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An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

This study is currently recruiting participants.
Verified November 2015 by Reuth Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02603718
First Posted: November 13, 2015
Last Update Posted: November 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Reuth Medical Center
  Purpose
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.

Condition Intervention
Stroke Rehabilitation Other: Rehabilitation treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

Resource links provided by NLM:


Further study details as provided by Reuth Medical Center:

Primary Outcome Measures:
  • 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

  • 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

  • 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


Estimated Enrollment: 80
Study Start Date: March 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Rehabilitation treatment
Experimental: 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.
Other: Rehabilitation treatment

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients after stroke willing

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603718


Contacts
Contact: Gadi Bartur, M.Sc. PT +972544798941 bargad@hotmail.com

Locations
Israel
Reuth Medical Center Recruiting
Tel Aviv, Israel
Contact: Gadi Bartur, M.Sc. PT    +972544798941    bargad@hotmail.com   
Reuth Rehabilitation Hospital Recruiting
Tel Aviv, Israel
Contact: Gadi Bartur, M.Sc. PT    +972544798941    bargad@hotmail.com   
Sub-Investigator: Gadi Bartur, M.Sc.PT         
Sponsors and Collaborators
Reuth Medical Center
  More Information

Responsible Party: Reuth Medical Center
ClinicalTrials.gov Identifier: NCT02603718     History of Changes
Other Study ID Numbers: 2014-3
First Submitted: October 14, 2015
First Posted: November 13, 2015
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by Reuth Medical Center:
Stroke
On-line EEG
BEI index
Attention
Rehabilitation