OCCUPATİONAL THERAPY APPROACH İN ARX-RELATED EPİLEPSY | NCT07745608

NCT07745608

Overview

NCT ID: NCT07745608
Lead Sponsor: Uskudar UniversityOTHER
Official Title: EVIDENCE-BASED KETOGENIC DIET PRACTICES IN INDIVIDUALS WITH ARX GENE MUTATION AND EPILEPSY: AN OCCUPATIONAL THERAPY PERSPECTIVE
Brief 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.
Conditions: ARX Gene Mutation
Drug-Resistant Epilepsy

Status and Timeline

Status: Completed
Last Update Posted: Aug 4, 2026Actual
Start Date: Feb 2, 2026Actual
Primary Completion Date: May 25, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 20Actual
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: No data available
Locations: Ilk Evre Special Education and Rehabilitation Center

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Control Group (Occupational Therapy Without Ketogenic Diet)Active Comparator

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