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An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

Primary Purpose

Stroke Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Rehabilitation treatment
Sponsored by
Reuth Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Rehabilitation focused on measuring Stroke, On-line EEG, BEI index, Attention, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients after stroke willing

Exclusion Criteria:

Sites / Locations

  • Reuth Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard physical therapy treatment with feedback

Standard physical therapy treatment without feedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical outcome on a -3 to +3 scale
video
Mean brain engagement index during treatment.
scale from zero to one, the time in which the measure excedes a predefined threshhold level during tretment
Session effectiveness index
Scale from 1 to 3, the average of effectiveness evaluations for all the treatments in each session was used as the session effectiveness index

Secondary Outcome Measures

Full Information

First Posted
October 14, 2015
Last Updated
September 12, 2019
Sponsor
Reuth Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02603718
Brief Title
An Applicative On-line EEG Tool for Enhancing Treatment Efficacy
Official Title
An Applicative On-line EEG Tool for Enhancing Treatment Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
August 28, 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reuth Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation
Keywords
Stroke, On-line EEG, BEI index, Attention, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard physical therapy treatment with feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard physical therapy treatment without feedback
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Rehabilitation treatment
Primary Outcome Measure Information:
Title
Clinical outcome on a -3 to +3 scale
Description
video
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.
Title
Mean brain engagement index during treatment.
Description
scale from zero to one, the time in which the measure excedes a predefined threshhold level during tretment
Time Frame
During the whole treatment session, each participant will be assessed twice within two weeks from recruitment to the study.
Title
Session effectiveness index
Description
Scale from 1 to 3, the average of effectiveness evaluations for all the treatments in each session was used as the session effectiveness index
Time Frame
Through treatment sessions, each participant will be assessed twice within two weeks from recruitment to the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients after stroke willing Exclusion Criteria:
Facility Information:
Facility Name
Reuth Rehabilitation Hospital
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
29147661
Citation
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.
Results Reference
derived

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An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

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