The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury: Single Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Total score of Melbourne Assessment of Unilateral Upper Limb Function
研究概览
简要总结
This study was designed to establish the clinical evidence for effect of video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea, on upper limb function of children with cerebral palsy. First, the investigators would compare the effect of video-game based rehabilitation therapy to conventional occupational therapy.
详细描述
- Purpose: to elucidate the effect of video-game based rehabilitation therapy system on upper limb function of children with cerebral palsy compared to conventional occupational therapy
- Subjects: total 30 children with cerebral palsy whose upper limb functions are impaired (all 30 children will receive the conventional occupational therapy, but 15 of these children will receive the additional video-game based rehabilitation therapy)
- Intervention: 4 weeks of therapy (6 days per week)
- Studies: functional MRI, computerized motion analysis, upper limb functional assessment (MUUL, ULPRS), ADL evaluation, cognitive evaluation
- Evaluation plan: 1) pre-intervention, 2) post-4 weeks of intervention, 3) 8 weeks after end of intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •MACS (Manual ability classification system) level I, II, III, IV
- •Patients without cognitive impairment who are able to comply with protocol-required procedure
- •male or female, 4 to 18 years
排除标准
- •Patients with cognitive impairment who are unable to comply with protocol-required procedure
- •Patients with significant visual impairment
- •Patients with presence or history of musculoskeletal anomaly who are unable to apply device
研究组 & 干预措施
IMU sensor training group(intervention group)
video-game based rehabilitation therapy system training group
干预措施: digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids) (Device)
Conventional OT group (control group)
conventional training group (control group)
干预措施: Conventional OT group (Other)
结局指标
主要结局
Total score of Melbourne Assessment of Unilateral Upper Limb Function
时间窗: 8 weeks
MUUL is the test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions. It comprises 14 test items of reaching to, grasping, releasing and manipulating simple objects. Scoring is completed for the 30 item scores using a three, four or five point scale and the individually defined scoring criteria. The test will be done by occupational therapist. The total score of MUUL will be used for analysis.
次要结局
- Total score of upper limb physician's rating scale (ULPRS)(8 week)
- Kinematic data of computerized 3D motion analysis(8 week)
- Scaled scores of Pediatric Evaluation of Disability Inventory (PEDI-selfcare)(8 week)