Drug-Resistant EpilepsyNCT07745608
Occupational Therapy Approach in ARX-Related Epilepsy
A study testing Occupational Therapy and Medikal Ketogenic Diet Therapy in people with Drug-Resistant Epilepsy and ARX-Related Epilepsy, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Drug-Resistant Epilepsy, ARX-Related Epilepsy
- What is being tested?
- Occupational Therapy and Medikal Ketogenic Diet Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ilk Evre Special Education and Rehabilitation Center
Istanbul, Istanbul, 34418
About this study
Official title: Evidence-Based Ketogenic Diet Applications in Individuals With ARX Gene Mutation and Epilepsy: An Occupational Therapy Perspective
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.
- Conditions
- Drug-Resistant Epilepsy, ARX-Related Epilepsy
- Being tested
- Occupational Therapy, Medikal Ketogenic Diet Therapy
- Keywords
- ARX Gene Mutation, Ketogenic Diet, Occupational Therapy, Motor Performance, Sensory Processing, Chewing Performance, Eating Behavior, Health-Related Quality of Life, Seizure Frequency
- Medical subject headings
- Drug Resistant Epilepsy, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyBehavioural
Participants received individualized occupational therapy sessions twice weekly for 16 weeks. The intervention was planned according to each child's clinical and functional needs and addressed motor performance, balance, sensory processing, feeding-related skills, chewing performance, and participation in daily activities.
Medikal Ketogenic Diet TherapyOther
Participants in the experimental arm continued medical ketogenic diet therapy prescribed and monitored by their clinical neurology and nutrition teams. The ketogenic diet was not initiated or assigned by the occupational therapy researcher.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Grup (Ketogenic Diet Plus Occupational Therapy) | Experimental | Participants in this arm continued their routine neurological follow-up and prescribed antiseizure medications. They also continued medical ketogenic diet therapy and received occupational therapy for 16 weeks. Receives: Behavioral: Occupational Therapy; Other: Medikal Ketogenic Diet Therapy |
| Control Group (Occupational Therapy Without Ketogenic Diet) | Active comparator | Participants in this arm continued their routine neurological follow-up and prescribed antiseizure medications. They did not receive medical ketogenic diet therapy and received occupational therapy for 16 weeks. Receives: Behavioral: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weekly Seizure Frequency
Weekly seizure frequency was calculated from caregiver-recorded seizure diaries. The mean weekly seizure frequency was determined using seizure records collected over the preceding two months. Lower values indicate fewer seizures.
Measured: Baseline, week 8 and week 16
Change in Pediatric Quality of Life Inventory (PedsQL) Total Score
Health-related quality of life was assessed using the age-appropriate parent-proxy versions of the Pediatric Quality of Life Inventory (PedsQL 4.0). The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life. Change in total score was evaluated across the three assessment time points.
Measured: Baseline, week 8 and week 16
Secondary outcomes (5)
Change in Pediatric Balance Scale Total Score
Functional balance was assessed using the Pediatric Balance Scale, a 14-item performance-based measure. The total score ranges from 0 to 56, with higher scores indicating better functional balance. Changes in total score were evaluated across the three assessment time points.
Measured: Baseline, week 8 and week 16
Change in Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Total Motor Composite Score
Motor performance was assessed using the complete form of the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2). The test includes eight motor subtests. The Total Motor Composite score was used in the analysis, with higher scores indicating better overall motor performance.
Measured: Baseline, week 8 and week 16
Change in Karaduman Chewing Performance Scale Score
Chewing performance was assessed using the Karaduman Chewing Performance Scale, an observational classification ranging from 0 to 4. A score of 0 indicates normal and functional chewing performance, whereas a score of 4 indicates the most severe chewing impairment. Lower scores indicate better chewing performance. Changes in score were evaluated across the three assessment time points.
Measured: Baseline, week 8 and week 16
Change in Selected Children's Eating Behaviour Questionnaire (CEBQ) Subscale Scores
Eating behaviors were assessed using the parent-reported Children's Eating Behaviour Questionnaire (CEBQ), which consists of items rated on a 5-point Likert scale from 1 (never) to 5 (always). Four subscales were evaluated in this study: Enjoyment of Food, Food Responsiveness, Emotional Undereating, and Food Fussiness. Each subscale was scored and analyzed separately; no overall or composite CEBQ score was calculated. Higher Enjoyment of Food and Food Responsiveness scores, and lower Emotional Undereating and Food Fussiness scores, were interpreted as more favorable changes in the context of this study. Changes in the four subscale scores were evaluated across the three assessment time points.
