Mobile Subthreshold Exercise Program for Concussion
赞助:
Seattle Children's Hospital
合作者:
信息的提供 (责任方):
Sara Chrisman,Seattle Children's Hospital
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 27, 2018 | ||
| 首次发布日期e ICMJE | October 1, 2018 | ||
| 最后更新发布日期 | October 1, 2018 | ||
| 预计研究开始日期 ICMJE | March 6, 2018 | ||
| 预计主要完成日期 | September 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Change in Health Behavior Inventory (HBI)[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ] Self-report questionnaire regarding concussive symptoms |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Mobile Subthreshold Exercise Program for Concussion | ||
| 正式标题 ICMJE | Mobile Subthreshold Exercise Program (M-STEP) for Concussion | ||
| 简要概况 | Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion. |
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| 详细说明 | 6-week pilot study of a novel intervention for concussion, administering a sub-threshold exercise program in a mobile fashion using video conferencing and providing feedback using wrist-worn accelerometry and heart rate monitoring. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: All youth will receive the intervention 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 1, 2019 | ||
| 预计主要完成日期 | September 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Concussion diagnosed by a healthcare provider that occurred 2 weeks-6 months ago - Continued symptoms with at least 3 symptoms on the HBI and a score of 20+ - No other issues that would preclude physical activity - Parents and youth are English-speaking Exclusion Criteria: - Already participating in >30 minutes of MVPA/day | ||
| 性别 |
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| 年龄 | 最小年龄:9 Years ,最大年龄:18 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Sara Chrisman,Seattle Children's Hospital | ||
| 研究赞助商 ICMJE | Seattle Children's Hospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Seattle Children's Hospital | ||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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