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

Primary Purpose

Hemiparesis, Transcranial Direct Current Stimulation, Electromyography

Status
Unknown status
Phase
Phase 2
Locations
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 Hemiparesis focused on measuring functional electrical simulation

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    tDCS active

    tDCS sham

    FES active

    FES sham

    Arm Description

    Transcranial stimulation ( tDCS ) active 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) active 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

    electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle

    Secondary Outcome Measures

    Full Information

    First Posted
    December 28, 2016
    Last Updated
    January 1, 2017
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03008720
    Brief Title
    Evaluation of Electrical Activity Tibial Muscle and Postural Control of Individuals With Hemiparesia Post TDCS Associated With FES
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    November 2017 (Anticipated)
    Study Completion Date
    November 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiparesis, Transcranial Direct Current Stimulation, Electromyography
    Keywords
    functional electrical simulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    2 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tDCS active
    Arm Type
    Active Comparator
    Arm Description
    Transcranial stimulation ( tDCS ) active 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.
    Arm Title
    tDCS sham
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tDCS will follow the same procedures as active tDCS with active, but the tDCS device will only be switched on for 20 seconds.
    Arm Title
    FES active
    Arm Type
    Active Comparator
    Arm Description
    Functional electrical stimulation (FES) active 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.
    Arm Title
    FES sham
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Device
    Intervention Name(s)
    Functional electrical stimulation (FES)
    Intervention Type
    Device
    Intervention Name(s)
    Sham stimulation
    Primary Outcome Measure Information:
    Title
    electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle
    Time Frame
    1 YEAR

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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