Measured: Baseline, week 8 and week 16
Change in Selected Dunn Sensory Profile Subscale Scores
Sensory processing was assessed using the parent-reported Dunn Sensory Profile. Selected sensory pattern, sensory processing, and behavioral response subscales were evaluated. Each subscale was scored and analyzed separately; no overall composite score was calculated. Higher scores indicate that the behaviors described in the relevant sensory processing domain occur more frequently. Changes in the selected subscale scores were evaluated across the three assessment time points.
Measured: Baseline, week 8 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start2 Feb 2026
- Primary completion25 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Resistant EpilepsyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to two parallel groups according to their existing ketogenic diet status. Both groups received occupational therapy for 16 weeks. The experimental group continued medical ketogenic diet therapy, while the control group did not receive ketogenic diet therapy.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sevda Asqarova, PhD, Study director, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745608
- Sponsor's protocol ID
- USKUDAR-ARX-OT-1882
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the small sample size, the rarity of the condition, and concerns regarding participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Ketogenic Diet Applications in Individuals With ARX Gene Mutation and Epilepsy: An Occupational Therapy Perspective
- ClinicalTrials.gov ID
- NCT07745608
- Acronym / sponsor ID
- USKUDAR-ARX-OT-1882
- Conditions
- Drug-Resistant Epilepsy, ARX-Related Epilepsy
- Keywords
- ARX Gene Mutation, Ketogenic Diet, Occupational Therapy, Motor Performance, Sensory Processing, Chewing Performance, Eating Behavior, Health-Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 4 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to two parallel groups according to their existing ketogenic diet status. Both groups received occupational therapy for 16 weeks. The experimental group continued medical ketogenic diet therapy, while the control group did not receive ketogenic diet therapy.
| Arm | Type | Receives |
|---|---|---|
| Experimental Grup (Ketogenic Diet Plus Occupational Therapy) | Experimental | Behavioral: Occupational Therapy, Other: Medikal Ketogenic Diet TherapyParticipants in this arm continued their routine neurological follow-up and prescribed antiseizure medications. They also continued medical ketogenic diet therapy and received occupational therapy for 16 weeks. |
| Control Group (Occupational Therapy Without Ketogenic Diet) | Active comparator | Behavioral: Occupational TherapyParticipants in this arm continued their routine neurological follow-up and prescribed antiseizure medications. They did not receive medical ketogenic diet therapy and received occupational therapy for 16 weeks. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Occupational TherapyParticipants received individualized occupational therapy sessions twice weekly for 16 weeks. The intervention was planned according to each child's clinical and functional needs and addressed motor performance, balance, sensory processing, feeding-related skills, chewing performance, and participation in daily activities. | Behavioural | Control Group (Occupational Therapy Without Ketogenic Diet), Experimental Grup (Ketogenic Diet Plus Occupational Therapy) |
| Medikal Ketogenic Diet TherapyParticipants in the experimental arm continued medical ketogenic diet therapy prescribed and monitored by their clinical neurology and nutrition teams. The ketogenic diet was not initiated or assigned by the occupational therapy researcher. | Other | Experimental Grup (Ketogenic Diet Plus Occupational Therapy) |
Primary outcome
Change in Weekly Seizure Frequency
Time frame: Baseline, week 8 and week 16
Weekly seizure frequency was calculated from caregiver-recorded seizure diaries. The mean weekly seizure frequency was determined using seizure records collected over the preceding two months. Lower values indicate fewer seizures.
Change in Pediatric Quality of Life Inventory (PedsQL) Total Score
Time frame: Baseline, week 8 and week 16
Health-related quality of life was assessed using the age-appropriate parent-proxy versions of the Pediatric Quality of Life Inventory (PedsQL 4.0). The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life. Change in total score was evaluated across the three assessment time points.
5 secondary outcomes
Change in Pediatric Balance Scale Total Score
Time frame: Baseline, week 8 and week 16
Change in Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Total Motor Composite Score
Time frame: Baseline, week 8 and week 16
Change in Karaduman Chewing Performance Scale Score
Time frame: Baseline, week 8 and week 16
Change in Selected Children's Eating Behaviour Questionnaire (CEBQ) Subscale Scores
Time frame: Baseline, week 8 and week 16
Change in Selected Dunn Sensory Profile Subscale Scores
Time frame: Baseline, week 8 and week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the small sample size, the rarity of the condition, and concerns regarding participant confidentiality.
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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. This study is not recruiting at the moment.
Sevda Asqarova, PhD study director
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy and Medikal Ketogenic Diet Therapy in people with Drug-Resistant Epilepsy and ARX-Related Epilepsy, run by Uskudar University at 1 site in Turkey (Türkiye).
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weekly Seizure Frequency (time frame: Baseline, week 8 and week 16). 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 7 Aug 2026.