Skip to main content
OpenTrials
Completed

NCT Number: NCT02389608

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Nove de Julho

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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).

Functional Electrical Stimulation (FES)

Device

Sham stimulation

Device

Primary outcomes

  1. electromyography (EMG ) activity of Tibialis Anterior Muscle.

    Time frame: 1 years

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.