Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb Rehabilitation After Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2019-01-15

Brief Summary

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The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb rehabilitation of post-stroke subjects with moderate and severe compromise.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Functional electrical stimulation (FES)

Chronic stroke patients submitted to functional electrical stimulation (FES).

Group Type ACTIVE_COMPARATOR

Functional Electrical Stimulation (FES)

Intervention Type DEVICE

Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)

Combination of transcranial direct current stimulation and FES

Chronic stroke patients submitted to transcranial direct current stimulation (tDCS) and functional and to functional electrical stimulation (FES).

Group Type EXPERIMENTAL

Combination of Transcranial direct brain stimulation (tDCS) and FES

Intervention Type DEVICE

Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)

Interventions

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Functional Electrical Stimulation (FES)

Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)

Intervention Type DEVICE

Combination of Transcranial direct brain stimulation (tDCS) and FES

Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects with ischemic or hemorrhagic stroke diagnosis and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease)
* Ability to reach 60 degrees in the shoulder flexion
* Minimal cognitive ability to understand commands
* No current use of antiepileptic drugs for seizures

Exclusion Criteria

* Painful shoulder, adhesive capsulitis or glenohumeral subluxation
* Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes