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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

Primary Purpose

STROKE

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Functional electrical stimulation (FES)
Sham stimulation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STROKE focused on measuring Transcranial direct current stimulation, functional electrical stimulation, hemiparesis, electromyography, balance

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Nove de Julho

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1- tDCS 2--FES

Arm Description

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. 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.

Outcomes

Primary Outcome Measures

electromyography (EMG ) activity of Tibialis Anterior Muscle.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2015
Last Updated
October 24, 2016
Sponsor
University of Nove de Julho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02389608
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STROKE
Keywords
Transcranial direct current stimulation, functional electrical stimulation, hemiparesis, electromyography, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1- tDCS 2--FES
Arm Type
Experimental
Arm Description
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. 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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Functional electrical stimulation (FES)
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Primary Outcome Measure Information:
Title
electromyography (EMG ) activity of Tibialis Anterior Muscle.
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Nove de Julho
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived

Learn more about this trial

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

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