Evaluation of Electrical Activity Tibial Muscle and Postural Control of Individuals With Hemiparesia Post TDCS Associated With FES

Hemiparesis Clinical Trial

Official title:

EVALUATION OF ELECTRICAL ACTIVITY TIBIAL MUSCLE AND POSTURAL CONTROL OF INDIVIDUALS WITH HEMIPARESIA FROM AVE SUBMITTED TDCS ASSOCIATED WITH FES - CLINICAL STUDY, RANDOMIZED, DOUBLE BLIND.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03008720
• Other study ID #: 767.866
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 28, 2016
• Last updated: January 1, 2017
• Start date: February 2017
• Est. completion date: November 2018

Study information

• Verified date: January 2017
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Health authority: BRAZIL: University Nove de Julho
• Study type: Interventional

Clinical Trial Summary

Introduction: It is suggested that increased cortical activity, induced by cerebral stimulation associated or not with other rehabilitation techniques, may potentiate the motor and functional therapeutic effects in individuals with neurological deficits. Objectives: To evaluate the electrical activity of the anterior tibial muscle (TA) and postural control of individuals with hemiparesis due to stroke following treatment with transcranial direct current (tDCS) stimulation and functional electrical stimulation (FES), associated or isolated). (EMG) and postural control by the Balance Evaluation Systems Test (BESTest). Both of which were collected at four different time points: pre-treatment, immediately after 10 treatment sessions, and 30 days follow-up after the interventions. Patients will be randomized into 4 experimental groups: tDCS anodic active + active FES+ active contraction TA, tDCS sham + active FES+ active contraction TA, tDCS anodic active+ placebo FES+ active contraction TA, tDCS sham+ FES sham+ active contraction TA. tDCS (2mA) will be applied over the motor (Cz) and cathodic vertex over the supraorbital region of the normal hemisphere and FES over hemiparetic TA by a researcher who will not be the one who will evaluate the anesthesia patient. The treatment will last 10 sessions, twice a week, with a time of 20 minutes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

Inclusion criteria:

• Individuals with hemiparesis due to stroke;

• Both sexes;

• Agree to sign the free and informed consent form.

Exclusion criteria:

• Positive cut-off point for the Mini Mental State Examination (MMSE) of less than 11 points already corrected for schooling;

• Ankle mobility reduced by history of fracture or use of ankle fasteners;

• Irreducible equine deformity;

• Muscle strength level of AT less than 1 by the scale of Kendall;

• Patients with reported severe visual impairment;

• Contraindications to the use of transcranial direct current stimulation (history of seizure or recurrent epilepsy, brain tumors at the stimulation site, metallic materials implanted in the brain);

• Individuals with cutaneous infection at the point of application of FECC or FES;

• Individuals who presented anesthesia or hyperesthesia at the point of application of the ECTS;

• Individuals diagnosed with deep venous thrombosis (DVT);

• Individuals diagnosed with degenerative diseases or polyneuropathies.

• Individuals who do not present complementary tests that diagnose the lesion site.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Electromyography
• Hemiparesis
• Paresis
• Transcranial Direct Current Stimulation

Intervention

Device:
• Transcranial direct current stimulation (tDCS)

• Functional electrical stimulation (FES)

• Sham stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle		1 YEAR	No