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An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603718
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Reuth Rehabilitation Hospital

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE November 13, 2015
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE March 2014
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Applicative On-line EEG Tool for Enhancing Treatment Efficacy
Official Title  ICMJE An Applicative On-line EEG Tool for Enhancing Treatment Efficacy
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke Rehabilitation
Intervention  ICMJE Other: Rehabilitation treatment
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: Rehabilitation treatment
Publications * Bartur G, Joubran K, Peleg-Shani S, Vatine JJ, Shahaf G. An EEG Tool for Monitoring Patient Engagement during Stroke Rehabilitation: A Feasibility Study. Biomed Res Int. 2017;2017:9071568. doi: 10.1155/2017/9071568. Epub 2017 Sep 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2019)
37
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
80
Actual Study Completion Date  ICMJE August 28, 2017
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients after stroke willing

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02603718
Other Study ID Numbers  ICMJE 2014-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reuth Rehabilitation Hospital
Study Sponsor  ICMJE Reuth Rehabilitation Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Reuth Rehabilitation Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP