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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034150
• Other study ID #: 1309-06
• Secondary ID: 477916/06-6
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 11, 2009
• Last updated: December 16, 2009
• Start date: December 2007
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Relief band (Somatosensory stimulation)
Electrical median nerve stimulation
• Placebo stimulation
Placebo stimulation

Locations

Country	Name	City	State
Brazil	University of São Paulo/General Hospital	São Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Compliance with the interventions, assessed through a daily written log, and oral reports of the patients		immediately after the treatment	Yes
Secondary	Adverse events		at end of treatment	Yes