Occupational Therapy Approach in ARX-Related Epilepsy

Uskudar University20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug-Resistant Epilepsy ARX-Related Epilepsy

Interventions

Occupational TherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ilk Evre Special Education and Rehabilitation Center

Istanbul, Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline, week 8 and week 16

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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