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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01034150 |
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Date of registration:
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11/12/2009 |
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Primary sponsor: |
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Public title:
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Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
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Scientific title:
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Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01034150 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Adriana Conforto, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital das Clínicas/FMUSP |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Device: Placebo stimulation
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Device: Relief band (Somatosensory stimulation)
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Primary Outcome(s)
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the improvement in upper extremity performance assessed using Jebsen-Taylor test
[Time Frame: Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment]
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Secondary Outcome(s)
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Adverse events
[Time Frame: at end of treatment]
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Compliance with the interventions, assessed through a daily written log, and oral reports of the patients
[Time Frame: immediately after the treatment]
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Secondary ID(s)
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1309-06
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477916/06-6
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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