Evidence-Based Ketogenic Diet Applications in Individuals With ARX Gene Mutation and Epilepsy: An Occupational Therapy Perspective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Weekly Seizure Frequency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental Grup (Ketogenic Diet Plus Occupational Therapy)
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.
干预措施: Medikal Ketogenic Diet Therapy (Other)
Experimental Grup (Ketogenic Diet Plus Occupational Therapy)
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.
干预措施: Occupational Therapy (Behavioral)
Control Group (Occupational Therapy Without Ketogenic Diet)
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.
干预措施: Occupational Therapy (Behavioral)
结局指标
主要结局
Change in Weekly Seizure Frequency
时间窗: 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
时间窗: 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.
次要结局
- Change in Selected Children's Eating Behaviour Questionnaire (CEBQ) Subscale Scores(Baseline, week 8 and week 16)
- Change in Pediatric Balance Scale Total Score(Baseline, week 8 and week 16)
- Change in Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Total Motor Composite Score(Baseline, week 8 and week 16)
- Change in Karaduman Chewing Performance Scale Score(Baseline, week 8 and week 16)
- Change in Selected Dunn Sensory Profile Subscale Scores(Baseline, week 8 and week 16)