Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-28 @ 8:19 AM
Study NCT ID:
NCT01034150
Status:
COMPLETED
Last Update Posted:
2009-12-17
First Post:
2009-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 477916/06-6 | OTHER_GRANT | CNPq | View |