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临床试验 NCT05899153 针对脑瘫目前招募中。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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华盛顿大学Gait Adaptation and Biofeedback for Cerebral Palsy 36 可穿戴设备
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临床试验NCT05899153是一项针对脑瘫的干预性研究试验，目前试验状态为招募中。试验始于2023年11月28日，计划招募36名患者。该研究由华盛顿大学主导，预计于2029年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年2月7日。
简要概括
This research aims to evaluate walking function in children with cerebral palsy (CP). The researchers want to understand how children with CP adapt and learn new ways of moving. They have previously found that measuring how a person controls their muscles is important for assessing walking ability and response to interventions. In these studies, they will adjust the treadmill belt speeds and/or provide real-time feed...显示更多
详细描述
Prior research has shown that children with cerebral palsy (CP) use simplified motor control strategies compared to nondisabled (ND) peers, and that these differences in motor control are associated with walking function. While we can quantify motor control during activities like walking, the processes by which a child with CP adapts and learns new movement patterns are poorly understood.
This research will use two ...
显示更多官方标题
Quantifying Patient-specific Changes in Neuromuscular Control in Cerebral Palsy: Adaptation and Biofeedback During Gait
疾病
脑瘫其他研究标识符
- STUDY00015348
- R01NS091056 (美国 NIH 拨款/合同)
NCT编号
实际开始日期
2023-11-28
最近更新发布
2025-02-07
预计完成日期
2029-01-01
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
招募中
关键词
Gait
Rehabilitation
Rehabilitation
主要目的
基础研究
分配方式
非随机
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 |
|---|---|
实验性Orthopedic Surgery Participants who have been scheduled for lower-extremity, multilevel orthopedic surgery will be assessed before and 9-18 months after surgery to evaluate changes in gait and adaptation rates. | Multilevel Orthopedic Surgery Musculoskeletal surgeries to address alignment, contracture, and other lower-extremity impairments. This study does not impact surgical decision making but evaluates changes in gait before and after surgery. |
实验性Audiovisual + Sensorimotor Biofeedback Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving both audiovisual and sensorimotor biofeedback. Sensorimotor biofeedback will be provided with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait. The visual feedback will be provided on a screen with a bar showing real-time muscle activity and the audi...显示更多 | Biomotum Spark: Robotic ankle resistance Robotic ankle exoskeleton that provides resistance to ankle plantarflexion. Audiovisual Biofeedback Electromyography recordings from the plantarflexor muscles are used to provide audio feedback via a sound that plays when muscle activity is above target and a visual bar that displays real-time muscle activity. |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in Soleus Muscle Activity | Average stance-phase magnitude of soleus muscle activity from electromyography recording measured during gait at 1-month follow-up. | Change from baseline to intervention follow-up, assessed up to 18 months |
Change in Peak Ankle Power | Average peak ankle power evaluated during gait. | Change from baseline to intervention follow-up, assessed up to 18 months |
Change in Self-Selected Walking Speed | Average overground walking speed. | Change from baseline after intervention. |
Change in Dynamic Motor Control During Walking (Walk-DMC) | The total variance account for by one muscle synergy calculated from electromyography recordings during gait. | Change from baseline to intervention follow-up, assessed up to 18 months |
Change in Gait Deviation Index (GDI) | Deviation in gait kinematics compared to nondisabled gait. | Change from baseline to intervention follow-up, assessed up to 18 months |
Change in Gross Motor Function Measure - 66 (GMFM-66) Parts D & E | Assessment tool designed and evaluated to measure changes in gross motor function. Parts D \& E focus on standing, walking, jumping, and running function. | Change from baseline to intervention follow-up, assessed up to 18 months |
参与助手
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
7 Years
适龄性别
全部
接受健康志愿者
是
- Diagnosis of bilateral cerebral palsy that impacts both legs
- Gross Motor Functional Classification System Level II
- No surgery or lower-extremity injuries 12 months prior to enrollment
- No botulinum toxin injections in prior 3 months
- No prior selective dorsal rhizotomy surgery
- No history of seizures or cardiac conditions that would preclude walking on a treadmill for 20 minutes
- No current pain that hinders walking
华盛顿大学398 个活跃的临床试验可供探索研究责任方
Katherine Steele, 主要研究者, Professor, Mechanical Engineering, University of Washington
研究中心联系人
联系人: Katherine M Steele, PhD, 206-685-2390, [email protected]
联系人: Alyssa Spomer, PhD, [email protected]
1 位于 1 个国家/地区的研究中心
Minnesota
Gillette Children's, Saint Paul, Minnesota, 55101, United States
Alyssa Spomer, PhD, 联系人, 651-229-3904, [email protected]
Michael H Schwartz, PhD, 联系人, [email protected]
招募中