The Immediate Effect of Electrical Stimulation Transcranial Direct Current (tDCS) Associated With the Use of FES, in Muscle Activity of the Tibialis Anterior Muscle, Balance and Plantar Pressure Distribution of Individuals With Hemiparesis Due to Stroke

October 24, 2016 updated by: Aline Marina Alves Fruhauf, University of Nove de Julho

The Immediate Effect of Electrical Stimulation Transcranial Direct Current (tDCS) Associated With the Use of FES, in Muscle Activity of the Tibialis Anterior Muscle, Balance and Plantar Pressure Distribution of Individuals With Hemiparesis Due to Stroke - Randomized, Double Blind

Background: Transcranial direct current stimulation (tDCS) is currently considered a beneficial method for patients with neurological problems due to the modulation of cortex activity as well as the enhancement and prolongation of functional gains achieved during physical therapy. Purpose: The aim of the proposed study is to evaluate the immediate effects of a session of tDCS over the primary motor cortex combined with functional electrical simulation (FES) on electrical activity of the tibialis anterior muscle, balance and distribution of plantar pressure in individuals with hemiparesis stemming from a stroke. A further aim is to determine whether the effects of the combination of both stimulation methods are better than those achieved when each method is employed alone. Methods/design: A randomized, double-blind, crossover, cross-sectional study will be conducted involving 30 stroke survivors with hemiparesis who meet the eligibility criteria. Evaluations will involve an identification and screening chart, the classification of motor impairment using the Fugl-Meyer Scale, the determination of spasticity of the triceps surae muscle (modified Ashworth scale), electromyography of the tibialis anterior muscle, static balance and cognitive dual-task balance (stabilometry) and plantar pressure. After the initial evaluations, the participants will undergo four interventions: 1) anodal tDCS + placebo FES + active tibialis anterior contraction; 2) placebo tDCS + active FES + active tibialis anterior contraction; 3) anodal tDCS + active FES + active tibialis anterior contraction; and 4) placebo tDCS + placebo FES placebo + active tibialis anterior contraction. tDCS will be administered over the primary motor cortex and FES will be administered over the tibialis anterior muscle. The order of the different protocols will be randomized and both the evaluator and patients will be blinded to which protocol is being administered.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

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
    • SP
      • São Paulo, SP, Brazil
        • University Nove de Julho

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 30 individuals with hemiparesis stemming from a stroke;
  • Either gender;
  • Able to maintain a standing position without an assistance device for at least 60 seconds;
  • Signed statement of written consent.

Exclusion criteria:

  • Adverse health condition (beyond hemiparesis) that affects balance;
  • Use of medication that can affect balance;
  • Positive cutoff point for cognitive deficit (Mini Mental State Examination);
  • Illiteracy;
  • Wernicke's aphasia;
  • Reduced ankle mobility due to history of ankle fracture and use of pins in ankle;
  • TA muscle strength less than grade 1;
  • Contraindication for tDCS (history of recurrent seizures, recurrent epilepsy and brain tumor in stimulation site);
  • Skin infection at tDCS and/or FES site;
  • Anesthesia or hyperesthesia at FES site.

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1- tDCS 2--FES
  1. Transcranial stimulation ( tDCS ) will be administered using Tct Research 1 CH tdcs Simulator model 101. tDCS will be performed for 20 minutes and intensity 2mA associated active contraction of the TA muscle. Placebo tDCS will follow the same procedures as active tDCS with active, but the tDCS device will only be switched on for 20 seconds.
  2. Functional electrical stimulation (FES) will be administered using QUARK® FES VIF 995 DUAL device. The duration of active FES will be 20 minutes, associated with active contraction of the TA muscle. The pulse width will be 250 µs, modulated at a frequency of 50 Hz, with one to two stimulation cycles (6 seconds on and 12 seconds off) and the intensity will be increased until reaching the motor threshold. Placebo FES will follow the same procedures as active FES , but the FES device will only be switched on for 20 seconds, following which the intensity will be gradually reduced to 0 mA.
Device: Transcranial direct current stimulation (tDCS)
The active tDCS and placebo will be applied to the primary motor cortex (M1) and FES active and placebo will be applied to the anterior tibial muscle (TA).
Device: Functional electrical stimulation (FES)
Device: Sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
electromyography (EMG ) activity of Tibialis Anterior Muscle.
Time Frame: 1 years
1 years

Collaborators and Investigators

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

Sponsor

University of Nove de Julho

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

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

January 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/18128-6

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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