跳至主要内容
临床试验/NCT02603718
NCT02603718已完成不适用

An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

Reuth Rehabilitation Hospital1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Mean brain engagement index during treatment.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients after stroke willing

排除标准

  • 未提供

研究组 & 干预措施

Standard physical therapy treatment with feedback

Experimental

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.

干预措施: Rehabilitation treatment (Other)

Standard physical therapy treatment without feedback

Experimental

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.

干预措施: Rehabilitation treatment (Other)

结局指标

主要结局

Mean brain engagement index during treatment.

时间窗: During the whole treatment session, each participant will be assessed twice within two weeks from recruitment to the study.

scale from zero to one, the time in which the measure excedes a predefined threshhold level during tretment

Session effectiveness index

时间窗: Through treatment sessions, each participant will be assessed twice within two weeks from recruitment to the study.

Scale from 1 to 3, the average of effectiveness evaluations for all the treatments in each session was used as the session effectiveness index

Clinical outcome on a -3 to +3 scale

时间窗: 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.

video

次要结局

未报告次要终点

研究者

发起方
Reuth Rehabilitation Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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