Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Relief band (Somatosensory stimulation)
Placebo stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- University of São Paulo/General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Somatosensory stimulation
Control group
Arm Description
Active group
Placebo stimulation
Outcomes
Primary Outcome Measures
the improvement in upper extremity performance assessed using Jebsen-Taylor test
Secondary Outcome Measures
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients
Adverse events
Full Information
NCT ID
NCT01034150
First Posted
December 11, 2009
Last Updated
December 16, 2009
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT01034150
Brief Title
Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
Official Title
Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Somatosensory stimulation
Arm Type
Active Comparator
Arm Description
Active group
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo stimulation
Intervention Type
Device
Intervention Name(s)
Relief band (Somatosensory stimulation)
Other Intervention Name(s)
Relief band
Intervention Description
Electrical median nerve stimulation
Intervention Type
Device
Intervention Name(s)
Placebo stimulation
Other Intervention Name(s)
no stimulation
Intervention Description
Placebo stimulation
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients
Time Frame
immediately after the treatment
Title
Adverse events
Time Frame
at end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Conforto, MD PhD
Organizational Affiliation
Hospital das Clínicas/FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo/General Hospital
City
São Paulo
State/Province
SP
ZIP/Postal Code
55
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
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