Examination of the Instant Effect of DAFO Use on Balance and Lower Extremity Gross Motor Functions in Individuals With Spastic Diplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Wii Balance Board
研究概览
简要总结
" Study will investigate the immediate effect of DAFO usage on balance and gross motor functions in individuals with spastic diplegic cerebral palsy. The study is planned to be conducted with children aged 4-15 who have GMFCS levels 1 and 2 and who are willing to participate along with their families at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center. During the dates of the study, children who meet the inclusion criteria will be evaluated. Demographic information such as age, height, and weight will be obtained for the participating children. To classify the gross motor levels of the children, the Gross Motor Function Classification System (GMFCS), the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills will be used. In addition, the Gross Motor Function Measure (GMFM-88) items D and E for assessing motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be assessed in two different ways: with and without DAFO. Data analysis will be conducted by a blinded statistician who is not part of the research team. IBM SPSS 26 (Statistical Package for Social Sciences) will be used for statistical analysis of the data. Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. If continuous variables follow a normal (parametric) distribution, paired sample t-tests will be conducted on pre-test and post-test data. If the data are non-parametric, Wilcoxon test will be used. Pearson chi-square test or Spearman correlation coefficient will be used to determine the relationship between variables based on assumptions. Results will be evaluated at a significance level of p < 0.05 with a 95% confidence interval."
详细描述
Cerebral Palsy (CP) is a group of motor disorders resulting from non-progressive damage to the immature brain, leading to movement and posture impairments. Approximately 2 to 3 out of every 1000 children worldwide are born with CP. Prevalence studies conducted before 1990 reported an increasing trend in CP prevalence. However, prevalence is not static, and improvements in prenatal care due to advancements in healthcare have led to a slight decrease in prevalence. A study in 2013 reported a prevalence rate between 2.2% and 2.3%.
Children with CP exhibit various symptoms such as contractures, spasticity, and coordination disorders, mainly affecting the musculoskeletal and nervous systems. These symptoms adversely affect their mobility, functional abilities, and quality of life.
CP is classified into three types based on movement disorder: spastic, dyskinetic, and ataxic, and into four classes based on the pattern of involvement: quadriplegic, hemiplegic, diplegic, and monoplegic. Among these, diplegic CP is the most common type, accounting for 30-35% of cases. Diplegic CP primarily affects the lower extremities more than the upper extremities. Children with diplegic CP often exhibit a pathological gait characterized by pes equinovarus, genu valgus, excessive knee flexion, increased hip adduction, and internal rotation.
The management of CP involves physiotherapy, orthotic support, surgeries, temporary medical interventions, and speech-language therapy. Orthoses, such as Ankle-Foot Orthoses (AFOs), are commonly used in CP rehabilitation. Dynamic Ankle-Foot Orthoses (DAFOs) have emerged as a popular alternative to AFOs in diplegic CP. DAFOs are designed to control muscle tone and prevent foot deformities by providing proper support to the foot's plantar surface. They allow for partial movement due to their flexible and thinner structure compared to rigid AFOs.
Studies have shown that DAFOs significantly impact gross motor skills in children with CP. DAFOs aim to manage foot deformities, increase support, facilitate skill training, and improve mobility during standing and walking.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with Spastic Diplegic type of cerebral palsy
- •Age between 4 and 15 years
- •Using bilateral Dynamic Ankle-Foot Orthosis (DAFO)
- •Communication Function Classification System (CFCS) level between 1 and 2
- •Gross Motor Function Classification System (GMFCS) level between 1 and 2
- •Willingness to participate in the study
排除标准
- •Having experienced lower extremity fractures or muscle-tendon and bone surgery in the past 6 months, or having undergone spinal or orthopedic surgery affecting the lower extremities
- •Exposure to any pharmacological agent or intervention inhibiting spasticity in the past 6 months.
结局指标
主要结局
Wii Balance Board
时间窗: day 1
The Wii Balance Board transmits vertical ground reaction forces from four corners of the device to the Wii system via Bluetooth when an individual stands on it. The Fizyosoft Balance System, developed by engineers and physiotherapists, will be used to assess static balance in participating children. Swing speeds measured using the Wii Balance Board, which establishes a Bluetooth connection with a computer, will be indexed. The dimensions of the Wii Balance Board are approximately 45 x 26.5 cm, with a weight capacity of approximately 150 kg. Children will be instructed to stand on the device with their feet parallel to each other and remain motionless for 15 seconds, with measurements taken with eyes open and closed. The coordinates of the individuals' center of pressure (COPx, COPy) will be recorded in centimeters (cm), while the performance value will be recorded as a percentage in the system.""A high deviation from the x and y coordinates indicates poor balance."
"The Gross Motor Function Measure-88 (D-E) (GMFM-88)
时间窗: day 1
To assess changes in lower extremity gross motor function in children with cerebral palsy, the D (Standing) and E (Walking/Running/Jumping) sections of the GMFM-88 test will be used. The D section consists of 12 questions ranging from 52 to 64, and the E section consists of 23 questions ranging from 65 to 88. A total of 35 questions will be evaluated""Low scores indicate poor gross motor function."
The Functional Reach Test
时间窗: day 1
The Functional Reach Test is a dynamic balance assessment method. It measures the maximum distance that can be reached forward and sideways while standing upright. The reached distance is calculated as the difference between the maximum distance reached while standing upright without lifting the heels from the ground and the maximum distance reached while maintaining hip flexion without lifting the heels from the ground. This method, commonly used in adults, is employed to evaluate the ability to maintain balance and stability. Studies have shown that this test, designed for adults, can also be applied to children.Low scores indicate poor balance.
"The Pediatric Berg Balance Scale (PBBS)
时间窗: day 1
The Pediatric Berg Balance Scale (PBBS) is a test consisting of 14 questions related to parameters such as standing up from sitting, standing, transfers, walking, turning, etc. Each question is scored from 0 to 4, and the time taken to perform the desired activity is recorded. At the end of the test, the total score obtained by the individual is calculated and recorded. Validity and reliability studies of this scale have been conducted for various neurological diseases such as Parkinson's disease, stroke, spinal cord injuries, etc., as well as for geriatrics.""Higher scores indicate better balance levels."
次要结局
- "The Gross Motor Function Classification System (GMFCS)(day 1)
- "The Communication Function Classification System (CFCS)(day 1)
- "The Eating and Drinking Ability Classification System (EDACS)(day 1)
- "The Manual Abilities Classification System (MACS)(day 1)
研究者
Seda AYAZ TAŞ
Principal Investigator
Abant Izzet Baysal University