An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

NCT02603718 | Completed DMC

• 1 other identifier: 2014-3
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Rehabilitation

Keywords

Stroke; On-line EEG; BEI index; Attention; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Clinical outcome on a -3 to +3 scale

  video

  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.

• Mean brain engagement index during treatment.

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

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

• 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

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

Study Arms (2)

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.

Other: Rehabilitation treatment

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.

Other: Rehabilitation treatment

Interventions

Rehabilitation treatment OTHER

Standard physical therapy treatment with feedback; Standard physical therapy treatment without feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients after stroke willing

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, Israel

Location

Related Publications (1)

• 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.

  PMID: 29147661 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: November 13, 2015
• Study Start: March 1, 2014
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: September 13, 2019

Record last verified: 2018-05

Locations

IL (1)