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临床试验 NCT07049523 针对脑瘫目前尚未招募。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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Robotic Exoskeleton Gait Training for Children With Cerebral Palsy 36
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临床试验NCT07049523是一项针对脑瘫的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年10月1日开始，预计招募36名患者。该研究由Hunan Normal University主导，计划于2027年3月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年7月8日。
简要概括
The goal of this clinical trial is to evaluate whether robotic-assisted gait training can improve motor function, walking capacity, joint flexibility, muscle structure, and psychological well-being in children aged 6 to 12 years with spastic cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) level IV.
The main questions it aims to answer are:
Can robotic gait training improve gross...
显示更多详细描述
Cerebral palsy (CP) remains the most common motor disability in childhood, affecting approximately 17 million people worldwide, with an estimated 2-3 per 1,000 live births. In China alone, the number of children with CP is estimated to exceed 6 million, with approximately 40,000 new cases occurring each year. Notably, a substantial proportion of these children are classified as Gross Motor Function Classification Sys...显示更多
官方标题
Protocol for the "Stand the Future" Trial: Robotic Exoskeleton Gait Training for Non-Ambulatory Children With Spastic Cerebral Palsy
疾病
脑瘫出版物
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
- 2025-506
NCT编号
实际开始日期
2025-10-01
最近更新发布
2025-07-08
预计完成日期
2027-03-01
计划入组人数
36
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
fascicle length
muscle volume
motor development
gait
rehabilitation
muscle volume
motor development
gait
rehabilitation
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预Regular rehabilitation Participants assigned to the regular rehabilitation (control) group will continue receiving their usual care as determined by their caregivers. Usual care may include activities such as home-based stretching, passive range-of-motion exercises, school-based physiotherapy, or outpatient therapy. There will be no restrictions on care choices. | 不适用 |
实验性Robotic-assisted gait training The intervention group will receive robotic-assisted gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot (RoboCT Limited Co., Hangzhou, China), a pediatric exoskeleton system designed for overground locomotor training. | Robotic-assisted gait training The intervention group will receive robotic-assisted gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot (RoboCT Limited Co., Hangzhou, China), a pediatric exoskeleton system designed for overground locomotor training. This device integrates real-time motion sensing, adaptive control algorithms, and customizable joint actuation to deliver precise and individualized gait training for children with...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Gross Motor Function Measure - Item Set (GMFM-IS) | Gross motor function will be evaluated using the Gross Motor Function Measure - Item Set (GMFM-IS), a validated short-form tool derived from the full GMFM-66, appropriate for assessing changes in children with CP (Russell et al., 2010). It focuses on key motor tasks across five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. In this study, trained evaluators will observe children as they perform selected motor tasks from the GMFM-IS. Each task will be scored on a 4-point ordinal scale: 0 = does not initiate; 1 = initiates (\<10% of the task); 2 = partially completes (10-99%); 3 = completes the task independently. The assessment will take place in a quiet, controlled environment with standardized instructions and safety precautions. Scores will be entered into the Gross Motor Ability Estimator software to generate interval-level total scores, allowing for sensitive tracking of changes in motor function over time. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
1-minute walk test | To assess functional walking capacity, participants will undergo the 1-minute walk test, performed on a marked 20-meter indoor course. Children will be instructed to walk as quickly and safely as possible without running, and the total distance covered in 60 seconds will be recorded. For participants who require orthoses or walkers, such assistive devices will be permitted during testing, consistent with real-world functionality. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
Passive ankle joint range of motion | Passive ankle joint range of motion (ROM) will be measured using an isokinetic dynamometer. Each child will be seated with the knee fully extended, the ankle joint aligned with the dynamometer's rotational axis, and the foot securely fixed to a footplate. Passive dorsiflexion and plantar flexion will be conducted through full available range to determine ROM and passive torque. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
Muscle morphological properties | Muscle morphological properties of the lower limbs will be assessed via ultrasonography using a 6-12 MHz linear transducer (Meinianda BX-5, Zibo, China). Images will be acquired for the rectus femoris, quadriceps femoris, and medial gastrocnemius on both lower limbs. Standardized anatomical landmarks will be used for probe placement, and muscle thickness and muscle fascicle length will be quantified offline by blinded assessors. | Baseline (week 0) and post-intervention (week 24) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Pediatric Quality of Life Inventory | Psychological satisfaction and treatment engagement will be evaluated using the Pediatric Quality of Life Inventory (PedsQL™ 3.0 NMM), which is validated for children with chronic motor impairments (Iannaccone et al., 2009). This instrument includes child self-report and parent-proxy versions and assesses multiple dimensions including physical functioning, communication, and emotional well-being. Higher scores represent better perceived quality of life and satisfaction with daily function. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
6 Years
适龄性别
全部
- No history of heart disease or family history of heart disease;
- Children classified as GMFCS level IV;
- Dependent on assistive mobility devices, such as wheelchairs or posture support walkers, for activities of daily living;
- Medically stable and able to sit upright for at least 30 minutes;
- Able to understand simple verbal or visual instructions.
- Aged under 6 years or over 12 years;
- Received botulinum toxin A injections for lower limb muscles within six months prior to baseline assessment;
- Implanted with an intrathecal baclofen pump, or has a history of lower limb-related orthopedic or neurosurgical interventions (such as tendon lengthening, osteotomy, or selective dorsal rhizotomy);
- Has uncontrolled epilepsy, severe cognitive impairment, or other comorbidities.
Hunan Normal University研究责任方
Yang Zhang, 主要研究者, Principle scientist, Hunan Normal University
研究中心联系人
联系人: Yang Zhang, PhD, 727-252-9687, [email protected]
联系人: Dinghua Liu, MS, 8618807486231
没有位置数据。