Effectiveness of Robot-Assisted Upper Extremity Rehabilitation in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- QUEST (Quality of Upper Extremity Skills Test)
研究概览
简要总结
The use of robotic rehabilitation, a treatment method for improving the motor functions of the upper extremities, is gradually increasing in children with cerebral palsy.
The aim of this study is to investigate the effect of robot-assisted rehabilitation for the upper extremity on upper extremity functions, manual skills and quality of life in patients with unilateral or bilateral/triplegic spastic cerebral palsy and also to compare the effect of robot-assisted upper extremity rehabilitation compared to traditional rehabilitation methods.
详细描述
In this study, it was planned to include 42 patients diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy, aged 5-15 years, who were treated in the Pediatric Rehabilitation Service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and met the inclusion criteria.
Participants will be divided into two groups as study and control groups. In addition to the conventional rehabilitation program, the study group will be included in the robot-assisted upper extremity rehabilitation program, while the control group will be included in the conventional rehabilitation program only.
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes. The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes in addition to the conventional rehabilitation program. Participants will receive a total of 4 weeks of treatment. Assessments will be made before initiating treatment, at the end of treatment, and 3 months after initiation of treatment.
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
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy
- •Be between the ages of 5-15
- •Levels I, II and III according to the Manual Ability Classification System (MACS)
- •Have sufficient cognitive level, such as the ability to understand and follow simple instructions, and to perform desired tasks
- •The upper extremity dimensions are suitable for the robot
- •Parents and patients aged ≥ 9 years have agreed to participate in the study
排除标准
- •Injection of antispasticity drugs (eg Botox) into upper extremity muscles and/or upper extremity orthopedic surgery in the last 6 months
- •Having musculoskeletal disorders and peripheral nervous system disorders that impair the ability to use the upper extremity robotic system
- •Having severe muscle spasticity and/or contracture
- •Having uncontrolled seizures and/or presence of visually induced seizures
- •Having severe learning difficulties, behavioral problems, skin lesions, visual and/or hearing difficulties that may affect function and participation
结局指标
主要结局
QUEST (Quality of Upper Extremity Skills Test)
时间窗: Change from baseline Quality of upper extremity skills test at 4 weeks and 3 months
It is a test developed to measure upper extremity functions. It consists of 7 sub-headings including dissociated movements, grasping, weight bearing, protective extension, hand function rating, spasticity rating and cooperativeness rating.
次要结局
- ABILHAND-Kids(Change from baseline ABILHAND-Kids at 4 weeks and 3 months)
- Box and Block Test(Change from baseline Box and Block Test at 4 weeks and 3 months)
- KINDL (Questionnaire to assess Health-Related Quality of Life in children and adolescents)(Change from baseline KINDL at 4 weeks and 3 months)
- Modified Ashworth Scala (MAS)(Change from baseline Modified Ashworth Scala at 4 weeks and 3 months)