For the experimental group, initiation of or planned initiation of classical ketogenic diet therapy as part of routine clinical care.
- For the control group, continuation of standard neurological treatment and usual diet without ketogenic diet therapy.
- Eligibility for the target age ranges of the assessment tools used in the study.
- Written informed consent provided by a parent or legal caregiver.
Age in the registry: 4 years to 7 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ilk Evre Special Education and Rehabilitation Center Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.