Occupational Therapy Approach in ARX-Related Epilepsy
Turkey (Türkiye)20 participantsStarted 2026-02-02
Plain-language summary
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.
Who can participate
Age range
4 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Severe communicative or cognitive limitations that could prevent valid and reliable administration of the assessment tools.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Weekly Seizure Frequency
Timeframe: Baseline, week 8 and week 16
2
Change in Pediatric Quality of Life Inventory (PedsQL) Total Score