Effects of Fun-Core (Child-Friendly Core Stabilization) Exercises on Balance and Functional Mobility in Children With Spastic Cerebral Palsy: A Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Modified Timed Up & Go Test
研究概览
简要总结
A total of 54 children, aged between 6 and 12 years, diagnosed with hemiplegic cerebral palsy and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2025 and March 1, 2026, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. Children and their parents will be informed verbally and in writing about the study's purpose, duration, and method of implementation, and their informed consent will be obtained. They will be asked to sign an "Informed Consent Form." Patient assessment and follow-up forms will be completed at pre- and post-treatment follow-ups. Patients who meet the inclusion criteria will be numbered according to their order of admission and then randomly assigned to either the intervention or control groups by a computer program.
In addition to a brochure showing the number of sets and repetitions to be given to the patients as a standard home exercise program, the Fun-Core video exercise program, designed as a child-friendly core stabilization exercise program to be performed 3 times a week, will be given to the intervention group (G1), and the exercises will be delivered to the participants through a website with special accounts.
The control group (G2) will receive a standard home exercise program in brochure format, showing the number of sets and repetitions. The exercise program will be performed at home three times a week for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with hemiplegic cerebral palsy between the ages of 6 and 12
- •Children with Gross Motor Function Classification System (GMFCS) Levels 1, 2, and 3
- •Shoe sizes 30 and above
排除标准
- •Cognitive impairments that prevent understanding and performing simple commands and tasks
- •Botulinum toxin injections into the upper and/or lower extremities within the last 6 months
- •History of lower extremity or lumbar surgery within the last year
- •Presence of uncontrolled severe epileptic seizures
- •Presence of severe vision or hearing problems
- •Presence of fixed contractures in the lower extremities
研究组 & 干预措施
Control Group (G2)
Standard home exercise program (brochure)
干预措施: Exercise (Other)
Intervention Group (G1)
In addition to a brochure showing the number of sets and repetitions to be given to the patients as a standard home exercise program, the Fun-Core video exercise program, designed as a child-friendly core stabilization exercise program to be performed 3 times a week, will be given to the intervention group (G1), and the exercises will be delivered to the participants through a website with special accounts.
干预措施: Exercise (Other)
结局指标
主要结局
Modified Timed Up & Go Test
时间窗: Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)
The mTUG test is a modified version of the Timed Up and Go (TUG) test for assessing functional mobility in children. It essentially measures how quickly an individual can perform the skills necessary for daily living activities-sitting, standing, walking, turning, and sitting down again. Unlike the standard TUG test, it includes instructions and environmental conditions tailored to the developmental level and cognitive capacity of children. In our study, the mTUG test will be administered to participants wearing shoes equipped with wearable sensors, and the test duration will be measured through the shoes.
次要结局
- Pediatric Balance Scale(Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment))
- Six Minute Walk Test(Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment))
- Trunk Endurance Tests(Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment))
- Pediatric Reach Test(Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment))
- WeeFIM(Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment))
- PEDQoL 4.0 Pediatric Quality of Life Questionnaire(Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment))
- Children/ Youth with Cerebral Palsy Brief (6-13 years of age)(Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment))
研究者
Berk Korkut
Medical Doctor (Res. Assist. Dr.)
Istanbul University