An Applicative On-line EEG Tool for Enhancing Treatment Efficacy
2019年9月12日 更新者:Reuth Rehabilitation Hospital
The purpose of this study is to investigate the efficacy of a simple and easy to use tool that can extract relevant attention-related markers - Brain Engagement Index (BEI) from ongoing EEG.
During standard rehabilitative physical therapy sessions.
研究概览
详细说明
This research aims at assessing and fine tuning the effectiveness of a unique tool for online guidance of neural rehabilitation.
The tool monitors patient attention level and guides the therapist online regarding the effectiveness of the current exercise employed.
It is well established that maintaining a high level of attention plays a major role in the clinical outcome in rehabilitation.
The monitoring is achieved using a cheap and simple to use EEG system and a breakthrough signal processing algorithm.
The feedback provides the caregiver and patient with online information regarding the effectiveness of attention recruited during a given exercise.
Furthermore, the investigators are developing and fine-tuning a set of guidelines to attain optimal attention levels.
These guide lines include : Choosing an appropriate goal/movement for each patient; Regulating the optimal degree of effort by changing the difficulty level of the exercise, changing the exercise or suggesting a short rest period; Integrating supportive exercises such as stretches, strengthening of stabilizers normalization of muscle tone, sensory stimulation etc. which may enhance the performance of the target goal/movement; Motivating patients to exert more effort; And taking advantage of the quality control aspect of the BEI index in-order to augment attention of both therapist and patient.
研究类型
介入性
注册 (实际的)
37
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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Tel Aviv、以色列
- Reuth Rehabilitation Hospital
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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
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients after stroke willing
Exclusion Criteria:
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:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Standard physical therapy treatment with feedback
Standard physical therapy rehabilitation is administered to stroke patients.
Attention level of the patient gathered with an EEG tool is measured, and provided to both therapist and patient on-line during one of the two treatments.
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实验性的:Standard physical therapy treatment without feedback
Standard physical therapy rehabilitation is administered to stroke patients.
Attention level of the patient gathered with an EEG tool is measured but feedback is not provided.
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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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Clinical outcome on a -3 to +3 scale
大体时间:Change in performance between pre & post treatment, will be assessed twice, in the feedback session and non-feedback session. Each participant will be assessed twice within two weeks from recruitment to the study.
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video
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Change in performance between pre & post treatment, will be assessed twice, in the feedback session and non-feedback session. Each participant will be assessed twice within two weeks from recruitment to the study.
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Mean brain engagement index during treatment.
大体时间:During the whole treatment session, each participant will be assessed twice within two weeks from recruitment to the study.
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scale from zero to one, the time in which the measure excedes a predefined threshhold level during tretment
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During the whole treatment session, each participant will be assessed twice within two weeks from recruitment to the study.
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Session effectiveness index
大体时间:Through treatment sessions, each participant will be assessed twice within two weeks from recruitment to the study.
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Scale from 1 to 3, the average of effectiveness evaluations for all the treatments in each session was used as the session effectiveness index
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Through treatment sessions, each participant will be assessed twice within two weeks from recruitment to the study.
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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。
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)
2014年3月1日
初级完成 (实际的)
2017年8月28日
研究完成 (实际的)
2017年8月28日
研究注册日期
首次提交
2015年10月14日
首先提交符合 QC 标准的
2015年11月10日
首次发布 (估计)
2015年11月13日
研究记录更新
最后更新发布 (实际的)
2019年9月13日
上次提交的符合 QC 标准的更新
2019年9月12日
最后验证
2018年5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.