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Completed

NCT Number: NCT07745608

Occupational Therapy Approach in ARX-Related Epilepsy

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.

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Key information

Conditions

Drug-resistant Epilepsy ARX-Related Epilepsy Behavior Behavior, Animal Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Feeding Behavior Nervous System Diseases

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ilk Evre Special Education and Rehabilitation Center

Istanbul, 34418, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

occupational therapy

Behavioral

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 Therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Pediatric Balance Scale Total Score

    Time frame: Baseline, week 8 and week 16

    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.

  2. Change in Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Total Motor Composite Score

    Time frame: Baseline, week 8 and week 16

    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.

  3. Change in Karaduman Chewing Performance Scale Score

    Time frame: Baseline, week 8 and week 16

    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.

  4. Change in Selected Children's Eating Behaviour Questionnaire (CEBQ) Subscale Scores

    Time frame: Baseline, week 8 and week 16

    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.

  5. Change in Selected Dunn Sensory Profile Subscale Scores

    Time frame: Baseline, week 8 and week 16

    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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

Evidence-Based Ketogenic Diet Applications in Individuals With ARX Gene Mutation and Epilepsy: An Occupational Therapy Perspective

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2026
Registry last updated
Aug 7, 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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