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Completed

NCT Number: NCT02603718

An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

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.

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Key information

Conditions

Stroke Rehabilitation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reuth Rehabilitation Hospital

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients after stroke willing

Exclusion criteria

Treatment and study plan

Rehabilitation treatment

Other

Primary outcomes

  1. Clinical outcome on a -3 to +3 scale

    Time frame: 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

  2. Mean brain engagement index during treatment.

    Time frame: 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

  3. Session effectiveness index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Reuth Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2015
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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