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临床试验 NCT07369167 (EEG_AINCP) 针对脑瘫 (CP)，单侧脑瘫，脑电图 (EEG)，动作观察目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Neural Correlates of Goal-directed Action Observation and Execution in Children With Unilateral Cerebral Palsy (EEG_AINCP) 80 无创 可穿戴设备 观察性
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临床试验NCT07369167 (EEG_AINCP)是一项针对脑瘫 (CP)，单侧脑瘫，脑电图 (EEG)，动作观察的观察研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年1月1日开始，预计招募80名患者。该研究由IRCCS Fondazione Stella Maris主导，计划于2027年7月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年1月27日。
简要概括
Cerebral palsy (CP) is the most common childhood-onset motor disorder, with Unilateral Cerebral Palsy (UCP)- motor impairment predominantly impacting one side of the body-representing the most frequent form of CP. Among available rehabilitation programs, Action Observation Treatment (AOT) has gained increasing attention for its demonstrated effectiveness in improving manual motor function. AOT involves the systematic...显示更多
官方标题
Neurophysiological, Kinematics and Functional Correlates of Goal-directed Action Observation and Execution in Children With Unilateral Cerebral Palsy
疾病
脑瘫 (CP)单侧脑瘫脑电图 (EEG)动作观察出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- EEG_AINCP
NCT编号
实际开始日期
2026-01
最近更新发布
2026-01-27
预计完成日期
2027-07
计划入组人数
80
研究类型
观察研究
试验状态
尚未招募
关键词
Unilateral Cerebral Palsy
Mirror Neuron System
EEG
Mu rhythm
Sensorimotor
eye-tracker
wearable sensors
Action Observation
manual function
UCP
Mirror Neuron System
EEG
Mu rhythm
Sensorimotor
eye-tracker
wearable sensors
Action Observation
manual function
UCP
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Study Group 40 children with Unilateral Cerebral Palsy (UCP), aged 5-15 years | 不适用 |
Control Group 40 typically developing (TD) children, aged 5-15 years | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Neurophysiological (EEG) data | \- Mu-rhythm reactivity during the EEG action-observation task.
Primary outcome measures will be the EEG mu rhythm modulation during the visuo-motor task performed by participants. The EEG mu rhythm suppression (or desynchronization) is an index of the human mirror neuron system activation over the sensorimotor cortex.
Quantitative Spectral and time-frequency analyses will be performed to assess mu-rhythm suppression in response to executed and observed goal-directed actions.
Mu rhythm event-related desynchronization/synchronization (ERD/ERS) patterns will be examined across scalp regions (primary region of interest: central and parietal sites) and conditions (observation, execution) and compared between groups (control group vs study group). | 1 session - about 45 minutes |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Gaze behavior and Attentional engagement - during EEG session | Data on participants' gaze behavior and attentional engagement during EEG recording will be obtained from the eye tracking system. Analyses will focus on eye movements, stimulus fixation duration, and saccades during video observation. Eye-tracking measures will be correlated with EEG indices and compared between groups. | 1 session: about 45 minutes (during EEG acquisition) |
Kinematic data - during EEG session | Data from IMU wearable sensors will be acquired during EEG acquisition. Quantitative parameters for kinematics (i.e., position/trajectories, time, speed); dynamics (acceleration, forces); performance (jerk, accuracy, frequency and amplitude of movement) and symmetry and coordination indexes will be analyzed. These data will be correlated with EEG data and compared between groups. | 1 session: about 45 minutes (during EEG acquisition) |
Score of Assisting Hand Assessment (AHA) | The AHA is a standardized assessment tool to measure the assisting hand performance in children with UCP. It can be used for children aged between 18 months and 18 years, with playful sessions made of semi-structured activities calibrated on different ages (different board games), and lasts approximately 25-30 minutes. The videotaped assessment is subsequently scored by a certified AHA examiner. | 1 session: about 25-30 minutes (before or after EEG session) |
Score of the Melbourne Assessment 2 (MA-2) | The MA-2 is a valid and reliable criterion-referenced test for evaluating upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years. It consists of 14 unimanually tested items including reach, pointing, manipulation, grasp, release, and pro-/supination. Only the affected hand will be tested and it lasts approximately 15 minutes. | 1 session: about 15 minutes (before or after EEG session) |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
5 Years
适龄性别
全部
接受健康志愿者
是
- Children with confirmed diagnosis of Unilateral Cerebral Palsy,
- Manual ability levels from I to III in the Manual Ability Classification System (MACS);
- Children's age from 5 to 15 years old.
- Severe Upper Limb (UpL) impairment (MACS ≥ level IV: inability to grasp),
- UpL surgery within 12 months prior to study entry and botulinum toxin injection within 6 months prior to study entry,
- Severe comobordities,
- Severe cognitive disability, clinically assessed by the cognitive scales Wechsler, Preschool and Primary Scale of Intelligence (WPPSI-IV) or Wechsler Intelligence Scale for Children (WISC-IV or V).
Typically Developing children:
Inclusion Criteria
- 5 to 15 year-old children with typical development,
- No documented clinically relevant disorders
IRCCS Fondazione Stella Maris研究责任方
Giuseppina Sgandurra, 主要研究者, Professor, IRCCS Fondazione Stella Maris
研究中心联系人
联系人: Giuseppina Sgandurra, MD, PhD, +39 050-886233, [email protected]
1 位于 1 个国家/地区的研究中心
Pisa
IRCCS Fondazione Stella Maris, Calambrone, Pisa, 56128, Italy
Giuseppina Sgandurra, MD, PhD, 联系人, +39 050-886233, [email protected]