TRANSSPINAL DIRECT CURRENT STIMULATION ON FUNCTIONAL MOBILITY IN POST-STROKE PATIENTS

NCT ID: NCT06724367

Last Updated: 2024-12-09

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2026-03-31

Brief Summary

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The aim of this clinical trial is to investigate the effects of transspinal direct current stimulation on the functional mobility of post-stroke patients.

The main question it aims to answer is:

Is transspinal direct current stimulation able to improve functional mobility in post-stroke patients?

The researchers will compare transspinal direct current stimulation associated with gait training with sham transspinal direct current stimulation associated with gait training. To verify the effects of stimulation on the functional mobility of post-stroke patients.

Participants:

* They will be assessed before starting the care, after the care has been completed, 15 and 30 days after the care has been completed.
* They will take part in 10 sessions of transspinal direct current stimulation associated with gait training.

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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Transspinal direct current stimulation

This group will receive 10 sessions of transspinal direct current stimulation associated with gait training.

Group Type EXPERIMENTAL

Transspinal direct current stimulation

Intervention Type DEVICE

Direct current electrical stimulation applied non-invasively to the spinal cord.

Transspinal direct current stimulation sham

This group will receive 10 sessions of sham transspinal direct current stimulation associated with gait training.

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type DEVICE

transspinal direct current stimulation simulated

Interventions

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Transspinal direct current stimulation

Direct current electrical stimulation applied non-invasively to the spinal cord.

Intervention Type DEVICE

Sham Comparator

transspinal direct current stimulation simulated

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of ischemic or hemorrhagic stroke, provided by a neurologist.
* Age group greater than or equal to 18 years, of both sexes.
* Any stage of the disease.
* Presence of lower limb sensorimotor disorder related to the stroke
* Absence of cognitive impairment verified through the Mini Mental State Examination (score ≥ 18 for illiterate individuals and ≥ 24 for educated individuals) modified for the Brazilian population.

Exclusion Criteria

* With other neurological injuries
* With vestibular, visual, cardiovascular or osteomyoarticular disorders of the lower limb that may affect the performance of the proposed tests
* Who have a pacemaker or metallic implants in their spine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Kátia Monte-Silva

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Kátia Monte-Silva

Role: CONTACT

Phone: +55 81 9988631322

Email: [email protected]

Other Identifiers

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81604324.2.0000.5208

Identifier Type: -

Identifier Source: org_study_id