Association Between the tDCS and FDS for Gait Rehabilitation After Stroke

NCT ID: NCT04077814

Last Updated: 2021-02-11

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2020-09-30

Brief Summary

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The aim of this study is to verify the effectiveness of tDCS combined with foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate compromise.

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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ShamtDCS+FDS

Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Sham Transcranial direct brain stimulation (tDCS)

Group Type ACTIVE_COMPARATOR

Foot Drop Stimulatio - Neuro Orthosis

Intervention Type DEVICE

Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.

tDCS+FDS

Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Transcranial direct brain stimulation (tDCS)

Group Type EXPERIMENTAL

Foot Drop Stimulatio - Neuro Orthosis

Intervention Type DEVICE

Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.

Transcranial direct brain stimulation

Intervention Type DEVICE

Transcranial direct brain stimulation on motor cortex

Interventions

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Foot Drop Stimulatio - Neuro Orthosis

Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.

Intervention Type DEVICE

Transcranial direct brain stimulation

Transcranial direct brain stimulation on motor cortex

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects with ischemic or hemorrhagic stroke diagnosis.
* Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months)
* Minimal cognitive ability to understand commands
* Able to walk 10 meters unassisted or with minimal assistance

Exclusion Criteria

* No current use of antiepileptic drugs for seizures
* Secondary musculoskeletal disorder involving the lower limb
* Contraindication for electrical stimulation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Aline de Souza Pagnussat

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aline S Pagnussat, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Sciences of Porto Alegre

Locations

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Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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da Cunha MJ, Pinto C, Schifino GP, Sant'Anna Py I, Cimolin V, Pagnussat AS. Bicephalic Transcranial Direct-Current Stimulation Does Not Add Benefits to a Footdrop Stimulator for Improving Functional Mobility in People With Chronic Hemiparesis After Stroke: A Double-Blind, Randomized Controlled Trial. Phys Ther. 2022 Aug 4;102(8):pzac079. doi: 10.1093/ptj/pzac079.

Reference Type DERIVED
PMID: 35689805 (View on PubMed)

Other Identifiers

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tDCS_FDS_2018

Identifier Type: -

Identifier Source: org_study_id

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