Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb Rehabilitation After Stroke

June 12, 2019 updated by: Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre

Association Between the Transcranial Direct Current Stimulation (tDCS) and Functional Electrical Stimulation (FES) for Upper-limb Rehabilitation After Stroke - A Randomized Clinical Trial

The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb rehabilitation of post-stroke subjects with moderate and severe compromise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Federal University of Health Sciences of Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with ischemic or hemorrhagic stroke diagnosis and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease)
  • Ability to reach 60 degrees in the shoulder flexion
  • Minimal cognitive ability to understand commands
  • No current use of antiepileptic drugs for seizures

Exclusion Criteria:

  • Painful shoulder, adhesive capsulitis or glenohumeral subluxation
  • Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Functional electrical stimulation (FES)
Chronic stroke patients submitted to functional electrical stimulation (FES).
Device: Functional Electrical Stimulation (FES)
Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)
Experimental: Combination of transcranial direct current stimulation and FES
Chronic stroke patients submitted to transcranial direct current stimulation (tDCS) and functional and to functional electrical stimulation (FES).
Device: Combination of Transcranial direct brain stimulation (tDCS) and FES
Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
Time Frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
3-D motion analysis system
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip force assessed by means of dynamometer
Time Frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Evaluated by means of dynamometer (Jamar)
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Manual dexterity assessed by means of the block and box test
Time Frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Block and box test
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)
Time Frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Questionnaire
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Muscular tone assessed by the Modified Ashworth Scale
Time Frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Modified Ashworth Scale
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale
Time Frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Fugl-Meyer scale
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2017

Primary Completion (Actual)

August 13, 2018

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APAPS2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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