Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
2 other identifiers
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 stroke
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 11, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedDecember 17, 2009
November 1, 2009
1.8 years
December 11, 2009
December 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
the improvement in upper extremity performance assessed using Jebsen-Taylor test
Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment
Secondary Outcomes (2)
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients
immediately after the treatment
Adverse events
at end of treatment
Study Arms (2)
Somatosensory stimulation
ACTIVE COMPARATORActive group
Control group
PLACEBO COMPARATORPlacebo stimulation
Interventions
Electrical median nerve stimulation
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of São Paulo/General Hospital
São Paulo, São Paulo, 55, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriana Conforto, MD PhD
Hospital das Clínicas/FMUSP
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 11, 2009
First Posted
December 17, 2009
Study Start
December 1, 2007
Primary Completion
September 1, 2009
Study Completion
November 1, 2009
Last Updated
December 17, 2009
Record last verified: 2009-11