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临床试验 NCT06455930 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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Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy 早期I期 10
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临床试验NCT06455930旨在研究治疗，主要针对脑瘫。这是一项早期I期 干预性研究试验，目前试验状态为招募中。试验始于2024年6月1日，计划招募10名患者。该研究由University of North Florida主导，预计于2026年7月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年6月12日。
简要概括
The goal of this interventional study is to learn about the biomechanical factors underlying the beneficial changes in children with cerebral palsy after using individually-adapted stand-on ride-on power mobility devices (PMD).
The main questions we aim to answer are:
- How does the use of stand-on PMDs affect static balance in children with cerebral palsy?
- How does the use of stand-on PMDs affect dynamic balance...
官方标题
Biomechanical Changes Underpinning Stand-on Ride-on Power Mobility Devices for Children With 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
- UNFlorida
NCT编号
实际开始日期
2024-06-01
最近更新发布
2024-06-12
预计完成日期
2026-07-31
计划入组人数
10
研究类型
干预性研究
试验分期 (阶段)
早期I期
试验状态
招募中
关键词
Cerebral Palsy
Power Mobility Device
Balance
Muscle activity
Mobility
Power Mobility Device
Balance
Muscle activity
Mobility
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
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 |
|---|---|
不适用 | Stand-on ride-on power mobility device Children will receive the adapted toy car (individually-adapted stand-on PMD) to take home and use for three months. PMD will be used at their house and familiar environments to the family (e.g., neighborhood, parks, schools). |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Center of pressure sway area, standing | Measure of balance control during independent standing | Baseline, Pre (3 months post Baseline), Post (3 months post Pre) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Thigh muscle co-contraction (quadriceps:biceps femoris) | Agonist-antagonist muscle efficiency during functional tasks (e.g., sit-to-stand, independent static standing). | Baseline, Pre (3 months post Baseline), Post (3 months post Pre) |
Center of pressure sway area, sit-to-stand | Measure of dynamic balance control during sit-to-stand | Baseline, Pre (3 months post Baseline), Post (3 months post Pre) |
Trunk-pelvis coupling | Quantification of timing and magnitude of whole-body motor control coordination during functional tasks (e.g., sit-to-stand, walking turns). | Baseline, Pre (3 months post Baseline), Post (3 months post Pre) |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
4 Years
适龄性别
全部
- Diagnosis of spastic diplegia CP, GMFCS level III;
- Between 4 and 6 years old (age band selected based on the benefits of early intervention and the age-limitation imposed from the size constraints of the PMDs (toy cars) selected for the intervention);
- Able to stand and to walk short distances (at least 10 meters) with or without external assistance;
- Physician medical clearance to participate; and
- Exhibit sufficient cooperation and attention so that simple verbal instructions can be followed.
- Have notable orthopedic conditions (e.g., lower extremity amputation; recent hip surgeries or soft tissue lengthening);
- Inadequate vision to complete study's procedures safely;
- Serious/unstable cardiac conditions that prevent engagement in the Evaluation Sessions; and
- Any other factor that might hinder full participation in the study or confound interpretation of the results.
University of North FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)研究责任方
Guilherme Cesar, 主要研究者, Assistant Professor, University of North Florida
研究中心联系人
联系人: Guilherme M Cesar, PhD, PT, 904.620-2664, [email protected]
1 位于 1 个国家/地区的研究中心
Florida
University of North Florida, Jacksonville, Florida, 32224, United States
Guilherme M Cesar, PhD, PT, 联系人, 904-620-2664, [email protected]
Juan Aceros, PhD, 联系人, 904.620-1684, [email protected]
招募中