Study of the Effectiveness of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy by Evaluating the 3 Fields of the ICF: A Prospective, Randomized, Controlled, Simple Blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Kinematic
研究概览
简要总结
Cerebral Palsy (CP) is a major cause of impairments in child population. This disease justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised by robotics.
Our team has developed a robot designed to rehabilitate the child's upper limb. This robot allows the patient to perform active, passive, or assisted exercises.
This therapy is designed to promote motor development in children with CP. Its finality is to improve patients' quality of life and participation.
Several pilot studies evaluated the efficacy of robotic assisted therapy in children with CP but none RCT has been done.
Then, the aim of the study is to evaluate the efficacy of robotic-assisted therapy in children with cerebral palsy by evaluating the 3 fields of the ICF (International Classification of Functioning, Disability and Health) and performing a prospective randomized controlled single blind trial. Therefore, all patients will benefit from a classical rehabilitation as a basis. Furthermore, patients of the control and experimental groups will receive a supplement of classical rehabilitation and robotic-assisted therapy, respectively.
详细描述
INTRODUCTION
Cerebral Palsy (CP) is a major cause of impairments in child population. Indeed, CP affects two births per thousand (1). The brain damage is expressed by different neurological impairments and functional disabilities. These disabilities justify intensive and sustained multidisciplinary rehabilitation to reduce neurological impairments, to improve the activities and participation of patients, and, ultimately, their quality of life (2, 3, 4).
Robotics interest has already been shown for lower limb rehabilitation (5). The development of the upper limb rehabilitation robotic devices started later. To better stimulate brain plasticity, these tools meet the actual recommendations existing in CP's rehabilitation (4). Indeed, the robots allow the execution of a large number of movements whose quality is controlled (6). A visual interface gives the patient a feedback of its movements (7), and offers exercises oriented functional tasks that have meaning for him (8) and the possibly dive into a virtual reality. All these elements justify the clinical development of robots to assist the therapists.
In children with CP, several pilot studies have verified the clinical applicability of these tools (9-11). However, no randomized controlled study has been performed to evaluate the effectiveness of robotic-assisted therapy in children with CP (12). Moreover, no study evaluated the effect of these therapies on the three areas of the ICF : Many studies focus on impairments (e.g. muscle) without assessing the functional capacity of the patient: what about their ability in every day life?
OBJECTIVES
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
- 4 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral palsy (hemi, quadri or di-plegia)
- •MACS > 1/5 (moderate to severe impairments)
排除标准
- •Botulinum toxin injection in the upper limb muscles
- •Intrathecal Baclofen for the upper limb spasticity
- •an unstable clinical condition contraindicating the upper limb rehabilitation treatments
- •cognitive disorders preventing the understanding of the instructions
- •other neurological or orthopedic pathology affecting the upper limb.
结局指标
主要结局
Kinematic
时间窗: Change from Baseline in Kinematic at an expected average of 3 months and 6 months
次要结局
- Manual Ability Classification System(Change from Baseline in manual ability at an expected average of 3 months and 6 months)
- Quality of Upper Extremity Skills Test(Change from Baseline in quality of upper extremity skills at an expected average of 3 months and 6 months)
- Box and Block test(Change from Baseline in dexterity at an expected average of 3 months and 6 months)
- strength(Change from Baseline in strength at an expected average of 3 months and 6 months)
- Abilhand-Kids scale(Change from Baseline in activity of daily living at an expected average of 3 months and 6 months)
- Pediatric Evaluation of Disability Inventory(Change from Baseline in activity of daily living at an expected average of 3 months and 6 months)
- MHAVIE(Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months)
研究者
Lejeune
Professor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
