The Effect of Robotic Hand Therapy on Hand Functions and Quality of Life in Children With Cerebral Palsy: A Randomized Controlled Study
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
- 2
- 主要终点
- MACS (Manual Ability Classification System for Children with Cerebral Palsy)
研究概览
简要总结
Cerebral palsy (CP) is the most common physical disability in childhood. The term CP is defined as a group of persistent but non-progressive movement and posture disorders resulting from a defect or lesion of the immature brain. The overall prevalence of CP worldwide is 2.11 per 1000 live births.
There is evidence that 80% of children with CP have upper extremity involvement. In general, the acquisition of effective arm and hand skills for use in daily life is a complex process that not only requires neuromusculoskeletal integrity, but also includes various aspects of the child's abilities. Thus, in addition to the positive symptoms that typically present patterns of spasticity, children and adolescents with CP often have a poor ability to reach, grasp, release, and manipulate objects. They also have difficulty using their upper extremities to perform self-care and other activities.
Robot-assisted and computer-assisted methods may be valuable new strategies for improving the sensory-motor learning process in children with central motor impairment. These new technologies represent an attractive complement to existing physiotherapeutic and occupational therapy concepts.
In patients with difficulty in individual finger and hand movements, the AMADEO device (Tyromotion, Austria) can be used for unilateral distal training of the upper extremity. With this device, patients with little or no voluntary control of the hand and fingers can receive more or less passive training, while those with better distal function of the upper extremity can strength train by following the device or even against the device to a certain extent.
Implementation of robot-assisted therapy provides intense repetitive training, sensorimotor integration and cognitive engagement through targeted tasks; focuses primarily on functional motor performance. From previous studies, the use of robotic devices has been found to improve the kinematics, range of motion, muscle tone, postural control, and functionality of the upper and lower extremities in individuals with CP. Robotic hand therapy has started to take place in routine rehabilitation protocols today. Considering the scarcity of studies on robotic hand therapy in the pediatric group, larger-scale studies are needed. In this study, our aim is to investigate the effect of robotic hand therapy on hand functions and quality of life in children with CP.
详细描述
Cerebral palsy (CP) is the most common physical disability in childhood. The term CP is defined as a group of persistent but non-progressive movement and posture disorders resulting from a defect or lesion of the immature brain. The overall prevalence of CP worldwide is 2.11 per 1000 live births.
There is evidence that 80% of children with CP have upper extremity involvement. In general, the acquisition of effective arm and hand skills for use in daily life is a complex process that not only requires neuromusculoskeletal integrity, but also includes various aspects of the child's abilities. Thus, in addition to the positive symptoms that typically present patterns of spasticity, children and adolescents with CP often have a poor ability to reach, grasp, release, and manipulate objects. They also have difficulty using their upper extremities to perform self-care and other activities.
Robot-assisted and computer-assisted methods may be valuable new strategies for improving the sensory-motor learning process in children with central motor impairment. These new technologies represent an attractive complement to existing physiotherapeutic and occupational therapy concepts.
In patients with difficulty in individual finger and hand movements, the AMADEO device (Tyromotion, Austria) can be used for unilateral distal training of the upper extremity. With this device, patients with little or no voluntary control of the hand and fingers can receive more or less passive training, while those with better distal function of the upper extremity can strength train by following the device or even against the device to a certain extent.
Implementation of robot-assisted therapy provides intense repetitive training, sensorimotor integration and cognitive engagement through targeted tasks; focuses primarily on functional motor performance. From previous studies, the use of robotic devices has been found to improve the kinematics, range of motion, muscle tone, postural control, and functionality of the upper and lower extremities in individuals with CP.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •grade 1-3 according to the manual ability classification system
- •capable of taking multi-step commands
- •able to sit in a chair
排除标准
- •Having persistent pain in the upper extremity or hand (VAS>40)
- •with severe spasticity of the hand (MAS≥3) or contracture
- •Fracture or operation in the upper extremity in the past 6 months
- •Botulinum toxin injection to the upper extremity in the last 6 months
- •skin ulcer
- •severe vision and hearing impairment
- •intense ataxia
- •uncontrolled epilepsy
结局指标
主要结局
MACS (Manual Ability Classification System for Children with Cerebral Palsy)
时间窗: 15 minutes
It is designed to classify how children with CP aged 4-18 use their hands while manipulating objects in daily life. The starting point of MACS is in upper extremity function, but it is also influenced by environmental, personal and contextual factors. It is designed to reflect the child's typical manual performance. MACS is a five-level system where level I represents the best dexterity and level V indicates that the child is not using their hands for functional purposes. It is intended to indicate the level that best represents the child's usual performance at home, school, and community settings. The Turkish version of the MACS has been found to be valid and reliable and is recommended to be suitable for the assessment of manual dexterity in the Turkish population.
Spasticity Evaluation
时间窗: 5 minutes
It was planned to evaluate spasticity with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in flexion and extension.
次要结局
- Jamar Dynamometer(5 minutes)
- Nine Hole Peg Test(30 minutes)
- Jebsen Taylor Hand Function Test(45 minutes)
- ABILHAND- Kids Manual Ability Scale(30 minutes)
- Quality of Life Scale for Children - SP Module (PedsQL-CP)(30 minutes)
- Box Block Test(75 minutes)
- Pediatric Functional Independence Measurement(30 minutes)
- Fugl Meyer Upper Extremity Assessment Questionnaire(15 minutes)
研究者
Sevda Adar
assistant professor
Afyonkarahisar Health Sciences University