试验雷达 AI | ||
|---|---|---|
临床试验 NCT07506837 (UEM-HABITILE) 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。 | ||
一个试验符合筛选条件
卡片视图
Effects of an HABIT-ILE-Based Intervention in Children With Cerebral Palsy (UEM-HABITILE) 30 创新疗法 预防
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07506837 (UEM-HABITILE)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2027年3月1日开始，预计招募30名患者。该研究由Universidad Europea de Madrid主导，计划于2028年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年4月2日。
简要概括
This interventional study will evaluate the effects of an intensive HABIT-ILE-based camp on cardiorespiratory measures and body composition in children with cerebral palsy. Although intensive motor control-based therapies such as HABIT/HABIT-ILE have shown functional benefits, the novelty of this study is the assessment of energy expenditure during functional tasks and post-intervention changes in body composition. P...显示更多
详细描述
Children with cerebral palsy frequently present limitations in upper and lower extremity function that affect mobility, daily activities, and participation. Intensive motor control-based approaches, particularly Hand-Arm Bimanual Intensive Therapy (HABIT) and Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE), have shown functional benefits in this population. In prior HABIT/HABIT-ILE programs,...显示更多
官方标题
Effects of Intensive Motor Control-Based Therapy for Upper and Lower Extremities in 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
- UEM-HABITILE
- UEM-HABITILE-CAMP
NCT编号
实际开始日期
2027-03-01
最近更新发布
2026-04-02
预计完成日期
2028-01-01
计划入组人数
30
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
Cerebral Palsy
HABIT-ILE
Body Composition
Energy Expenditure
HABIT-ILE
Body Composition
Energy Expenditure
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
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Cerebral palsy HABIT-ILE Intensive therapy Pediatric rehabilitation Bimanual training Functional mob Children with cerebral palsy will participate in a summer camp-format intensive rehabilitation program based on HABIT-ILE principles. The intervention includes upper and lower extremity motor training delivered in a playful, progressive group setting by trained interventionists under professional supervision. The program is administered over 15 days, 6 hours/day (90 total hours), with activities adapted to participan...显示更多 | HABIT-ILE Participants will receive a 90-hour intensive intervention (6 hours/day for 15 days) in a summer camp format. The intervention includes bimanual upper-limb activities; lower-extremity and mobility training (e.g., walking on different surfaces, treadmill walking, stair negotiation); activity-based strengthening; and whole-body playful activities (e.g., dance and sports games). New technologies (e.g., videogame-based a...显示更多 |
无干预Wait-List Control Children with cerebral palsy assigned to the wait-list control group will not receive the intensive HABIT-ILE-based summer camp intervention during the initial study comparison period. They will continue with their usual care and will be offered participation in the camp intervention next year, according to program availability and study logistics. | 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 |
|---|---|---|
Change in task-related energy expenditure during low-intensity functional activity | Change in energy expenditure during low-intensity functional tasks (e.g., comfortable walking), assessed in the physiology laboratory using gas analysis and electrocardiographic monitoring during task performance. | Baseline, 15 days after, 6 months after |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in body composition | Change in body composition assessed using DEXA at Universidad Europea de Madrid. | Baseline, 15 days after and 6 months after |
Change in manual function (Assisting Hand Assessment, AHA) | Change in effectiveness of use of the affected hand during bimanual performance, assessed with the Assisting Hand Assessment (AHA). | Baseline, 15 days after and 6 months after |
Change in unilateral hand function performance (Jebsen-Taylor Test of Hand Function) | Change in unilateral hand function performance, assessed by time to complete standardized manual tasks using the Jebsen-Taylor Test of Hand Function | Baseline, 15 days after, 6 months after |
Change in walking capacity (6-Minute Walk Test) | Change in unilateral hand function performance, assessed by time to complete standardized manual tasks using the Jebsen-Taylor Test of Hand Function | Baseline, 15 days after and 6 months after |
Change in gait speed (10-Meter Walk Test) | Change in gait speed, assessed by time required to walk 10 meters during the 10-Meter | Baseline, 15 days after and 6 months after |
Change in functional mobility (Timed Up and Go) | Change in functional mobility, assessed by the Timed Up and Go test (time required to stand up, walk, turn, return, and sit down) | Baseline, 15 days after, 6 months after |
Change in gross motor function (GMFM) | Change in gross motor function (GMFM) | Baselilne, 15 days after, 6 months after |
Change in functional balance (Pediatric Balance Scale) | Change in functional balance (Pediatric Balance Scale) | Baseline, 15 days after and 1 month after |
Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM) | Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM) | Baseline, 15 days after, 6 months after |
Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI) | Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI) | Baseline, 15 days after, 6 months after |
Change in parent-reported manual ability ABILHAND-Kids) | Change in parent-reported manual ability (ABILHAND-Kids ) | Baseline, 15 days after and 6 months after |
Change in parent-reported locomotion difficulty (ABILOCO-Kids) | Change in parent-reported locomotion difficulty (ABILOCO-Kids) | Baseline, 15 days after and 6 months after |
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
- Children with a diagnosis of cerebral palsy (hemiparesis or diparesis).
- Age 6 to 13 years.
- Moderate cognitive impairment or cognitive status compatible with the ability to follow verbal instructions.
- Ability to participate in an intensive summer camp-format rehabilitation program.
- Parent/legal guardian able to provide informed consent and complete parent-/tutor-reported outcome measures.
- Medical or orthopedic condition that contraindicates participation in intensive physical rehabilitation activities.
- Unstable neurological or medical condition (e.g., uncontrolled seizures) that may interfere with safe participation.
- Severe cognitive or behavioral impairment preventing comprehension of basic verbal instructions or safe participation in group activities.
- Contraindication to study assessment procedures, including physiological testing or DEXA body composition assessment.
- Participation in another concurrent intensive rehabilitation program during the study comparison period.
- Any condition that, in the investigators' judgment, may compromise safety, adherence, or outcome assessment validity.
Universidad Europea de Madrid研究责任方
Vanesa Abuín, 主要研究者, Associate Professor, Universidad Europea de Madrid
研究中心联系人
联系人: Vanesa Abuín, (+34) 912 115 224, [email protected]
没有位置数据。