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Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients

NCT ID: NCT01034150

Last Updated: 2009-12-17

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

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-11-30

Brief Summary

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Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke.

Detailed Description

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Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (\> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.

Main measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Somatosensory stimulation

Active group

Group Type ACTIVE_COMPARATOR

Relief band (Somatosensory stimulation)

Intervention Type DEVICE

Electrical median nerve stimulation

Control group

Placebo stimulation

Group Type PLACEBO_COMPARATOR

Placebo stimulation

Intervention Type DEVICE

Placebo stimulation

Interventions

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Relief band (Somatosensory stimulation)

Electrical median nerve stimulation

Intervention Type DEVICE

Placebo stimulation

Placebo stimulation

Intervention Type DEVICE

Other Intervention Names

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Relief band no stimulation

Eligibility Criteria

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Inclusion Criteria

* age 18-80 years;
* single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);
* stroke onset at least six months before;
* hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).

Exclusion Criteria

* previous strokes;
* epilepsy and other neurological conditions;
* proprioceptive or tactile anesthesia;
* shoulder or hand pain;
* severe joint deformity;
* severe chronic disease;
* inability to give provide informed consent due to severe aphasia or cognitive impairment;
* left handedness before the stroke.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hospital das Clinicas/University of Sao Paulo

Principal Investigators

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Adriana Conforto, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clínicas/FMUSP

Locations

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University of São Paulo/General Hospital

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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477916/06-6

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1309-06

Identifier Type: -

Identifier Source: org_study_id