Intensive Goal Training for Adolescents With Cerebral Palsy
2019年2月12日 更新者：MARINA B BRANDAO、Federal University of Minas Gerais
Intensive Training of Functional Priorities Reported by Adolescents With Cerebral Palsy
Adolescents with cerebral palsy (CP) present important limitations for the performance of daily living activities.
The aims of the study is to evaluate the feasibility and effects of an intensive goal training protocol for adolescents with CP.
He hypothesize that adolescents submitted to the studied protocol will present improvements in performance and satisfaction of prioritized functional goals.
研究概览
详细说明
We will conduct a feasibility study to assess the implementation and the possible effects of an intensive individualized goal training with adolescents with CP.
Adolescents will select up to 5 functional goals to be trained during a 2 weeks, 3 hour-daily training, totalling 30 hours across 2 weeks.
Moreover, they will be asked to daily practice these activities at home along the intervention period.
研究类型
介入性
注册 (预期的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Minas Gerais
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Belo Horizonte、Minas Gerais、巴西
- 招聘中
- Associação Mineira de Reabilitação
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接触：
- Priscilla B Figueiredo
- 电话号码：3198839646
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 13年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Medical diagnosis of bilateral CP;
- Age between 12 and 17 years old;
- Manual Ability Classification System (MACS) ranging from levels I to III;
- Gross Motor Function Classification System (GMFCS) ranging from levels I to IV;
- Ability to understand verbal instructions.
Exclusion Criteria:
- Botulinum toxin or surgery in upper limbs in the previous 6 months of the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention group
Intensive goal training of relevant activities reported by adolescents in the beginning of the study.
Therapists will grade the level of complexity of the proposed activities, considering the relevant movements, task demands and contextual factors involved in the performance of each task.
Adolescents will be asked to practice these activities at home (1 hour/daily) and to discuss their difficulties and improvements with the therapists.
The intervention will be provided in a day-camp model.
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Intensive goal training : 30 hours during 2 weeks
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Functional Goals
大体时间：1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Canadian Occupational Performance Measure (COPM) (ranging 1-10; higher values, better outcomes)
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Change in Daily functioning- Self-Care
大体时间：1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Pediatric Evaluation Disability Inventory (PEDI) self-care: ranging from 0-63; higher values, better outcomes
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Change in Daily functioning- Mobility
大体时间：1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Pediatric Evaluation Disability Inventory (PEDI) mobility: ranging from 0-55; higher values, better outcomes
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Manual dexterity
大体时间：1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Box & Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
|
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Change in Gross motor function
大体时间：1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Gross Motor Function Measure (GMFM): gross motor function abilities assessed in activities from 5 domains: lying and rolling; seating; crawling and kneeling; standing; walking, running and jumping.
higher scores, better outcome
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Change in Participation at home
大体时间：1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Participation Environment Measure: Children and Youth (PEM-CY): Structured questionnaire to assess the frequency and level of involvement in daily living tasks (home scale will be used) higher scores, better outcomes
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Change in Participation in household activities
大体时间：1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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Children´s Helping Out: Responsibility, Expectations and Supports (CHORES): structured questionnaire to assess the frequency and level of assistance in household activities: higher scores, better outcomes
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1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.
- de Brito Brandao M, Gordon AM, Mancini MC. Functional impact of constraint therapy and bimanual training in children with cerebral palsy: a randomized controlled trial. Am J Occup Ther. 2012 Nov-Dec;66(6):672-81. doi: 10.5014/ajot.2012.004622.
- Bleyenheuft Y, Ebner-Karestinos D, Surana B, Paradis J, Sidiropoulos A, Renders A, Friel KM, Brandao M, Rameckers E, Gordon AM. Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Dev Med Child Neurol. 2017 Jun;59(6):625-633. doi: 10.1111/dmcn.13379. Epub 2017 Jan 30.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年6月2日
初级完成 (预期的)
2019年6月30日
研究完成 (预期的)
2019年6月30日
研究注册日期
首次提交
2018年4月26日
首先提交符合 QC 标准的
2018年5月8日
首次发布 (实际的)
2018年5月21日
研究记录更新
最后更新发布 (实际的)
2019年2月15日
上次提交的符合 QC 标准的更新
2019年2月12日
最后验证
2019年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.